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Monday, January 17, 2022

Here are today's important updates:

Vaccines

Effectiveness of Pfizer Vaccine Against Critical COVID-19 in Adolescents
This case-control, test-negative design study involved 445 patients and 777 controls at 31 hospitals in 23 states. In hospitalized adolescent patients, vaccine efficacy against hospitalization was 94% (95% CI, 90-96), 98% against ICU admission and 98% against COVID-19 resulting in the receipt of life support. There were no deaths in the vaccinated. Of note, 40% of the case patients were admitted to the ICU (only two had been vaccinated) and 29% required life support. This study took place during the Delta peak. Take home message: While the need for hospitalization may be low in adolescents, nearly half of those hospitalized need ICU care and almost one-third require life support. The Pfizer vaccine is highly effective against these outcomes.
 
Booster Benefit Among Younger Healthcare Workers in Israel
Like an earlier study on immunocompetent healthcare workers over the age of 60, administration of a third dose of the Pfizer vaccine to younger healthcare workers was associated with a lower rate of infection compared to those without a booster in this study. The adjusted hazard ratio was 0.07.
 
Antibody Titers as Correlates of Protection
This NIH-funded study analyzed blood samples from more than 1,000 people who had received the Moderna vaccine as part of the Coronavirus Efficacy (COVE) trial. Antibodies measured included spike protein binding antibodies and neutralizing antibodies. Data showed that for those with the highest antibody levels, the vaccine offered an estimated 98% protection. Those with levels about 1,000 times lower had 78% protection. Based on any of the antibodies tested, the estimated COVID-19 risk was about 10 times lower for vaccine recipients with antibodies in the top 10 percent of values compared to those with antibodies that weren’t detectable. This ability to correlate antibody levels with protection will help predict vaccine efficacy in groups in a much shorter time period than a conventional trial (2 months versus 7 months). Antibody levels are not precise enough to predict when someone would need a booster.

Immunity

Cross-Reactive Memory T Cells Protective?
A study from the National Heart and Lung Institute in the United Kingdom on 52 COVID-19 household contacts found higher frequencies of human endemic coronaviruses cross-reactive nucleocapsid-specific memory T-cells in contacts who remained PCR-negative after household contacts, compared to those who converted to PCR-positive. There was no difference in the frequency of spike-specific T-cells.

Infection

CDC Updates Guidelines for Isolation and Quarantine
On January 9, the CDC updated their guidelines for those in the general community, clarifying the guidelines that were updated on December 31 and covered in our last Task Force message. There were no changes in the duration as outlined in the earlier guidelines, but on a Clinician Outreach and Communication Activity (COCA) call on January 13 the CDC gave their reasons for the shortened duration: societal issues related to prolonged isolation, staffing issues for essential services, supply shortages and the fact that Omicron has a shorter incubation period, and the peak infectious period is from 1 day before to 1 week after symptom onset. Most of the public has focused on the 5-day duration for isolation (confirmed infection or likely infected), but key points that are often forgotten: These shortened guidelines apply to mild or asymptomatic disease only, and those over the age of 2 (<2 can’t wear a mask). Additional recommendations as part of the guidelines are often not stated but crucial: Wear a tight-fitting mask including indoors at home, avoid travel, stay away from immunocompromised or high-risk people, and avoid places where you can’t wear a mask for the next 5 days. They also clarified the difference between “fully vaccinated” and “up-to-date vaccination”. Fully vaccinated refers to those who have completed a two-dose mRNA vaccine series or a one-dose J&J vaccine, but have not been boosted if eligible. Up-to-date vaccination refers to those who are fully vaccinated and have received a booster if eligible. There are differences in the quarantine guidelines for fully vaccinated versus up-to-date. Those who are up-to-date on their vaccines and those within 90 days of a confirmed COVID-19 infection do not need to quarantine after close contact with a person with a confirmed COVID-19 infection, but should wear a mask around others for 10 days and get tested at least 5 days after contact, sooner if symptomatic. For those who are fully vaccinated but not up-to-date, with close contact to a person with a confirmed COVID-19 infection, stay at home for 5 days, wear a well-fitting mask when around others at home as well as elsewhere, if possible, for 10 days, monitor symptoms for 10 days, and get tested at 5 days. Slides from the call can be found here.
 
Choosing a Proper Mask and Avoiding Counterfeit Masks
The CDC updated their recommendations and guidance on masks on January 14. N95, KN95 and KF94 masks are recommended. If you wear a cloth mask, make sure it has at least two layers of cloth and fits tightly. If you can’t tolerate or find an N95 or equivalent, then consider wearing two masks, a procedure mask with a cloth mask over the top. “Surgical N95s” are a specific type of N95 and should be reserved for healthcare settings. Share this link with your staff and patients. Counterfeit masks are of special concern. 60% of KN95s are counterfeit, and many of the N95s. This article from NBC News offers helpful tips on spotting the counterfeit masks. The biggest tip when shopping for KN95s is: If it has the “NIOSH” markings, it is counterfeit because NIOSH does not certify KN95 masks. You can find which masks are certified by NIOSH here. Additional tips are also available at this CDC website.
 
Concurrent Influenza and SARS-CoV-2 Infection
Labeled “flurona” by the press, patients who have simultaneous infection with both influenza and SARS-CoV-2 are being increasingly reported in the United States and around the world. There are not enough cases to know if this combination will cause more severe disease, but some have been mild, particularly those who have been vaccinated for both and boosted for SARS-CoV-2. With increasing cases of influenza being reported in the United States and the Omicron surges, it is likely to see more of these cases. Since there are potential therapies for both, it makes sense to test for both in patients presenting with lower respiratory symptoms. Take home messages: Encourage vaccination for influenza and SARS-CoV-2, which can be given simultaneously. Encourage masking and think of the potential for both infections in sick patients.
 
HAE Attacks Increase But No Increased Risk for COVID-19 Severity
This small study conducted at 10 HAE reference centers in Latin America noted an increase in the frequency of attacks in HAE patients with confirmed SARS-CoV-2 infection, but no evidence for increased severity of infection in this patient population.

Testing

Insurers to Cover At-Home Testing
According to news sources, private health insurers are now required to cover up to eight home COVID-19 tests per month for people on their plans. People will be able to purchase home testing kits for free under their insurance or submit receipts for reimbursement (up to $12 per test). The program will allow insurers to set up networks of preferred suppliers to make tests available with no up-front costs.
 
Stop Using LuSys Laboratories COVID-19 Tests
An FDA safety communication was released on January 11 warning people to stop using LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. These may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. Performance of these tests have not been adequately established, may produce false results and neither test has been authorized, cleared or approved by the FDA for distribution or use in the United States.
 
Free Antigen Tests for Families
Beginning on January 19, individuals may order free antigen tests for COVID-19 from the federal government through the website COVIDTests.gov. The limit is four tests per family. You can expect them to be shipped 7-12 days after ordering and to be delivered by the U.S. Postal Service. Delivery may take 2-3 days after shipping. Several news agencies carried this report, including AP, CNN, and the New York Times.

Misinformation

First Masks, Then Vaccines, Now Antigen Tests
The purveyors of misinformation and disinformation never rest. This New York Times article points out several social media sources trying to discredit at-home COVID-19 antigen tests. Allergists need to be aware of these claims and be ready to comment on them to their patients. For those without a subscription, the claims include that the tests are not accurate because tap water, soft drinks and juices can cause a positive test (may be true but doesn’t affect the results of the test when used correctly) and other distortions about PCR testing.

Treatment

Racial and Ethnic Disparities in Use of Monoclonal Antibodies
Analysis of data from 41 healthcare systems participating in the National Patient-Centered Clinical Research Network found lower use of monoclonal antibody treatment among Black, Asian, and other race and Hispanic patients with positive SARS-CoV-2 test results, relative to White and non-Hispanic patients. Racial and ethnic differences were smaller for inpatient administration of remdesivir and dexamethasone.

Practice

Provider Relief Fund (PRF) Reporting Portal Open
This portal is open for providers required to report on PRF payments during Reporting Period 2. The portal will remain open until March 31. Learn more here.
 
HHS Extends Public Health Emergency
The Secretary of the Department of Heath and Human Services (HHS) announced his intent to extend the public health emergency (PHE) for another 90 days, until April 16, 2022. This means that all waivers instituted by CMS and HHS for the PHE will also be extended.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.
 
Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, January 10, 2022

Here are today's important updates:

Vaccines

ACIP and CDC Concur With FDA Authorization
Shortly after the FDA expanded the EUA for the Pfizer vaccine, the CDC approved the indications: boosters for 12-years-old and above 5 months or more after their second dose, and a third dose 28 days after their second dose for 5-11-year-olds who are immunocompromised. On January 7, the FDA also amended the EUA for Moderna to allow a booster after 5 months. See here and here for more details.
 
Adverse Events Reported After Pfizer Vaccine in 5-11-Year-Olds
After nearly 8.7 million doses, serious adverse events were rarely reported to VAERS and V-safe. Fever, headache and fatigue were the most common systemic symptoms, usually mild to moderate. Of the 4,149 VAERS reports, 100 (2.4%) were for serious events, the most common were fever (29), vomiting (21) and increased troponin (15). There were 12 reports of seizures: two were febrile seizures and 5 were new onset seizures. Eleven of 15 of the preliminary reports of myocarditis were verified, all mild.
 
Vaccine Effectiveness in Adolescents
A prospective cohort of 243 adolescents aged 12-17 years in Arizona completed weekly SARS-CoV-2 testing by nasal swab for 19 consecutive weeks. Under real-world conditions, vaccine effectiveness of full immunization (completion of the second in a two-dose series at least 14 days earlier) was 92% against SARS-CoV-2 infections irrespective of symptom status.
 
Vaccine May Reduce MIS-C in Adolescents
In a study involving all pediatric patients in France admitted or diagnosed with Multisystem Inflammatory Condition – Children (MIS-C) from September 1 – October 31, 2021, the HR for MIS-C was 0.09 (95% CI, 0.04-0.21) after the first vaccine dose compared with unvaccinated adolescents. In a U.S. study, the CDC in collaboration with 70 pediatric hospitals found an estimated effectiveness of the Pfizer vaccine against MIS-C occurrence in 12-18-year-olds was 91%.
 
Neutralizing Antibody Titers After Infection, Vaccination and Both
This study looked at serum neutralizing antibody titers against USA-WA/2020-spike pseudotype virus in 497 participants, 170 after previous infection, 327 after vaccination, and 50 after infection and then vaccination. Among 170 unvaccinated participants with SARS-CoV-2 infection, 158 (93%) developed neutralizing antibodies (nAb) with a GMT of 1,003 (95% CI=766-1,315). Among 139 previously uninfected participants, 138 (99%) developed nAb after mRNA vaccine dose two with a GMT of 3,257 (95% CI=2,596-4,052). GMT was higher among those receiving mRNA-1273 vaccine (GMT=4,698, 95%CI=3,186-6,926) compared to BNT162b2 vaccine (GMT=2,309, 95%CI=1,825-2,919). Among 32 participants with prior SARS-CoV-2 infection, GMT was 21,655 (95% CI=14,766-31,756) after mRNA vaccine dose one, without further increase after dose two. Take-home message: Vaccination provides greater protection than infection, and vaccination after infection provides the greatest protection.
 
Impact of Omicron Spike Protein Mutations
Fifteen of the 37 amino acid substitutions in the Omicron variant are in the receptor-binding domain (RBD), which leads to the question of these substitutions on binding and response to therapeutics and vaccines. Until now, most of the information has been in pre-print form. This peer-reviewed and accepted study employed a pseudovirus assay to study receptor usage and neutralization mediated by monoclonal and polyclonal antibodies, as well as surface plasmon resonance to measure binding of the RBD to human and mouse ACE2 receptor. Findings: Omicron RBD binds with increased affinity (2.4-fold) to human ACE2 receptors and also gains binding to mouse ACE2, suggesting the possibility of human-animal-human transmission, although passage through an animal species could also attenuate the virus; mRNA vaccines had some neutralizing activity but was reduced 37-39-fold; reduction in vaccinated and previously infected patients was 5-fold, and reduction in renal dialysis patients after a booster dose was 4-fold; only one of the currently approved monoclonal antibodies (sotrovimub, which targets non-RBD epitopes) had neutralizing activity against Omicron with only a 2-fold reduction. The authors did identify a few broadly neutralizing antibodies that were effective against the Omicron variant and many other non-SARS-CoV-2 sarbecoviruses. Similar findings of increased neutralizing response in boosted as well as previously infected and vaccinated individuals were noted in this study.

Infection

Antigen Test Sensitivity and Omicron
You may have read about this in the news. Here is the information directly from the FDA: “The FDA is collaborating with the National Institutes of Health’s (NIH) RADx program to study the performance of antigen tests with patient samples that have the Omicron variant. RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term. Early data suggests that antigen tests do detect the Omicron variant but may have reduced sensitivity.” Prior testing by RADx on heat-treated patient samples suggested that these tests had similar performance when detecting other variants.
 
Increasing Hospitalization Rate in Children
Over the last two weeks, the rate of hospitalization in children (0-17-year-olds) has almost quadrupled, from 0.26/100,000 on December 15, 2021, to 0.92/100,000 on January 2, 2022, according to the CDC. Reasons behind this increase are not clear. Part of the explanation could be that many children may be hospitalized for another reason, but test positive for SARS-CoV-2 on admission. Since the start of the COVID-19 pandemic, 209 children have died from this disease. Since August of 2020, there have been over 80,000 admissions. Only 24% of children 5-11 have received one vaccination, and only slightly more than 15% are fully vaccinated. Most admissions now are preventable. (CDC Data Tracker as noted).
 
Increased Risk for Diabetes Post-COVID in Those <18-Years-Old
Data from two claims databases found that new diabetes diagnoses were 166% (IQVIA) and 31% (HealthVerity) more likely to occur among patients <18-years-old with COVID-19 than among those without COVID-19 during the pandemic, and 116% more likely to occur among those with COVID-19 than among those with an acute respiratory infection during the prepandemic period. Non-SARS-CoV-2 respiratory infection was not associated with diabetes. These findings are consistent with previous research demonstrating an association between SARS-CoV-2 infection and diabetes in adults. Bottom line is that providers should be on the lookout for diabetes >30 days post COVID in patients <18-years-old (and probably in all patients, given the references listed at the end). An interesting hypothesis on the mechanism underlying this risk can be found in this paper.
 
Risk for Severe Disease Among Hospitalized Adults With Asthma or COPD
A group of authors from the CDC, using data from 877 U.S. hospitals from the Premier Healthcare Database, assessed the risk of severe clinical outcomes during hospitalization of adults with asthma and/or COPD and COVID-19, and compared those risks with those during hospitalizations of adults with asthma and/or COPD without COVID-19. They found that among patients with asthma, the percentage requiring ICU admission, invasive mechanical ventilation (IMV) and death were 46.9%, 14.0% and 8.0% respectively. The risks were higher compared to those without COVID-19, with adjusted risk ratios of 1.17 (95% CI, 1.14-1.21), 1.61 (95% CI, 1.50-1.73), and 5.56 (95% CI, 4.89-6.32) respectively. Risks were also higher among adults with COPD.

Practice

CMS Announces Changes for Vaccination and Monoclonal Antibody Treatment
If you vaccinate or administer monoclonal antibody to patients enrolled in MA plans on or after January 1, 2022, you should submit claims to the MA plan. Original Medicare won’t pay those claims. Read more here.
 
Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.
 
Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, January 4, 2022

Here are today's important updates:

Vaccine

FDA Announces Extension of EUA for Pfizer Vaccine Boosters
On a media call on January 3, the FDA announced several changes. First, they extended the EUA for the Pfizer vaccine to include 12-15-year-olds. They reviewed the Israeli data on myocarditis after the third dose in this age group and found that it was about one-third the risk compared to after the second dose. The peak age range for myocarditis was in the 16-17-year-old age range, about 1 in 10,000 and was mild in 98% of cases. They also announced a change in the booster timing, now authorized at 5 months after the second dose for Pfizer (Moderna remains at 6 months). Finally, they authorized a third dose in 5-11-year-olds who may be immunocompromised. Remember, these are authorizations for the vaccine. The ACIP and CDC have to weigh in on this and give their recommendations for using the vaccines as authorized in these age groups.
 
Boosters Markedly Reduce Infection
Data published in early December by the Massachusetts Department of Health showed that unvaccinated individuals were five times more likely to be infected compared to those fully vaccinated but not boosted, and 31 times as likely compared to those fully vaccinated and boosted. These numbers likely preceded the Omicron wave.
 
Pfizer Vaccine Efficacy Against Hospitalization Caused By the Omicron Variant
This has been widely covered in the press, but here is a published report. Using data from a South African managed care organization involving over 30,000 individuals, the effectiveness of the vaccine was 70% against hospitalization for those fully vaccinated (two doses) compared to an effectiveness of 93% during their period of Delta predominance.
 
Pfizer/BioNTech Announce Modification of 6-Month-Old to 5-Year-Old Vaccine Clinical Trial
In a December 17 press release, the companies announced that following a routine review by the Data Monitoring Committee, they will amend the clinical study to include evaluating a third 3 microgram dose at least 2 months after the second dose of the two-dose series. In a pre-specified immunogenicity analysis, compared to the 16-25-year-old population, non-inferiority was met for the 6-24-month-old age group but not the 2-5-year-old group. No safety concerns were noted. If the three-dose study is successful, the companies expect to submit for an EUA in the first half of 2022.
 
Neutralization of Omicron After Pfizer Booster Dose
Using microneutralization assays against the wild-type virus, Beta, Delta and Omicron variants, these authors from Israel found that the third dose efficiently neutralized infection with the Omicron variant, increasing the neutralization efficiency by 100-fold, but it was four-fold lower than the efficiency against the Delta variant.
 
Factors Associated With Vaccine Reactions
In this online cohort study in 19,586 participants, anaphylaxis or allergic reactions occurred in 0.3% after one dose and 0.2% after two doses. Factors associated with adverse reactions in general were number of doses of vaccine, mRNA vaccine, with Moderna more than Pfizer, younger age, female sex and previous COVID-19 infection. Major limitation of this study is the self-report of allergic or anaphylactic reactions. Overall, these reactions were very uncommon. Another study from the Kaiser Permanente Southern California system analyzing data on 391,123 vaccine recipients, noted a rate of treated first dose hypersensitivity reaction of 0.028%, and a second dose treated reaction rate of 0.014%. Only 0.00033% resulted in anaphylaxis. Nearly 80% of first dose reactors were able to get the second dose. 7.8% of those with first dose reactions who had a second dose had a subsequent reaction. Recipients with preexisting drug “allergies” were more likely to have a reaction. The figures from this study are more likely to represent the real incidence of reactions because they only looked at treated reactions, not reported reactions.
 
Tolerance of mRNA Vaccines in PEG Allergic Individuals
This study from Canada found that in 12 patients with either confirmed or highly likely PEG allergies, all were able to be safely vaccinated, 10 with mRNA vaccines. This included two individuals with positive ID tests to the vaccine. Some of the patients were given the vaccine in divided doses, the others as a single dose.
 
CMS Omnibus COVID-19 Healthcare Staff Vaccination
On December 29, the Centers for Medicare & Medicaid Services (CMS) released guidance on the Omnibus COVID-19 Healthcare Staff Vaccination Interim Final Rule that was published on November 5. This guidance provides important information on implementation, as well as guidelines to assess and maintain compliance with the COVID-19 vaccination requirements for healthcare workers at facilities participating in the Medicare and Medicaid programs. This guidance does not currently apply to the following states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming. Even though the guidance uses the term “facilities participating in Medicare and Medicaid programs”, it does not apply to private offices unless you are practicing in a Rural Health Clinic or Federally Qualified Health Center. You may have requirements based on your capacity as staff in a hospital if you provide care to patients in that facility.

Infection

Omicron and Severe Disease
In one of the first peer-reviewed studies from South Africa, this group compared the characteristics and outcomes of hospitalized patients during the Omicron wave with previous waves in a large hospital system. The number of patients treated in the hospitals was about one-third those in previous waves, 41.3% of patients presenting to the ER were admitted compared to 69%, median age of patients was 36 years compared to 59, significantly fewer had co-morbidities, those presenting with an acute respiratory condition was 31.6% compared to 91%, oxygen therapy was required in 17.6% versus 74%, and ICU admission in 18.5% compared to 30%. Mortality rate was 2.7% compared to 18.5-29.1% in previous waves. Two-thirds were unvaccinated. Some of these differences could be explained by the younger age of the patients, but it appears the variant causes less lower respiratory disease. Another study from Scotland, not yet peer-reviewed, showed that Omicron was associated with a two-thirds reduction in the risk of COVID-19 hospitalization when compared to Delta and the booster dose offered substantial additional protection against the risk of symptomatic COVID-19. Important note: These cases in Scotland were predominantly in the age group of 20-39 years. The jury is still out on risk for those over 65 years. An analysis by the U.K. Health Security Agency found that someone infected with the Omicron variant is estimated to be between 31% and 45% less likely to attend emergency care and 50-70% less likely to be admitted to the hospital. The Agency stated that the findings are preliminary and highly uncertain because of the small numbers of hospitalized patients with Omicron (132) and the limited spread into older age groups.
 
CDC Changes Quarantine/Isolation Recommendations for the General Population
Based on current knowledge of COVID-19 and the Omicron variant, on December 27 the CDC changed their recommendations concerning quarantine and isolation. They shortened the recommended time for isolation from 10 days for people with COVID-19 to 5 days, if asymptomatic, followed by 5 days of wearing a mask when around others. They also updated the recommended quarantine period for those exposed to COVID-19. For people who are unvaccinated or are more than 6 months out from their second mRNA dose (or more than 2 months after the J&J) and not yet boosted, quarantine for 5 days followed by followed by strict mask use for an additional 5 days. Alternatively, if a 5-day quarantine is not feasible, it is imperative that an exposed person wear a well-fitting mask at all times when around others for 10 days after exposure. Individuals who have received their booster shot do not need to quarantine following an exposure but should wear a mask when around others for 10 days after exposure. For all those exposed, best practice would also include a test for SARS-CoV-2 at day 5 after exposure. If symptoms occur, individuals should immediately quarantine until a negative test result. These new guidelines do not apply to healthcare workers, those remain unchanged from the December 23 update.
 
40.5% of Those With Confirmed COVID-19 Are Asymptomatic
Numerous studies have reported percentages of asymptomatic patients with COVID-19 that have varied from 20-50%. To a large extent, it varies depending on the population studied and perhaps the variant involved. This systematic review and meta-analysis on 29,776,306 individuals undergoing testing from 95 unique studies showed that the pooled percentage of asymptomatic infections was 40.5% among the population with confirmed COVID-19. These studies were done prior to Omicron, so we don’t know if this percentage will hold for that variant.

Treatment

Remdesivir Found Effective At Prevention of Hospitalization
This randomized, double-blind, placebo-controlled trial in 562 non-hospitalized patients with symptomatic COVID-19 infection within the previous 7 days and having at least one risk factor for severe disease was able to demonstrate that a 3-day course of remdesivir resulted in an 87% lower risk of hospitalization or death (HR 0.13 ;95% CI, 0.03-0.59). Adverse events were comparable to placebo, most common was nausea. These results are comparable to those achieved with Paxlovid, and almost three times better than molnupiravir. Important note: This study was performed before the Omicron variant was circulating. Data on effectiveness for that variant is limited, but should be effective based on in vitro data.
 
CDC Health Alert on Therapeutics to Prevent and Treat COVID-19
This alert was just released on December 31. In a given infected patient, you are most likely not going to know which variant is responsible, and timing is of the essence. You will have to rely on data on the most likely variant in your area. Monoclonal antibodies (bamlanivimab plus etesevimab, casirivimab plus imdevimab) are not effective against Omicron. Sotrovimab is effective but in short supply and use should be limited to nonhospitalized high-risk individuals including those who are unvaccinated or have not received a booster, older age (>65) or immunosuppressed. If Delta is still prominent in your area, you could use bamlanivimab plus etesevimab or casirivimab plus imdevimab, but should counsel your patient on potential lack of effectiveness. Some PCR tests that can identify SGTF (s-gene transcription failure) variants may be helpful in suggesting Omicron. Antivirals: remdesivir (see study above). Paxlovid and molnupiravir must be started within 5 days of symptoms onset, and is indicated for mild-moderate disease in nonhospitalized patients. There is marked difference in effectiveness (Paxlovid 88%, molnupiravir 30%). Paxlovid supplies are very limited so use should be limited to higher risk patients and those who are not limited due to the severe drug-drug interactions associated with the ritonavir component. CDC strongly recommends that healthcare providers who are not familiar with these potential interactions should refer to the NIH Statement on Paxlovid Drug-Drug Interactions/COVID-19 Treatment Guidelines. Molnupiravir is not recommended in pregnancy, people who are breast-feeding, or pediatric patients. Paxlovid is authorized (EUA) for pediatric patients 12 years and older who weigh at least 40kg. Pre-exposure therapeutics for high-risk groups: EVUSHELD, which contains two long-acting monoclonal antibodies, is the only EUA pre-exposure prophylactic product available, should be effective against Omicron, and is intended for the highest risk immunocompromised patients who are not expected to have an effective response to vaccination. This product is not indicated for treatment, only prophylaxis. This document provides a tiered approach to prioritization.
 
Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.
 
Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Thursday, December 23, 2021

Many of our patients consider their allergist to be their primary physician, and may call us with symptoms or a confirmed case of COVID-19. It is important for us to be aware of all possible treatments that need to be given early in the course of the disease.

On Wednesday, 12/22/21, the FDA granted an EUA for a new anti-viral medication for treatment of COVID-19 called Paxlovid (nirmatrelvir/ritonavir). This drug is indicated for the treatment of outpatients 12 years of age and older (weighing at least 40kg) with mild-moderate symptoms of confirmed COVID-19 within five days of symptom onset and who are at high risk for severe disease.

It should be started within three days of the onset of symptoms, but studies suggest that it might still be effective within five days. The pivotal clinical trial in high-risk patients showed that this drug was 89% effective in preventing hospitalization or death. There was a 94% reduction in people over age 65. A second trial is being conducted in standard-risk patients but hasn’t been completed yet.

Nirmatrelvir was derived from a precursor that was active against SARS and designed specifically for SARS-CoV-2. It binds to the virus’s main protease to inhibit replication. Paxlovid combines nirmatrelvir with ritonavir, a viral protease used for HIV, which has no effect against SARS-CoV-2 but works to increase the blood levels of nirmatrelvir.

The dose is two 150mg tablets of nirmatrelvir and one 100mg tablet of ritonavir twice daily for five days.

Possible side effects include an impaired sense of taste, diarrhea, high blood pressure and muscle aches. Be aware of potentially significant drug interactions, and use with caution in patients with HIV or liver disease.

This drug only treats acute disease and the patient will remain potentially susceptible to repeat infection. Paxlovid is not a preventative medication and is not a substitution for vaccination.

Initial supplies will be limited with only enough medication for 180,000 patients by the end of the year and an additional 30 million by the middle of 2022. It takes six to eight months to manufacture the drug.

The Fact Sheet for healthcare providers can be found here.

Today, 12/23/21, the FDA also granted an EUA to molnupiravir for people 18 years of age and older who are at high risk of severe COVID-19. Clinical trials of this drug show a reduction in hospitalization of 30%. This drug has fewer interactions with other medications compared to nirmatrelvir and fewer issues with liver disease. You can read the FDA’s press release on this medication here.


Monday, December 20, 2021

Here are today's important updates:

Omicron

The material on Omicron is not from peer-reviewed published papers (too soon for that) but relies on press releases, NIH newsletters and pre-print results of studies. Please take this into account, information will most likely change over time. Best advice at this time: If you have been vaccinated, get a booster. If not vaccinated, start. If you have been previously infected, vaccination will markedly increase your protection. Wear a mask indoors, continue social distancing and frequent hand washing. Remember, Delta continues to be the main variant circulating in the United States at this time.

Current EpidemiologyOmicron has been confirmed in 45 states, but probably is present in all 50. It appears to be rapidly increasing with 40% or more of new U.K. cases due to this variant. This MMWR article explains the enhanced surveillance currently undertaken to track it. In Washington state, which started with three cases in early December, researchers at the University of Washington found that the number of positive samples rose from 3% to 13% in just 3 days. Omicron now accounts for 40% of positive tests in the state based on S protein deletion picked up on PCR testing. The CDC predicts that Omicron could peak in a massive wave of infections as soon as January. In the New York/New Jersey area, the percentage of Omicron infections had reached 13.1% in the week ending December 11.

TransmissionU.K. data from 260 confirmed cases of Omicron indicate that the Omicron variant has about 3.2 times the risk of household transmission compared to Delta, and the household secondary attack rate is about twice that of Delta. Preliminary analyses indicate approximately 3-8-fold increased risk of reinfection with the Omicron variant. Commentary on the South African data indicate a doubling time for cases of 1.2 days, compared to 1.5 days for Delta.

Does It Cause Milder Disease?According to a report in the Washington Post on December 8, Botswana, one of the first countries to detect Omicron, had not seen a rise in hospitalizations. 71% of its 1.3 million eligible population is fully vaccinated. The WHO also stated that preliminary data presents a rapid increase in transmission but causes milder cases than Delta, although it is too early to be sure. The reassuring data from Botswana could be due to vaccination or mild disease from this variant. Details from 43 cases in the United States attributed to the variant from the above mentioned MMWR article include:

  • 58% of cases were in the 18-39-year-old age range (important when considering morbidity and mortality), only 33% reported international travel
  • 79% were fully vaccinated, 33% had received a booster dose, although one-third of these <14 days before symptom onset
  • 14% had a documented previous SARS-CoV-2 infection
  • Most common symptoms: cough, fatigue and runny nose/congestion
  • One person hospitalized for 2 days, no deaths reported as of December 8 among this group

The U.K. data on the 260 confirmed cases also mentioned above had no deaths or hospitalization.

Are Vaccines Protective?Early data out of South Africa, in a study involving a small number of patients (12) and not yet peer reviewed, found that neutralizing antibodies were 40 times less effective after two doses in six of the patients, but still showed protection in another six who had been infected previously and had two doses of vaccine (surrogate for a booster dose). Pfizer confirmed this with their own laboratory research. Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 vaccine neutralize the Omicron variant (B.1.1.529 lineage), while two doses show significantly reduced neutralization titers. Data indicate that a third dose of BNT162b2 increases the neutralizing antibody titers by 25-fold compared to two doses against the Omicron variant; titers after the booster dose are comparable to titers observed after two doses against the wild-type virus, which are associated with high levels of protection. As 80% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, two doses may still induce protection against severe disease.

Much of the data reported so far relates to anti-spike and neutralizing antibodies. Alessandro Sette, PhD, of the La Jolla Institute for Immunology, reports that his lab shows high conservation of T cell epitopes in Omicron. A pre-print on real-world U.K. data showed vaccine effectiveness about 4 months after two doses of the Pfizer vaccine was about 40% against Omicron, but a booster dose increased the vaccine effectiveness to about 80%.

Is Previous Infection Protective?pre-print study from Austria using sera from people previously infected with Alpha, Beta or Delta antibodies failed to neutralize Omicron, but antibodies from patients with previous infection from other variants who were also vaccinated showed some neutralization.

And the Misinformation Beats the Real InformationThis article in the Washington Post notes that anti-vaccine influencers at the end of November reposted a fake slide deck with the logos of the WHO and World Economic Forum purporting to show a schedule for when coronavirus variants would be “released” that was originally posted last July. Other false claims: the vaccines caused the Omicron variant (reposted millions of times on Telegram messaging app), the variant is being pushed by the government and pharmaceutical companies to undermine ivermectin, and that the timing of the variant suggests that government officials are trying to distract people from following the trial of Ghislaine Maxwell.

Vaccines

Efficacy of Booster Doses Across Age RangesData from Israel on 4,696,865 persons ages 16 years or older who had received two doses of Pfizer vaccine at least 5 months earlier indicated that the rate of confirmed infection was lower in the booster group compared to the non-booster group by a factor of 10. The rates of severe illness were lower by a factor of 17.9 among those 60 years and older, and by a factor of 21.7 in those ages 40-59. Mortality among those 60 and older was lower by a factor of 14.7.

FDA Expands Pfizer EUAThe FDA has granted an extension to the EUA for the Pfizer vaccine to include booster doses for 16- and 17-year olds.

FDA and CDC Modify Recommendations for the J&J VaccineEarlier this month, the FDA announced people who have a history of thrombosis with thrombocytopenia (TTS) should not get the J&J vaccine. The CDC’s Advisory Committee for Immunization Practices (ACIP) met on December 16 and voted in favor of expressing a preference for the mRNA vaccines, but stopped short of saying that use of the J&J vaccine should be discontinued. There have been 54 cases of TTS after the J&J vaccine as of August 31, a rate of 3.83 cases per million doses. Males and females ages 18-70 have been affected with the highest rate among females ages 30-49 (about 10 per million doses). Just over half the cases have a cerebral venous sinus thrombosis, and there have been 9 deaths as of December 9. In the risk/benefit analysis, vaccination with the J&J vaccine will prevent 3,700-64,000 hospitalizations due to COVID-10 depending on age, so the risk/benefit still favors vaccination. Since the J&J vaccine has been the go-to recommendation from allergists for those who have had a severe allergic reaction to one of the mRNA vaccines, this information will be important to present to our patients in shared-decision making about vaccine choices. Slides from the ACIP meeting and the COCA call on December 17 are available here and here.

Myocarditis After Vaccination Mild, Resolves QuicklyThis retrospective analysis of 139 adolescents and young adults <21 years-old with 140 episodes of suspected myocarditis within 30 days of COVID-19 vaccination found that most had mild symptoms that resolved quickly. 96.8% followed an mRNA vaccine, with 91.4% after the second dose, a median of two days later. Chest pain was the presenting symptom in 99.3%, less than one-third with dyspnea or fever, and all had elevated troponin. Median hospital stay was two days. Information from the ACIP meeting on December 17 noted that there have been eight confirmed cases of myocarditis in the 5-11-year-old patients, out of 7 million doses. All cases have been mild.

Appeals Court Revives Administration's COVID-19 Vaccine Mandate For Healthcare Workers in 26 StatesReuters reported on December 15 that the U.S. Court of Appeals for the Fifth Circuit “on Wednesday revived in 26 U.S. states a COVID-19 mandate issued by President Joe Biden’s administration requiring millions of healthcare workers to get vaccinated if they work in facilities that receive federal dollars.” The three-judge panel “ruled that a lower court had the authority to block the mandate in only the 14 states that had sued and was wrong to impose a nationwide injunction.”

Treatment

FDA Grants EUA for AstraZeneca Monoclonal Antibody TreatmentOn December 8, the FDA granted an EUA for Evusheld (tixagevimab + cilgavimab) for pre-exposure prophylaxis of COVID-19 in persons 12 years of age (weighing at least 88 pounds) and older who are moderately to severely immunocompromised or have a history of severe adverse reactions to a COVID-19 vaccine or its components. This is a long-lasting monoclonal antibody administered as two IM injections in immediate succession and may be effective for prevention for 6 months.

Remember Monoclonal Antibody TherapyIt is often forgotten in patients with mild-moderate COVID-19 and at high risk for severe disease, and also for post-exposure prophylaxis. Find out more on the COVID-19 resources page on the AAAAI website. Pre-print studies here and here indicate that the monoclonal antibodies from Lilly, Regeneron and AstraZeneca may not be effective against Omicron, but that the GSK product, Sotrovimab, remains effective. On the other hand, the Washington Post mentioned in an article on December 16 that an independent study by scientists at the FDA found that the Astra Zeneca product, Evusheld, retained activity against Omicron. It is important to remember, with all the news about Omicron, that 95% or more of current infections in the United States are due to Delta, which does respond to the current licensed monoclonal antibodies.

Infection

Asthma Control and Hospitalization for COVID-19 in ChildrenThere have been over 100 articles including meta-analyses indicating that asthma is not a risk factor for severe COVID-19 and this has certainly been the case in the United States. Things may be different in the United Kingdom, however, with two studies suggesting that asthma may be a risk factor. A national incident cohort study of 63,463 children with asthma in Scotland looked specifically at asthma patients who were controlled versus uncontrolled based on a previous hospital admission, or two or more courses of oral steroids in the previous year. The HR for hospitalization for those with a previous asthma admission was 6.40 (95% CI 3.27-12.53), compared to those with controlled asthma whose HR was 1.36 (95% CI 1.02-1.80), compared to those with no asthma. In those with two previous courses of oral steroids, the HR for uncontrolled asthma was 3.38 (95% CI 1.84-6.21). Why are things different in the United Kingdom? Patients more readily admitted because of universal health care, and bias toward admission in someone with cough and shortness of breath with a history of exacerbations? As always, do your best to be sure that your pediatric asthma patients are well controlled.

Practice

Financial Relief May Be on Your WayHHS announced on December 14 that $9 billion is being distributed to practitioners as part of the Phase 4 Provider Relief Fund payments. The average amount for small providers is $58,000, for medium providers $289,000, and for large providers $1.7 million. HRSA is currently reviewing the remaining Phase 4 applications and will make the remainder of Phase 4 payments in 2022.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAIChair of the AAAAI COVID-19 Response Task Force


Monday, December 6, 2021

Here are today's important updates:

Omicron (B.1.1.529)

Limited Solid Information At This Time, But What We Do KnowAll of the data is in preprint form without peer review. Thanks to Katelyn Jetelina, PhD, our friendly local epidemiologist from University of Texas, Austin, for sharing this info. The rate of reinfection with Omicron is three times higher than with Delta, so people with previous infection are not as safe from reinfection with Omicron. Disease is exploding in South Africa now, but we don’t yet know if this is just because of Omicron. We still don’t know if it is more transmissible or more severe, but expect more information in the upcoming weeks. Although South Africa is experiencing exponential growth in cases and case positivity rates as high as 24%, cases had been low in South Africa before this, and they had little impact from Delta before Omicron. Symptoms appear to be the same with this variant, although details are still lacking.

Current Status in the United StatesCases of Omicron have now been detected at least 17 states. Not all of these have been directly linked to travel to South Africa and surrounding effected countries, suggesting community spread.

Vaccines

Will Vaccines Help Against Omicron?Vaccination or boosters are recommended now, and although we can’t be sure this will protect us from Omicron, waiting for the development and approval of a modified vaccine is not a wise choice. Delta is causing >99% of all infections in the United States now, and cases are rising again. This graph from The Economist shows how poorly we are doing with boosters in all. Data on primary vaccination for those <18 are not accurate in this graph. According to the AAP, 60% of 12-17 year-olds have received at least one dose and 51% have been fully vaccinated. 15% of 5-11 year-olds have received one dose.

Benefit of Boosters in IsraelA preliminary retrospective case-control study done in 306,710 subjects 40 years and older compared those who received a booster and those who received two doses. There was an estimated OR of 0.14 (95% CI, 0.13-0.15) of testing positive for SARS-CoV-2 28-65 days following receipt of the booster (86% reduction in odds).

Current State of Vaccine MandatesBoth CMS and OSHA mandates for healthcare workers and employees of companies with over 100 employees respectively have been temporarily halted by the courts. As of mid-September, 46 states proposed or enacted 148 legal interventions to impede or facilitate vaccine mandates. 88.5% were undertaken to impede mandates, with 11.5% to facilitate. Despite the majority of interventions to impede mandates, interventions to facilitate were more likely to be enacted (70.6% vs. 32.8%). Read more here.

Pfizer to Seek Full Authorization For Ages 12-15In a recent press release, Pfizer announced that its mRNA vaccine was 100% effective against COVID-19 measured 7 days through over 4 months after the second dose. They are also applying for an adjustment to the EUA to include boosters for 16-17 year-olds.

Treatment

Inhaled Steroids For Mild COVID-19 InfectionIn July, a previous COVID-19 Response Task Force message reported on a U.K. study of an open-labelled, parallel group randomized trial involving 146 patients of inhaled budesonide (Turbohaler) 800mcg twice daily in adults within 7 days of onset of mild COVID-19 symptoms. The result was a significant reduction in the need for ER care or hospitalization, and a more rapid reduction in symptoms. In this study published online November 22, which was a randomized, placebo controlled trial involving 400 patients treated with inhaled ciclesonide 320mcg twice daily or placebo, there was also a reduction in the need for ER care or hospitalization in the treated group, although no difference in resolution of symptoms.

FDA Advisory Panel Narrowly Recommends Approval of MolnupiravirIn a vote of 13-10, the panel recommended an EUA for Merck’s treatment, even though updated data on their ongoing clinical trial indicated a 30% reduction in severe illness compared to initial findings of 50%. There is no information yet on Pfizer’s drug.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAIChair of the AAAAI COVID-19 Response Task Force


Tuesday, November 23, 2021

Here are today's important updates:

On Behalf of the Task Force, Have a Safe and Happy ThanksgivingConsider gatherings of vaccinated individuals only. If that is not possible, outdoors is better than indoors, or consider rapid antigen testing on Tuesday and again on Thursday for those that are not fully vaccinated. These can be done at home with tests purchased at your local pharmacy.

Vaccines

Boosters Approved for AllThe FDA and CDC have approved boosters of Pfizer, Moderna and J&J for all over 18. For those ages 18-49 that have no medical comorbidities and are not at high risk because of living or work environments, a booster may be obtained. For all others, especially those over 50, a booster should be obtained.

Joint Statement Supporting OSHA COVID Vaccination or Testing RequirementThe AAAAI has joined dozens of other medical organizations, including the AMA, ACP and AAP in a joint statement urging the nation’s business community to follow OSHA’s requirement that large employers ensure their workers are fully vaccinated or tested weekly for COVID-19. For our nation to return to “normal” we need to vaccinate roughly 80 million more people. OSHA’s requirements are an important step toward getting us to that goal.

Real Life Effectiveness of a Booster DoseIn this study from Israel involving over 1,400,000 patients, those who received a third mRNA vaccine dose between July 2020 and September 2021 were matched 1:1 to demographically and clinically similar controls who had only two doses of vaccine with the second dose 5 months or more before. Vaccine effectiveness for prevention of hospitalization or death evaluated at least 7 days after receipt of the third dose, compared with only receiving two doses at least 5 months previously, was estimated to be 93% (231 events for two doses vs. 29 for three doses) for admission, 92% for severe disease (157 vs. 17 events) and 81% for death (44 vs. seven events).

Breakthrough Infection Less in Those With Prior InfectionIn a matched cohort study in Qatar involving 157,000 mRNA vaccinated patients with prior COVID-19 infection (including asymptomatic and mild disease) and 460,000 vaccinated patients without prior infection, the cumulative infection incidence was significantly lower in those with prior infection.

Vaccination Reduces Long COVIDTwo studies have shown that vaccination can reduce the incidence of long COVID or post-acute sequelae of COVID-19 (PASC). In the first study in healthcare workers from Israel, 19% of those with breakthrough infections had symptoms lasting longer than 6 weeks. In the second study, which involved over 1.2 million adults, the rate of long COVID in fully vaccinated patients with breakthrough infections was half that of unvaccinated.

Utility of Skin Testing for Evaluation of Vaccine or Potential Vaccine ReactionsThis small retrospective study from three Mayo Clinic sites evaluated 129 patients with either an allergic reaction to a first vaccine dose (55 patients) or a history of an allergic reaction to an excipient of the vaccine (74 patients). Results indicate that skin testing to PEG, polysorbate or vaccine is uncommonly positive and most patients tolerate vaccination. Only small numbers of these patients had moderate to severe anaphylaxis. The authors suggest that excipient skin testing may be of minimal value.

Do Vaccinated Healthcare Workers (HCWs) Need to Quarantine for 14 Days If COVID Positive?In this study, 2,397 fully vaccinated HCWs received PCR tests every 2-4 weeks, then daily if positive, until two consecutive tests were negative. A total of 33 workers (1.3%) tested positive and were asymptomatic. Eight (0.4%) were positive and symptomatic. All 33 of the asymptomatic cases were negative on testing the next day and subsequent tests 1 day later. IgG levels were higher in the asymptomatic compared to symptomatic cases. Because of the rapid clearance in the positive patients, the study likely missed many asymptomatic patients. Without more frequent testing, the true frequency of breakthrough asymptomatic infections cannot be determined by this study, although based on the rapid clearance of virus the authors speculate that 14-day quarantines may not be necessary.

CDC Vaccine Rollout "Close to Perfect"There have been many who have criticized the vaccine rollout in this country, but this mathematical study using a supercomputer compared the CDC strategy with 17.5 million possible strategies that also staggered rollout in phases, found that the CDC plan performed within 4% of perfect in all four measures (total deaths, cases, infections and years of life lost). U.S. vaccine rollout was close to optimal at reducing deaths and infections, according to a model comparing 17.5 million alternative approaches.

Infection

What Makes the Delta Variant More TransmissibleAn in-vitro study by investigators at Boston Children’s showed that the spike protein of the Delta variant rapidly fuses with cells for entry, using low levels of ACE2 receptor. This may contribute to its infectiousness. In another study, NIH-funded investigators, using research involving virus-like particles, discovered that a specific mutation in the N protein coding region of the Delta genome enabled the virus to pack more of its RNA code into the infected host cell, leading to increased production of fully functional new viral particles. All of the other variants of concern contain a mutation in the same region of the genome. The authors comment that the N protein could be a promising target for therapeutics.

NIH to Begin Long-Term Study of Children With COVID-19This study, supported by the NIAID, will enroll 1,000 children and young adults who previously tested positive for COVID-19 and evaluate the impact on their mental and physical health over a 3-year period. The investigators will also be looking at long-term immune responses, immunological and genetic risk factors. Household members who were not infected will serve as a cohort control. The study will take place at the NIH Clinical Research Center and the Children’s National Hospital.

Treatment

More About Pfizer's Antiviral PaxlovidPfizer has announced that they are seeking an EUA for their 5-day COVID-19 drug treatment. In the clinical trial mentioned in the previous Task Force message, the drug was 89% effective in reducing hospitalization, so much so that the trial was stopped. This compares to the 50% effectiveness of Merck’s molnupiravir. Paxlovid contains a protease inhibitor that inhibits the viral proteases that are crucial for the virus life cycle. Thus mutations in the spike protein would not alter the effectiveness of the drug. The protease inhibitor is combined with a low dose of ritonavir, which slows the metabolism of the protease inhibitor.

Early Treatment With Monoclonal Antibody SotrovimabThis ongoing phase 3 trial involving 583 high-risk patients with symptomatic COVID-19 5 days or less after symptom onset, showed a relative risk reduction for hospitalization or death of 85% (97.24% CI, 44-96). Three patients in the treated group as compared with 21 patients in the placebo group had disease progression leading to hospitalization or death.

Practice

CMS Announces Automatic Exemption for MIPS 2021 Reporting YearThis only applies to individual eligible physicians. The individuals will receive an automatic neutral payment adjustment for the 2023 MIPS payment year. The automatic exemption notably does not apply to eligible clinicians participating in groups, virtual groups, or as an Alternative Payment Model (APM) entity. CMS noted that group and APM participation is optional and individually eligible MIPS eligible clinicians will qualify for the automatic exemption if they do not report data at the group level. You can read more here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAIChair of the AAAAI COVID-19 Response Task Force


Monday, November 15, 2021

Here are today's important updates:

Vaccines

Effectiveness of mRNA Vaccine Against Hospitalization in Immunocompromised - Data From Nine StatesTo evaluate vaccine effectiveness (VE) among immunocompromised adults, data from the VISION Network on hospitalizations among persons aged 18 years and older with COVID-19–like illness from 187 hospitals in nine states during January 17–September 5, 2021 were analyzed. Using a test-negative design comparing 20,101 immunocompromised adults (10,564 [53%] of whom were fully vaccinated) and 69,116 immunocompetent adults (29,456 [43%] of whom were fully vaccinated). VE of two doses of mRNA COVID-19 vaccine against COVID-19–associated hospitalization was lower among immunocompromised patients (77%; 95% confidence interval [CI] = 74%–80%) than among immunocompetent patients (90%; 95% CI = 89%–91%). VE varied across immunocompromising condition subgroups, ranging from 59% (organ or stem cell transplant recipients) to 81% (persons with a rheumatologic or inflammatory disorder). Immunocompromised persons receiving mRNA COVID-19 vaccines should receive three doses and a booster, consistent with CDC recommendations, practice nonpharmaceutical interventions, and, if infected, be monitored closely and considered early for proven therapies that can prevent severe outcomes.

Summary of CMS and OSHA Federal Vaccine Mandates, Updated CDC Guidance on Pre-Vaccine Risks and Post-Vaccine Reactions Related to Administering mRNA Vaccines Added to AAAAI COVID-19 Resources PageThese CMS interim final rules recently released do not apply to physicians' practices if they are not directly regulated by CMS. Physicians may face other requirements if they are on the staff of an acute care hospital. The OSHA rules also do not apply, but physicians' offices may already be covered by the OSHA Emergency Temporary Standard (ETS) that went into effect in January of 2021. A summary of these rules has been posted to the AAAAI COVID-19 resources page.

The AAAAI COVID-19 resources page also describes how the CDC recently updated their guidance on administration of the SARS-CoV-2 mRNA vaccines with respect to pre-vaccine risks and post-vaccine reactions. You can read more on our Vaccine Reactions page.

Vaccine Boosters in Older PatientsThis study from Israel on 97 healthcare workers and/or family members aged 60 years and older found that a booster dose of Pfizer vaccine increased IgG anti-spike antibody titers from a mean of 440 AU/ml (AU = arbitrary units) to 25,468 AU/ml 10-19 days after the booster dose. No correlation was observed between age and IgG titers, but the mean age of patient was 70 years (so narrow age range). Age, sex, presence of comorbidities and days after first vaccination was not associated with higher IgG titers.

Counseling Parents of Our Pediatric Patients About VaccinationThis editorial from JAMA presents useful information about pediatric vaccination. “Severe illness has been uncommon among the more than 6 million children who have tested positive for SARS-CoV-2. Depending on the state, 0.1% to 2.0% and 0.00% to 0.03% of pediatric COVID-19 cases resulted in hospitalization and death, respectively. As of October 4, 2021, a total of 5,217 cases of multisystem inflammatory syndrome in children (MIS-C) and 46 MIS-C deaths have been reported. The risk of severe illness and death is greater for children older than 10 years. Although the percentage of severe illness among pediatric cases is small, as infections increase, so too will the number of children who become seriously ill. At least 1.9 million children aged 5 to 11 years have been infected with SARS-CoV-2 and more than 8,300 of them have been hospitalized, a third of whom needed intensive care. Nearly 100 children aged 5 to 11 years have died, making COVID-19 among the leading causes of death in this age group. Hospitalization rates among children aged 5 to 11 years are 3 times higher for Black, Hispanic, or Native American children than for White children, with rates of 45 to 50 per 100,000 children vs 15 per 100,000 children, respectively. Data from adolescents suggest that BNT162b2 vaccinations for children 5 to 11 years old will likely prevent most hospitalizations and deaths.”

Details concerning the CDC assessment of vaccines for children ages 5-11 can be found here.

Delayed Angioedema After mRNA VaccineThis group from Northwestern reports three patients with angioedema that presented a mean of 39 hours after the vaccine and involved the airway in all three. They were all treated with epinephrine and steroids, and resolved within 24 hours. Serum tryptase was normal. One of the three received a second dose of the same vaccine 6 months later without any reaction.

AAAAI Podcast on COVID-19 Vaccination During PregnancyThis podcast episode (#59), featuring Jennifer Namazy, MD, FAAAAI, is now available for free on the AAAAI websiteApple or Google Podcasts, and Spotify.

Infection

U.S. Cases Plateau But European Cases IncreasingAccording to data from Johns Hopkins, cases in Europe are increasing exponentially, a potential bellwether for the near future for the United States. Europe has a higher vaccination rate than the United States. Currently the wave in Europe is being driven by all age groups. Get those boosters!

NIH Tool to Help Individuals on When to TestOn November 3, the NIH announced a tool to help individuals determine if they are at risk of getting or transmitting COVID-19, and whether and when they should be tested. The calculator includes answers to frequently asked questions and links both to resources on testing strategies and on obtaining supplies, including home tests. The test is simple, has only a few prompts and can be found at whentotest.org.

Treatment

Regeron Announces Long-Lasting Effect of COVID-19 Monoclonal AntibodyOn November 8, Regeneron announced additional results from a Phase 3 study, done jointly with the NIAID, on 1,683 uninfected, high-risk patients treated pre- or post-exposure with monoclonal antibody or placebo during months 2-8 of follow-up. There was an 81.6% reduced risk of developing COVID-19 during this time, and zero treated patients were hospitalized, compared to six in the placebo group. Vaccination was allowed after the first month, but was balanced between the treatment and placebo group. These results have not been published or peer-reviewed, but details of the study are available in the press release.

Pfizer Announces a New Anti-Viral Oral Treatment for COVID-19On November 5, Pfizer announced that its antiviral drug Paxlovid when given to high-risk infected patients within 3 days of symptom onset was 89% effective in reducing the risk of hospitalization and death (three hospitalizations and zero deaths in treated group vs. 27 hospitalizations and seven deaths in the placebo group). The study involved a total of 774 patients. The results of the clinical trial have not been peer-reviewed or published.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAIChair of the AAAAI COVID-19 Response Task Force


Wednesday, November 3, 2021

The Centers for Disease Control and Prevention (CDC) Tuesday recommended giving the Pfizer-BioNTech COVID-19 vaccine to children ages 5- to 11-years-old beginning as early as today (Wednesday, November 3, 2021).  

The recommendation follows a unanimous vote earlier in the day by the CDC’s Advisory Committee on Immunization Practices (ACIP) to recommend the vaccine under the FDA’s Emergency Use Authorization. 

The vaccine will be administered as a primary series of 2 doses 3 weeks apart. The dose is one-third of that given to adults and adolescents (10mcg vs. 30mcg).

Allergists should encourage their patients in this age group to contact their primary care physicians now to get on the list for vaccination. Doses have already been delivered to many states, if not all.

During a daylong meeting Tuesday, the ACIP was presented with robust data on efficacy and safety of the vaccine in this age group. They also heard presentations on the rapid rise in cases among children, as well as data on vaccine-associated Myocarditis

To date, there have been at least 1.9 million COVID-19 cases in the 5-11 age group, including 8,300 hospitalizations and 84 deaths, according to CDC data. You can find all of the presentations from Tuesday’s meeting here

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page for regular updates and information that can help you advise parents and your patients about the vaccine.  


Monday, November 1, 2021

Here are today's important updates:

Public Health Emergency (PHE)

HHS Extends the PHE Until January 18This means that the telehealth waivers will remain in effect and many insurers are extending their coverage allowances, but not all. Be sure and check with the patient’s carrier before COVID-19 vaccination, viral testing, antibody testing or monoclonal antibody therapy.

Vaccines

CDC Recommendation for a "Booster Dose" for Moderate to Severe ImmunocompromisedWe know about the “additional dose” for this group of people, but the CDC just updated information on a booster dose for this group. Moderately and severely immunocompromised people aged 18 years and older who completed an mRNA COVID-19 vaccine primary series and received an additional mRNA vaccine dose may receive a single COVID-19 booster dose (Pfizer-BioNTech, Moderna, or Janssen) at least 6 months after completing their third mRNA vaccine dose. In such situations, people who are moderately and severely immunocompromised may receive a total of four COVID-19 vaccine doses. A person who is moderately or severely immunocompromised and has received two doses of an mRNA vaccine and at least 28 days has elapsed since the second dose, should receive an additional mRNA dose immediately* (if Moderna COVID-19 vaccine is used, administer 100µg in 0.5ml), followed at least 6 months later by a single COVID-19 vaccine booster dose (if Moderna vaccine booster is used, administer 50µg in 0.25ml). 

Vaccine Effectiveness Against Hospitalization in Adolescentscase-control study involving 464 patients 12-18 years in 19 pediatric hospitals from June-September 2021 found that vaccination reduced risk for hospitalization by 93%. Of adolescents that were hospitalized for COVID-19, 97% were unvaccinated, and no vaccinated adolescents hospitalized with COVID-19 were admitted to the ICU. Since adolescents are lagging behind other groups in vaccination, this information might be helpful in discussing it with them or their parents. 

Vaccines for ChildrenThe FDA’s Vaccines and Related Biologics Advisory Committee (VRBAC) voted unanimously with one abstention to recommend Pfizer’s mRNA vaccine for children ages 5-11 at 1/3 the normal dose. Moderna’s application for approval for children ages 12-18 is still pending. The FDA followed VRBAC’s recommendation and granted an emergency use authorization on October 29. The ACIP will be meeting November 2-3 to discuss children and adolescent vaccines for COVID-19. This meeting will be open to the public here. Interestingly, pediatric doses are already being delivered to states in anticipation of approval.

Vaccine ReactionsEvidence from a prospective vaccine registry study in a single large health system found that of 113 patients with a history of reactions to the first dose of an mRNA vaccine, 86.7% tolerated the second dose when given under allergy clinic observation with antihistamine pre-treatment, and that PEG testing and challenges were not helpful, with a large number of false positives. Testing to the vaccine was not performed because the FDA required an IND for this and the companies would not provide vaccine. This included 4/5 with a history of anaphylaxis. This is one of a number of small studies on patients with allergic reactions to mRNA vaccines who have gone on to have subsequent vaccination with the same vaccine with tolerance. Testing to PEG has also not been helpful in a number of studies. 

In a second study reported in the same journal, a group from Michigan reported a retrospective study of 66 patients with alleged allergic reactions to their first vaccine (only one with anaphylaxis) and 80% successfully received their second vaccine

In another cohort study of 52,998 healthcare workers at the Massachusetts General Brigham Health System, self-reported high-risk allergy history was associated with an increased risk of self-reported allergic reactions after mRNA COVID-19 vaccination (adjusted Relative Risk 2.46; 95% CI, 1.92-3.16) with risk being highest for hives and angioedema. “However, following the CDC guidelines, with allergist consultation, risk stratification, and shared decision-making, all employees were able to complete the 2-dose vaccine series.” 

COVID-19 Hospital Admissions and Deaths After Vaccination 
We are hearing a lot about breakthrough infections, hospitalizations and death in vaccinated individuals, often as an excuse to not get the vaccine. This prospective study from Scotland who followed 2,572,008 individuals who had received their first dose of vaccine between December 2020 and April 2021 (32.7% received Pfizer, 67.3% AstraZeneca). 694,915 received a second vaccine dose during the study period (59.4% Pfizer). 1,196 (<0.1%) were hospitalized or died (883 hospitalized, 228 of these died, and 313 died without being hospitalized). Factors associated with severe disease were older age (>79), comorbidities, high-risk occupations, care home residence, socioeconomic deprivation, being male and being an ex-smoker, in that order. It is important to note that only 1/3 of this group received an mRNA vaccine, and most had not received a second dose. The rate of severe outcomes was similar for the two vaccines, however. 

Vaccinated Less Likely to Be Hospitalized With Subsequent COVID-19 Compared to Previously Infected People Data from nine states showed that among COVID-19-like illness hospitalizations among adults aged 18 years and older whose previous infection or vaccination occurred 90 to 179 days earlier, the adjusted odds of laboratory-confirmed COVID-19 among unvaccinated adults with previous SARS-CoV-2 infection were 5.49-fold higher than the odds among fully vaccinated recipients of an mRNA COVID-19 vaccine who had no previous documented infection (95% CI = 2.75-10.99). 

Lower Risk of Non-COVID Death After VaccinationThere have been reports of death after COVID-19 vaccination on the VAERS website, and much disinformation on social media regarding the same. In a study of 11,000,000 patients enrolled in the Vaccine Safety Datalink (VSD) researchers found that the rate of non-COVID deaths were over 65% lower in those vaccinated compared to those who were not vaccinated. This reinforces the safety of the vaccinations and adds to an earlier study that showed a similar reduction in mortality in nursing home residents.

Booster Provides Higher Antibody Response Which Is Sustained Researchers from the Vaccine Research Center of the NIAID with collaborators from Emory, Hopkins, Moderna and Bioqual studied booster doses of Moderna vaccine in Rhesus macaques and found the antibody response to be higher than after the primary series, sustained for at least 8 weeks, and were protective against all variants of concern. This study was focused on the Beta variant, which is more resistant to neutralization than the current Delta variant. 

Vaccinated Less Likely to Be Infected With Household Contacts But Just As Likely to Spread Disease This study confirms earlier findings. Fully vaccinated individuals who are infected are equally likely to spread the infection among household contacts as unvaccinated household members, but are less likely to be infected by other household members. Fully vaccinated had a faster reduction in viral load. 

Infection

CDC Data Tracker Now Reporting Rates of COVID-19 Cases, Hospitalizations and Death By Vaccinations Status Visit this page.

Delta Plus: Is It Important?Cases of COVID-19 have been increasing in the United Kingdom lately, with the current peak higher than during the earlier Delta peak. Some have been blaming this on the AY.4.2 Delta mutant strain that is currently present in about 10% of U.K. sequenced samples. This mutation is only 10-15% more transmissible than the original Delta, and appears to be susceptible to the current vaccines. This mutation is present in the United States, but makes up <0.5% of variants

Does the Delta Variant Cause More Severe Disease?It is well established that the Delta variant is more transmissible, but there is some disagreement on disease severity. Analysis of COVID-NET data from 14 states during the period of Delta predominance did not indicate an increase in the proportion of hospitalized patients with severe outcomes. The proportion of hospitalized unvaccinated persons ages 18-49 did increase significantly during this period. 

No Increased Risk in EoE PatientsInformation from a global registry of EOE and EGID patients published online in JACI: In Practice suggests that these patients are at no more risk for severe disease than the general population. 

Residual Cognitive Effects CommonIn this case-control prospective cohort study in patients within the Mount Sinai Health System in patients with mild to severe disease, 18-25% had cognitive deficits at a mean of 7.6 months after infection. The most prominent deficits were in processing speed (18%, n=133), executive functioning (16%, n=118), phonemic fluency (15%, n=111) and category fluency (20%, n=148), memory encoding (24%, n=178), and memory recall (23%, n=170). Mean age of the population was 49 years

Treatment

Antidepressant Reduces Risk of Hospitalization for COVID-19In case your patients mention this: A multi-center randomized, placebo-controlled, adaptive platform blinded trial in Brazil involved almost 1,500 high-risk patients. Those treated with fluvoxamine, an SSRI anti-depressant, 100mg twice daily for 10 days were less likely to be hospitalized (11% vs. 16%, RR 0.68, 95% CI 0.52-0.88).

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAIChair of the AAAAI COVID-19 Response Task Force


Friday, October 22, 2021

The Centers for Disease Control and Prevention (CDC) Thursday night expanded its recommendations for COVID-19 vaccine booster shots for certain populations to include the Moderna and Janssen (Johnson & Johnson) vaccines. The recommendation followed the CDC’s Advisory Committee on Immunization Practices (ACIP) endorsement of the boosters earlier in the day. The FDA granted Emergency Use Authorization of the boosters Wednesday.

The CDC also said eligible people can “mix and match” and choose to receive a booster vaccine that is different from the one they received for their initial series.

The recommendations call for:

  • A single COVID-19 vaccine booster dose at least six months after completion of an mRNA primary series for certain populations. The dose for the Moderna booster would be half that given during the primary series. The booster is recommended for individuals in the same risk groups identified when the Pfizer-BiNTech vaccine was approved last month, including those who are:
  • The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine at least two months after completion of the single-dose primary regimen to anyone 18 years of age and older. The dose would be the same as the primary dose.

In making its recommendation, the advisory panel stressed that people who have received two mRNA vaccine doses or a single Johnson & Johnson dose should still consider themselves fully vaccinated. Federal health officials said they would continue to study whether those who had weak immune systems and had already received a third dose of a vaccine should go on to get a booster shot.

Clinician Outreach and Communication Activity (COCA) will host a webinar on Tuesday, October 26 intended to give clinicians an overview of the most recent recommendations for administering COVID-19 booster vaccines.

The AAAAI COVID Resources page continues to be updated to provide you with resources and advice to provide optimal care to your patients during this time.


Monday, October 18, 2021

Here are today's important updates:

Vaccines

COVID-19 Breakthrough Infections in Healthcare Workers (HCW)
This case-control study from Israel involving 1,497 fully vaccinated HCWs documented 39 COVID-19 breakthrough infections (2.6%). Neutralizing antibody titers were lower in case patients (case-control ratio 0.361; 95% CI, 0.165-0.787). Higher peri-infection titers were associated with lower infectivity as measured by RT/PCR Ct values. Most cases were mild or asymptomatic, but 19% had symptoms that persisted for more than 6 weeks. Alpha variant was found in 85% of sequenced samples. 

FDA Advisory Committee Meets to Review Authorization for Booster for Moderna, J&J and Pfizer Application for Ages 5-11
The Vaccines and Related Biologics Advisory Committee (VRBPAC) met on October 14 and 15 and unaniminously recommended that Moderna be granted an EUA for a booster dose after 6 months for those 65 years of age and older, as well as 18-64 year-olds with risk of severe infection or high exposure, so essentially the same as Pfizer’s criteria. The recommended dose is 1/2 the dose (50mcg or 2.5cc) used in the primary series. They also recommended a second dose of the J&J vaccine for all recipients at least 2 months after the first dose. The FDA will need to consider the Advisory Committee’s recommendation and rule on it. The CDC's ACIP will meet to discuss this on October 20 and 21 with possible approval shortly after. VRBPAC will meet again on October 26 from 8:30 am to 5:00 pm ET to discuss Pfizer’s application for vaccine for 5-11 year-olds.

Real World Data on Myocarditis After mRNA Vaccines
This retrospective study from a large healthcare system in California on 2,393,924 patients who had received at least one dose of an mRNA vaccine noted an observed incidence of 0.8 cases per million after the first dose and 5.8 cases per million after the second dose, all occurring in males with median age of 25. This compares to 1.8 cases per million in controls, 52% in men, with a median age of 52. Most cases were mild and resolved with conservative management. 

Mix and Match Vaccine Effect
Media reports have highlighted the initial press releases surrounding an NIH study evaluating the effect on antibody production following booster doses of J&J, Pfizer and Moderna vaccines after initial dosing with J&J. The study has not been peer-reviewed and there has not been any official review by the FDA as of yet, so recommendations surrounding mixing different vaccines for booster doses are still forthcoming. 

Review Our Ask the AAAAI About COVID-19 Section 

A reminder that the AAAAI COVID-19 resources page includes an Ask the AAAAI About COVID-19 section where answers to member questions on vaccinesimmunocompromised patients and more are being posted. Have a question that has not been answered? Email it to practicematters@aaaai.org.

Transmission

Previous Infection or Complete Vaccination Offer Protection Against Family Member Disease
This cohort study of 1,789,728 individuals from 814,806 families in Sweden showed that the presence of one family member with either previous COVID-19 infection or complete vaccination was associated with a 45-61% reduced risk of contracting COVID-19. Risk reduction increased to 75-86% in families with two immune members, and 91-94% with three immune family members. Take home message: For the protection of vulnerable family members, it is important to immunize as many members of the household that are eligible for vaccination. 

Infection Risk Similar Between Children and Adults
cohort study of 1,236 participants in 310 households in Utah and New York City found that the incidence rates for infection with COVID-19 were similar in children and adults. Children were much less likely to be symptomatic than adults (50% versus 88%), but household transmission was 44% in Utah and 80% in New York City. With approval for pediatric vaccines likely in the next few weeks, parents will be asking our advice on whether their children should be vaccinated. Pediatric hospitalization rates are increasing with the Delta variant, asymptomatic children can transmit disease, and even though children are less likely to have severe disease, infection is likely to increase the risk for the development of variants of concern. Two editorials (here and here) accompanied the publication of this study. 

Multicomponent Strategies to Prevent COVID-19
Although this study was done in summer camps, the implications apply to other congregate settings, such as schools. During June-August 2021, among 7,173 campers and staff in nine overnight camps that utilized high vaccination coverage (93% of those eligible vaccinated), prearrival and frequent screening testing, cohorting, masking and physical distancing, there were nine cases of COVID-19. In contrast, in Louisiana summer camps this past summer, where Delta was dominant and transmission was high, there were 321 camp-associated cases among 2,988 campers and staff. Most were not vaccinated and only one of 28 camps required indoor masking. 

Infection

Latest on Long-term Post-Acute Sequelae of COVID-19 Infection (PASC)
This systematic review of 57 studies comprising more than 250,000 survivors of COVID-19 provides evidence that PASC affects 55% of survivors 6 months or more after infection. The most common sequelae included mental health, pulmonary and neurological disorders. It should be noted that 79% of the patients in these studies had been hospitalized with COVID-19. 

Treatment

Merck Applies for Approval of Oral Therapy  
Merck has applied to the FDA for approval for the first oral antiviral treatment for COVID-19. The treatment, molnupiravir, is given as four capsules twice daily for 5 days in patients with symptoms of COVID-19 within the last 5 days and who are at high risk for severe disease. Clinical trials of this agent have shown a 50% reduction in hospitalizations and death from COVID-19.

Monoclonal Antibody Treatment Criteria 
The NIH COVID-19 Treatment Guidelines Panel updated their recommendation for monoclonal antibody treatment on October 7, to reflect current supply constraints. Unvaccinated patients with COVID-19 should be prioritized to receive monoclonal antibodies. Pre-exposure prophylaxis is a lower priority when supply of product is inadequate. 

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, October 4, 2021

Here are today's important updates:

Vaccines

Reaction to Booster Doses of Pfizer Vaccine Similar to Reactions After the Second Dose 
During August 12-September 19, 2021, among 12,591 v-safe registrants who completed a health check-in survey after all three doses of an mRNA COVID-19 vaccine, 79.4% and 74.1% reported local or systemic reactions, respectively, after the third dose; 77.6% and 76.5% reported local or systemic reactions after the second dose, respectively. So far there is no evidence for increased cases of myocarditis, but only 22,000+ responses have been logged to date.

Possible Mechanism of Allergic Reaction
In this small but interesting study, researchers from Stanford studied 22 patients with a suspected history of an allergic reaction to an mRNA vaccine with skin tests to PEG, polysorbate 80 (P80) and the vaccine which they were given, as well as basophil activation testing (BAT) to the same antigens, and IgG and IgE to PEG. Seventeen out of 22 patients fulfilled the Brighton Criteria for anaphylaxis. None had positive skin tests to PEG or P80, and one had a positive skin test to the vaccine. Ten out of 11 had a positive BAT to PEG, and 11 out of 11 had a positive BAT to their vaccine. None had anti-PEG IgE, but all had anti-PEG IgG. Only one of the patients had received a second dose of the same vaccine, with a subsequent more severe reaction. That patient’s skin tests were negative, but skin testing reproduced the symptoms. Clearly more data is needed, but this might suggest that the anaphylactic reactions that are occurring are mediated by IgG.

CDC Urges Vaccine for Pregnant and Women of Childbearing Age
Released on September 29 from the CDC Health Alert Network, “the Centers for Disease Control and Prevention (CDC) recommends urgent action to increase Coronavirus Disease 2019 (COVID-19) vaccination among people who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future.” As of September 27, 2021, more than 125,000 laboratory-confirmed COVID-19 cases have been reported in pregnant people, including more than 22,000 hospitalized cases and 161 deaths. This doesn’t directly apply to the practice of allergy, but we can add this as another reason to encourage vaccination in our female patients.

Immunology of COVID-19 Infection

Anti-Interferon (IFN) Antibodies Tied to Severity
Researchers from the international COVID Human Genetic Effort have found that 20% of people hospitalized with severe COVID-19 had high or intermediate levels of autoantibodies to Type 1 IFNs, whereas people with mild disease and uninfected controls had very low levels of these autoantibodies. The level was also associated with age. Most with high levels were over 40. The study involved 3,500 people with severe or fatal disease and 34,000 uninfected volunteers. Testing for these autoantibodies in the future could help identify uninfected people who need aggressive preventive measures or infected people who need early aggressive treatment.

Testing

Interpreting SARS-CoV-2 Test Results
This article presents a concise and brief case-based discussion on testing which is helpful for the clinician.

Test Frequency and Turnaround Time More Important Than Sensitivity
We know that antigen testing has a lower sensitivity than RT-PCR for the diagnosis of COVID-19, particularly in asymptomatic people. Using modeling, this paper found little difference in averting infectiousness between frequent antigen testing (daily to every third day) and RT-PCR, and that testing frequency was found to be the primary driver of population-level epidemic control with only a small margin of improvement by using a more sensitive test. Delays in result reporting was a major factor in their analysis.

Infection

1 Year Outcomes in Hospital Survivors
This study from China looked at 1,276 hospitalized COVID-19 survivors at 6 months and 12 months post-discharge. The proportion of patients with at least one symptom declined from 68% at 6 months to 49% at 12 months, but the proportion of patients with dyspnea increased from 26% to 30%. Women appeared to be more affected than men. Spirometry was normal in most, but diffusion capacity was reduced in 23% at 12 months. Of the small number with CT scans (28), 39% still has at least one abnormality.

Masking and Prevention of School Outbreaks
A study from the CDC showed that based on county level data, after controlling for covariates, school mask requirements remained associated with lower daily case rates of pediatric COVID-19 (ß = -1.31; 95% confidence interval = -1.51 to -1.11) (p<0.001). Another CDC study done in Maricopa and Pima counties in Arizona found that schools without mask requirements were 3.5 times more likely to have COVID-19 outbreaks compared to schools that started the year with mask requirements.

Treatment

Inhaled Budesonide Treatment in Early COVID-19
This open-label, parallel-group randomized controlled trial in 139 people with early COVID-19 symptoms found that inhaled budesonide 800mcg twice daily started within 7 days of symptom-onset and continued until symptoms were resolved, resulted in a marked reduction in the need for an urgent care visit, ER or hospitalization, and reduced symptoms and symptom duration compared to usual care.

Monoclonal Antibodies to Prevent COVID-19
randomized, placebo controlled trial in over 1,500 patients 12 years of age or older who were treated with 1200mg of REGEN-COV subcutaneously within 96 hours of exposure to a household contact, found a relative risk reduction of 81.4% for symptomatic infection, 92.6% in weeks 2-4 after exposure, and an overall risk reduction for asymptomatic and symptomatic infection of 66.4%. There was also a 2 week shorter duration of symptoms in the treated group among symptomatic infected group.

Merck Seeks Authorization for New Antiviral Against SARS-CoV-2
An article in the New York Times reported that Merck will seek authorization for molnupiravir, which was shown in a clinical trial to reduce the risk for hospitalization or death by half if given to high-risk people early in the infection.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, September 20, 2021

Here are today's important updates:

Vaccines

Pfizer: Low Dose of Vaccine Safe and Effective in Children Ages 5 to 11 
Pfizer-BioNTech announced today that their studies show a 10 mcg dose (1/3 the adult dose) of their coronavirus vaccine results in a similar immune response to the higher dose in teens and adults. The companies plan to apply to the FDA by the end of the month for authorization to use the vaccine in these children. The findings have not yet been peer-reviewed nor published in a scientific journal.

Booster Doses – Yes/No – For Whom
On July 30, Israel approved a third (booster) dose of the Pfizer vaccine for people 60 years of age or older whose last vaccine dose was at least five months earlier. At least 12 days after the third dose, the rate of confirmed infection in the booster group was lower than the non-booster group by a factor of 11.3 (95% CI, 10.4-12.3); and the rate of severe illness was lower by a factor of 19.5 (95% CI, 12.9-29.5). Rates of infection at least 12 days after vaccination was lower by a factor of 5.4 compared to the rate after four to six days. On the other hand, a Viewpoint article written by several international experts including two scientists from the FDA’s Office of Vaccine Research and Review pointed out that the data supporting a third dose is preliminary and not very robust, and suggested that the vaccine focus should be on increasing the global number of people who have had at least one dose of a vaccine. These experts point out that the current variants causing the most problems (Delta and Gamma) both arose in countries with low vaccination rates. On September 17, the FDA Vaccine and Biologics Advisory Committee rejected Pfizer’s request to authorize a booster dose to all patients 16 years of age or older based on insufficient data but did approve a recommendation to authorize the vaccine booster for those over 65 years of age six months after the second dose and those at risk for severe infection. The full FDA, as well as the CDC and ACIP have to weigh in, and will probably meet this week.

Vaccine Effectiveness (VE) During Delta Predominance
This study examined the VE against infection, hospitalization and death before and during the period of Delta predominance. Across 13 U.S. jurisdictions, incidence rate ratios for hospitalization and death changed relatively little after the SARS-CoV-2 B.1.617.2 (Delta) variant reached predominance, suggesting high, continued vaccine effectiveness against severe COVID-19. Case IRRs decreased, suggesting reduced vaccine effectiveness for prevention of SARS-CoV-2 infections. Fully vaccinated people had five times lower risk of infection, and over 10 times lower risk for hospitalization and death compared to those not fully vaccinated. 

Using a different cohort among nine states which included several large health systems, during June through August of this year, VE against hospitalization was 86% (89% 18-74 years old vs. 76% for 75 and older)( Moderna 95% VE vs. 80% for Pfizer and 60% for J&J). VE for ER/Urgent Care visits was 82% overall (92% for Moderna, 77% for Pfizer, 66% for J&J). Data from the same health systems from January to June showed a VE of 89% against hospitalization, 90% against ICU admission and 91% against ER or Urgent Care visits. Finally, data from five VA Medical Centers from February to August showed similar results. Vaccine effectiveness in preventing COVID-19–related hospitalization was 80% among adults aged 65 years and older compared with 95% among adults aged 18–64 years.

ER Visits and Hospitalizations in Pediatrics
While the general impression among the public is that COVID-19 infections are milder in children, a recent report indicated how significant these infections really are, and that vaccines are effective in reducing severe disease even in children. This study demonstrated that ER visits and hospitalizations are four times greater in areas with low vaccine coverage compared to those with high vaccine coverage.  

Vaccination Reduces Household Transmission in Health Care Workers
This study from Scotland involved a large number of health care workers and their household members. The rate of household transmission was significantly lower after vaccination compared to the time prior to vaccination, suggesting that the vaccine may reduce transmission.

Additional Safety Information
Most of the reports on safety issues with the mRNA vaccines come from the Vaccine Adverse Events Reporting System (VAERS) which has significant limitations as previously discussed. This study used data from the Vaccine Safety Datalink which uses data entered on a regular basis on patients of several large health systems. The analysis included surveillance data on 6.2 million people who had received 11.8 million doses of mRNA vaccines and found no significant increase in 23 serious health care outcomes that had been followed during the clinical trials on the vaccines in the first 21 days after a vaccine dose, compared to matched patients with vaccination 22-42 days prior. Incidence of confirmed anaphylaxis was 4.8 per 1,000,000 doses. In an accompanying editorial, Kimberly G. Blumenthal, MD, MSc, FAAAAI, current Secretary of the AAAAI's ADDA Interest Section, and others further emphasize the findings of the study and do note that the risk for myocarditis/pericarditis was not significant overall. It was elevated in the 12-39 year old age group with an estimated 6.3 (95% CI, 4.9 to 6.8) additional cases per million doses in days zero through seven after vaccination. 

Vaccine Response in Stem Cell Transplant Patients
Results from a single center study of 117 patients with a previous allogeneic hematopoietic stem cell transplant without previous COVID-19 infection and no active graft vs. host disease showed that 83% of patients had an antibody response after the second dose of the Pfizer vaccine, with 62% of the group having similar titers to healthy vaccine recipients. Factors associated with an absence of response included a haplotransplant, recent (<1yr) HSCT, lymphopenia (<1000 cells/microliter) and receipt of immunosuppressive treatment at the time of the vaccination. This study was limited to antibody response, and did not evaluate T cell response.    

SARS-CoV-2

What About The “MU” (B.1.621) Variant?
This is currently considered a Variant of Interest (VOI) by the WHO, but has not been classified as such by the CDC at this time. It is present in most states, reached its peak in June and is declining since then, now representing 0.1% of all isolates. It is increasing in South America, with 39% of isolates in Colombia. It is of interest because of three mutations (in addition to the usual suspects) that affect the binding sites for monoclonal antibodies, antivirals and, perhaps more importantly, one on a location that inhibits B- and T-cell recognition. This was first discovered in Colombia and is another example of the importance of global vaccinations. 


Practice

Does Mandatory Vaccination of All Staff Apply to Your Practice?
In short, we don’t know yet. The Biden Administration announced that it "will require COVID-19 vaccination of staff within all Medicare and Medicaid-certified facilities.” Whether the typical allergy office is a “facility” as defined by CMS is not clear, and will be further defined in the development of the regulatory process. If you practice in a Federally Qualified Health Center or Rural Health Clinic or provide services under an arrangement with such a facility, then it will likely apply. Check in later messaging or the AAAAI COVID-19 Resource page for future developments.

Provider Relief Fund (PRF) Updates
HHS announced on September 16 a final 60 day grace period to help providers if they fail to meet the September 30 deadline for the first PRF Reporting Time Period. No collection activities or enforcement activities will occur during this time. HHS has completely revamped the PRF website and updated the FAQsQuestions relate to returning payments, period of time in which providers must use the payments, details on reporting of expenditures, audit extensions, eligible capital facility expenditures, and calculation of lost revenues. HHS announced it will make another $25.5 billion available to providers. This includes $8.5B for health care providers (HCPs) who serve rural Medicaid, CHIP or Medicare patients and $17B for a PRF Phase 4. PRF Phase 4 will reimburse smaller providers for their lost revenues and COVID-19 expenses at a higher rate compared to larger providers and will also include bonuses for those who serve Medicaid, CHIP and/or Medicare patients. Providers can apply for both programs in a single application. The application portal will open on September 29. 

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, September 7, 2021

Here are today's important updates:

Vaccines

AAAAI Primary Immunodeficiency Committee Offers Advice on Who Needs an Additional Dose of the mRNA Vaccines
The AAAAI Primary Immunodeficiency (PIDD) Committee has reviewed available evidence on SARS-CoV-2 vaccine responses in patients with inborn errors of immunity (IEI), and acknowledges that information regarding the types of IEI that represent higher risk of either severe COVID-19 and/or suboptimal response to current SARS-CoV-2 vaccinations is still emerging. The AAAAI PIDD Committee endorses the third dose for people with immune deficiencies as it believes most patients will benefit from the extra dose. However, the timing and specifics should be discussed with one’s own immunologist.

Vaccine Effectiveness (VE) in Frontline Workers Before and After Delta Predominance
During December 14, 2020-April 10, 2021, data from the HEROES-RECOVER Cohorts, a network of prospective cohorts among frontline workers, showed that the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines were approximately 90% effective in preventing symptomatic and asymptomatic infection with SARS-CoV-2 in real-world conditions. This report updates the VE estimates through August 14. Adjusted VE during Delta variant predominance (>50% of strains sequenced) was 66% (95% CI 26-84%), with a trend (not significant) toward lower VE in those with >150 days since completion of full vaccination. During this period, of those infected, 75% of the vaccinated were symptomatic versus 94.7% of the unvaccinated.

ACIP Meeting on August 30 and FDA Advisory Committee Meeting on September 17
At its August 30 meeting, the ACIP reaffirmed the FDA’s full approval for the Pfizer vaccine after reviewing the safety and efficacy data, and reaffirmed that the benefits outweigh the risks for vaccination. Data reviewed indicate that the rate of anaphylaxis after vaccination remains extremely low (5.0 per 1,000,000 doses), and that myocarditis is increased after mRNA vaccination, but cases are mostly mild and much less than with COVID-19 infection. They did not vote on booster doses, but shared information on continued vaccine effectiveness against severe disease and death. The ACIP will meet again in mid-September to discuss additional data on boosters. View the slides from this meeting.

The FDA’s Vaccine and Biological Products Advisory Committee will meet on September 17 from 8:30 am to 3:35 pm ET to discuss the Pfizer application for a booster dose. Here is the link to attend.

Infections and Hospitalizations By Vaccination Status
During May-July 25, 2021, among 43,127 SARS-CoV-2 infections in residents of Los Angeles County, Calfornia, 25.3% were in fully vaccinated persons, 3.3% in partially vaccinated persons, and 71.4% in unvaccinated persons. On July 25, infection and hospitalization rates among unvaccinated persons were 4.9 and 29.2 times, respectively, those in fully vaccinated persons.

Safety of the Pfizer Vaccine in a Nationwide Setting
This study from Israel examined adverse events in 884,828 matched vaccinated and unvaccinated persons and found an increased risk of myocarditis [risk difference (RD) 2.7 events per 100,000], lymphadenopathy (RD 78.4 events per 100,000), appendicitis (RD 5.0 events per 100,000) and herpes zoster infection (RD 15.8 events per 100,000). The risk of myocarditis from SARS-CoV-2 infection was six times higher than from vaccination.

Allergic Reactions to the Pfizer Vaccine
This cohort study from Israel involves 8,102 individuals with an allergy history. Using a detailed questionnaire, those with a history of prior anaphylactic reaction to any drug or vaccine, multiple drug allergies, multiple allergies, or mast cell disorders were considered high risk and vaccinated under medical supervision by a dedicated allergy team. Of the 429 individuals who were considered highly allergic, 97.9% had no reaction after the first dose, 1.4% developed minor allergic reactions, and 0.7% had anaphylactic reactions. Among the 281 who had a second dose during the study, 98.2% had no reaction, 1.8% had minor reactions and there were no anaphylactic reactions. This study reaffirms the safety of this vaccine and brings into question whether any screening is needed before vaccination.

FDA and AAP Warn Against Off-Label Use of the Pfizer Vaccine
There have been a significant number of children in the United States younger than 12 years who have been given this vaccine. Both the FDA and the AAP strongly advise against this. Studies are currently ongoing to determine the proper dose and to evaluate the response. Giving this vaccine off-label could threaten your liability protection.

NIH Launches Study of Additional Vaccine Dose in Patients With Autoimmune Disease
The NIH has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen. The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population. The Phase 2 trial is sponsored and funded by the NIAID, part of NIH, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence.

Transmission

Delta Variant May Cause More Severe Disease
This cohort study published in Lancet Infectious Diseases on August 27 showed that the risk for hospitalization was about 45% greater with the Delta variant compared to the Alpha variant. This supports evidence presented earlier from Scotland where risk was 85% greater, and also involved younger people. 70% of the admissions were not associated with a comorbid condition.

Hospitalization Among Children and Adolescents
Weekly COVID-19-associated hospitalization rates among children and adolescents rose nearly five-fold during late June to mid-August 2021, coinciding with increased circulation of the highly transmissible SARS-CoV-2 Delta variant. The proportions of hospitalized children and adolescents with severe disease were similar before and during the period of Delta predominance. Hospitalization rates were 10 times higher among unvaccinated than among fully vaccinated adolescents.

Importance of Vaccines and Masks in the School Setting
The CDC reported an outbreak in Marin County, California in May-June of 2021 associated with an unvaccinated, symptomatic elementary teacher who was periodically unmasked, where 55% of her students were subsequently infected. The secondary attack rate was 80% in the rows closest to the teacher. The school had high adherence to masks among the students, six foot separation of desks and increased ventilation.

Guides for Masks for Children
Now that it is back to school time, some of your patient’s parents may ask which mask is best for their child. There are good resources here and here.

Practice

Time to Review CDC Guidelines for Healthcare Workers
As the entire United States is now considered an area of high transmission of COVID-19, the chances of one of your staff being exposed to a patient with COVID-19 is much higher. This would be a good time to review the CDC's Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to SARS-CoV-2.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, August 23, 2021

Here are today's important updates:

Vaccines

FDA Grants Full Approval for Pfizer COVID-19 Vaccine for 16 Years and Older
The vaccine remains available under an EUA for 12-15 year-olds. Full approval for the 12-15 year-old patients remains a few months away.

FDA and CDC Advise Additional Dose of mRNA Vaccine
On August 12, the FDA amended the EUA for the Pfizer (for 12 years of age and older) and Moderna (for 18 years of age and older) vaccines to allow an additional dose for patients with moderate to severe immunosuppression or deficiency. This past week, the AAAAI sent a blast email to membership outlining more specifics about who that includes. This dose is called an “additional” dose and not a “booster,” as the latter term is reserved for those who had an adequate initial response which is waning over time. Since most allergist offices are not administering COVID-19 vaccines, you can inform your patients that they can get this at the pharmacy by attesting that they have such an immune deficiency (no proof needed) or you can communicate this to their primary physician if they are administering the vaccines. The additional dose should be given at least 28 days after the second dose, and should match the vaccine used in the primary series. In the rare instance that this is not possible, heterologous dosing is allowed (but only with the other mRNA vaccine). So far the data is insufficient concerning the J & J vaccine. Effective August 12, CMS will pay to administer additional doses of COVID-19 vaccines consistent with the FDA EUAs, using CPT code 0003A for the Pfizer vaccine and CPT code 0013A for the Moderna vaccine. They will pay the same amount to administer this additional dose as they did for other doses of the COVID-19 vaccine (approximately $40 each).

Booster Doses of mRNA Vaccines for All Likely to Begin September 20
Several news agencies reported on August 18 that the White House will announce booster doses of the mRNA vaccines would be authorized for all patients who completed their primary vaccine series 8 or more months ago. Although booster doses have not been approved yet by the FDA or CDC, heads of both agencies signed onto the announcement. The initial doses would be directed to healthcare workers, those over age 65 and residents of skilled nursing facilities and nursing homes. Data from the CMS-approved care facilities over the time period before and after the Delta variant became predominant show a progressive decline in vaccine effectiveness (VE) from 74.7% to 53.1%. This analysis could not distinguish between asymptomatic and symptomatic infection. Data from New York state showed a similar decline in age-adjusted VE from May 3-July 25 from 91.7% to 79.8% for any infection. The rate of infection in unvaccinated people was approximately 10 times the rate in vaccinated. Protection against hospitalization, on the other hand, was stable, from 91.9% to 95.3%. Data from 21 hospitals in 18 states from March to mid-July also showed VE against hospitalization remained steady for 24 weeks after vaccination (90% in immunocompetent adults).

Study Adds to Evidence That Previously Infected Benefit From Vaccination
Among Kentucky residents infected with SARS-CoV-2 in 2020, vaccination status of those reinfected during May-June 2021 was compared with that of residents who were not reinfected. In this case-control study, being unvaccinated was associated with 2.34 times the odds of reinfection compared with being fully vaccinated.

Half of Americans Fully Vaccinated
As of August 6, 165,918,256 people, or 50% of the total U.S. population, was fully vaccinated, while 182,368,493 or 70.6% of the adult population of the country had received one dose, according to the CDC. (Please note that the first figure reflects the entire U.S. population, while the second only the adult population.)

Vaccine Safety and Efficacy in Adolescents
Despite the earlier approval for the mRNA vaccines in adolescents, only a minority have received the vaccine. This update from the ongoing phase 2-3 placebo-controlled trial of the mRNA-1273 (Moderna) shows that local reactions (primarily injection site pain, swelling and erythema) occurred in 93.1% and 92.4% after the first and second dose respectively. 95% of these reactions were mild to moderate. Systemic reactions (headache, fatigue, chills were the most common) occurred in 68.5% and 86.1% respectively, with 85% being mild to moderate. Efficacy was similar to that in young adults. You can use this information to help convince your adolescent patients and their parents to consent to the vaccine. In another study, cardiologists report that in a small study of adolescents with myocarditis following the mRNA vaccine most tended to have a mild course, similar to young adults.

Vaccination Effects on Death and Dollars
This study estimated that by May 9, 2021, the U.S. vaccination campaign was associated with a reduction of 139,393 COVID-19 deaths. As of May 9, 2021, reductions in COVID-19 deaths associated with vaccines had translated to value of statistical life benefit ranging between $625 billion and $1.4 trillion.

Transmission

Pediatric Household Transmission of SARS-CoV-2 Infection
This study is particularly relevant as school reopens across the United States. It did take place prior to the dominance of the Delta variant. The study was done in Ontario, Canada and involved 6,280 households with pediatric index cases. 1,717 households (27.3%) experienced secondary transmission. The age group with the highest odds of transmitting the infection to household contacts compared with children aged 14-17 was the 0-3 year age group (1.43, 95% CI 1.17-1.75). Children in the 4-8 year age group also had a higher odds ratio (1.40, 95% CI 1.18-1.67). Since these age groups cannot be vaccinated, it is important for parents to take other precautions and be sure that the school or daycare is doing the same. As allergists who care for pediatric patients or young adults with children, we need to be aware of the family dynamics, childcare and school status in order to counsel our patients about prevention and precaution.

Treatment

Update on Monoclonal Antibodies
Current products that are available include casirivimab plus imdevimab (REGEN-COV) and sotrovimab. Current indications are for ambulatory adolescents and adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease. Treatment should be started ASAP and within 10 days of symptom onset. Casirivimab plus imdevimab can be administered IV or subcutaneously and have an expanded indication for post-exposure prophylaxis in individuals who are not fully vaccinated or are not expected to mount an adequate response to vaccination AND have been exposed to an infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting. Providers can directly order these medications from the distributor, AmerisourceBergen, although most will go through administration sites like hospital outpatient clinics. Details on dosing can be found on the NIH COVID-19 Treatment Guidelines page, and infusion sites close to your location can be found on the NICA Infusion Center Locator.

High-Titer Convalescent Plasma Not Effective
A randomized multi-center, placebo controlled single blind trial in 511 patients who presented to the ER for COVID-19 symptoms found that use of high-titer convalescent plasma was no better than placebo in preventing disease progression.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, August 9, 2021

Here are today's important updates:

Vaccines

NIAID/NIH Looking for Individuals With First Dose Allergic Reactions for Trial
The NIAID is looking for patients between the ages of 18-69 who experienced a systemic allergic reaction to the first dose of an mRNA vaccine for a clinical trial to study the safety of administering the second dose. Patients will be admitted to the ICU at the NIH and receive the second dose in a placebo-controlled crossover design. Patients will be compensated for their time, and travel to the NIH is covered. Interested people who qualify can contact the NIH Clinical Center Office of Patient Recruitment at (800) 411-1222 and refer to study #000460.

COVID-19 Vaccine Recommended for All Pregnant Women 
The American College of Obstetrics and Gynecology (ACOG) and the Society for Maternal and Fetal Medicine (SFMF) are now recommending that pregnant individuals be vaccinated against COVID-19. Allergists can use this information to reinforce vaccination for their pregnant asthmatics and allergic patients.

Second Dose of Vaccine Usually Tolerated in Those With Allergic Reactions to First
In this retrospective study from several different institutions involving 189 patients with a history of an allergic reaction after the first dose of mRNA vaccine, including 32 who met criteria for anaphylaxis, 159 patients (84%) tolerated a second dose, including 19 with first-dose anaphylaxis with mild reactions occurring in 32 (20%).

United States Reaches Vaccine Milestone
The United States now has 70% of adults with at least one dose of COVID-19 vaccine, a month past the July 4 goal set by President Joe Biden in May. The 70% goal is seen by federal health officials as a crucial step toward controlling the virus.

Booster Doses?
Germany, Israel and France are giving booster doses of vaccines for COVID-19 to immunocompromised patients, and Anthony Fauci, MD, FAAAAI, in a Reuters report stated that the United States would be joining them. In an article in the Wall Street Journal, the FDA will reportedly have a plan for booster doses in September. On the other hand, the New York Times quotes Paul Offit, MD, a member of the FDA Vaccine Advisory Committee, stating that the data submitted by Moderna and Pfizer does not support the need for boosters currently. For boosters to move forward either formal vaccine(s) approval by the Advisory Committee on Immunization Practices or amendment of the EUAs is required.

FDA Redeploying People and Equipment to Facilitate Full Approval of Vaccines
According to an article in the Washington Post, Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) the FDA is redeploying staff and added technical resources to accelerate the effort to grant full approval to the Pfizer vaccine. Later news items state that the FDA is aiming for early September to complete this task.

COVID-19 Infection

Vaccinated Patients Can Spread the Delta Variant
Based on an analysis of a large outbreak of COVID-19 associated with July 4 celebrations in Massachusetts, the CDC has determined that fully vaccinated patients can spread the virus as readily as unvaccinated patients. This formed the basis for the recent change in mask recommendations. The same analysis found that the vaccines provide significant protection, with only five out of 900 infected patients hospitalized in this state with high levels of vaccinated individuals.

Trends in Hospitalization in Children Younger Than 4 Years
COVID-NET, the CDC surveillance system, notes that compared to June 26, 2021, weekly rates for the week ending July 17 have tripled from 0.2 to 0.6 per 100,000 population. Rates of infection in older children have steadily increased since early July, and increased from 39,000 to over 72,000 in the last week of July. Allergists need to remember that children, who will be returning to school soon, may not be required to wear masks, are not eligible to be vaccinated if less than 12, and could be a risk to other children and immunocompromised adults. Be aware of your local school district requirements and be an advocate for your patients’ safety.

Treatment

CDC COCA Call on Options to Prevent Severe COVID-19 in Immunocompromised People
This Clinician Outreach and Communication Activity (COCA) call will occur on Thursday, August 12 from 2:00 to 3:00 pm ET. No need to register, but this is the Zoom link to join.

Expansion of Regeneron's EUA for Monoclonal Antibodies
Reuters has reported that the FDA expanded the EUA to allow use in individuals who have been exposed to an infected individual, or who are at high risk for exposure, particularly if those individuals are at high risk for severe infection.

Subcutaneous REGEN-COV Antibody Combination Effective at Preventing COVID-19
REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirimivab and imdevimab, previously had an EUA for IV administration for individuals at high risk for severe COVID-19. This study looked at using this combination subcutaneously in individuals with recent (within 96 hours) household contact and found a relative risk reduction of 81.4% of developing symptomatic SARS-CoV-2 infection in the next 28 days. Relative risk reduction was 66.4% for asymptomatic infection and those that did get infected had a two week shorter duration of symptoms.

FDA Grants EUA to New Biologic
The FDA has granted an EUA to GSK’s sotrovimab, a recombinant monoclonal antibody directed at a conserved epitope on the receptor binding domain of SARS-CoV-2, for the treatment of mild-to-moderate COVID-19.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 26, 2021

Here are today's important updates:

Vaccines

AAAAI Joins 50+ Health Care Professional Organizations in Support of Mandatory Vaccination Against COVID-19 for Health Care Workers
We’re proud to join 50+ major health care professional organizations & societies in calling for mandatory #COVID19 vaccination for all health care workers. Health care workers have a duty to protect their patients, and that means getting the #COVID19 vaccine. The vaccine is safe, effective, and our best tool for ending the pandemic. As the health care community leads the way in requiring vaccines for our employees, we hope all other employers across the country will follow our lead and implement effective policies to encourage vaccination. The health and safety of U.S. workers, families, communities, and the nation depends on it. Read the full statement.

Approaching the Vaccine Hesitant
Hopefully all of us are asking whether our patients have been vaccinated against SARS-CoV-2. These two resources (linked here and here) can help you understand what these individuals are thinking and perhaps how to approach them. Counseling can depend on age, race and political leanings. 

Get That Second Dose
Recent news reports note that millions of Americans are late for their second dose of vaccine. This article shows that efficacy against the delta variant is low after one dose, but markedly better after two. A mRNA vaccine was more effective against symptomatic disease compared to an adenovirus-vector vaccine but both are very effective against severe disease and death. 

Heterologous Vaccine Schedules
In this phase 2, open label randomized trial, 450 adults who had been vaccinated with the AstraZeneca vaccine 8-12 weeks prior were given a dose of Pfizer vaccine or continued observation. Compared to the control group, the boosted group showed an increase in receptor binding domain antibodies from 71.46 to 7756.68 BAU/ml and IgG against the trimeric spike protein increased from 98.40 to 3684.87 BAU/ml 14 days after dosing.

similar study published in the NEJM on July 14 indicated heterologous dosing resulted in a much larger booster response and improved efficacy against the beta variant. 

Very Rare Skin Reactions After Vaccination
In an article published online on July 15 in JACI, the authors report on a small number of cases (12) of subepidermal blistering eruptions following mRNA vaccination. It showed 3/5 of those who developed the reaction after the first dose of vaccine tolerated a second dose, but the second dose was withheld in the other two. 

In another paper published online in JACI: In Practice on July 19, authors from Spain report on 26 patients with a variety of other delayed skin reactions. Interestingly, almost half of these patients had evidence of prior COVID-19 infection. All but one of the patients tolerated a second dose of the vaccine, one refused the second dose. The paper lists the variety of skin manifestations that may occur. 

Guillain-barre Syndrome Increased After J&J Vaccine
The FDA, through the VAERS reporting system has identified 100 cases of Guillain-Barre (GBS) following 12.5 million doses of the J&J vaccine. This number represents a 3-5-fold increase over the baseline rate. These cases have not been fully investigated yet, and the Advisory Committee on Immunization Practices (ACIP) met on July 22 to discuss their recommendations, but the warning is listed on the updated vaccine information sheet. The slides from the ACIP meeting are available on their website. Analysis of the data from the Vaccine Safety Datalink system and the VA did not notice a statistical signal for GBS but cases were numerically greater after the J&J vaccine compared to the mRNA vaccines. The European Medicines Agency has also noted the same after the AstraZeneca vaccine and posted a similar warning on that vaccine. The conclusions of the CDC from this July 22 meeting is that benefits of the vaccine continue to outweigh the risks.

COVID-19 Infection/Transmission

SARS-CoV-2 Infection In the Immunodeficient Host
This article published online in JACI: In Practice on July 14 discusses the immune response to the virus, effects of infection in immunodeficient patients and potential therapies in immunodeficient patients, and may be of special interest to allergist/immunologists who care for patients with immunodeficiency. 

Long COVID
The CDC issued interim guidance on evaluating and caring for patients with Post-COVID conditions on June 14. A prospective study involving 410 symptomatic persons, mostly mild to moderate, who tested positive for COVID-19 seven to nine months previously and had been followed prospectively with virtual and telephone interviews found that 39% reported residual symptoms, with fatigue (20.7%) the most common symptom, followed by loss of taste or smell (16.8%), dyspnea (11.7%) and headache (10%).  

Practice

HHS Updates Provider Relief Fund FAQs
Health and Human Services added or modified questions/answers on July 1. Most of these relate to returning unused funds, reporting expenditures/loss of revenue, appeal process, time limits on utilization of funds and what to do if practices are bought or sold during this time. 

HHS Extends the Public Health Emergency
HHS announced a 90 day extension of the Public Health Emergency on July 20, extending it to October 20, 2021. All the CMS waivers and flexibilities will continue to be in effect.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 12, 2021

Here are today's important updates:

Vaccines

Vaccine Effectiveness Against the Delta Variant
Using samples from previously infected or vaccinated patients, this study found that while neutralizing activity was lower against the Delta variant, the majority of samples from infected patients and all samples from vaccinated patients still had detectable neutralizing activity above the threshold of detection. In a press release from the Israeli Ministry of Health, the Pfizer vaccine was only 64% effective in preventing infection, but 94% effective at preventing severe illness. In a pre-print, accepted manuscript, researchers from France examined the neutralization effectiveness in sera from patients vaccinated with either the Pfizer or AstraZeneca vaccines, and found that one dose of vaccine barely inhibited the variant, but two doses generated a neutralizing response in 95% of individuals, although less than that against the Alpha variant.

Addressing Vaccine Hesitancy
There are many reasons expressed by our patients for avoidance of the COVID-19 vaccines. Here are some studies that may speak to some of the hesitancies allergists may encounter:

Add “COVID Toes” to the Localized Skin Reactions to mRNA Vaccines
There have been a small number of cases of pernio/chilbain-like lesions on the toes of people vaccinated with the Moderna mRNA vaccine. Allergists should be aware of this in patients who are referred with lesions on the feet for possible allergy.

Pfizer to Seek Authorization for Third Dose
Pfizer and its partner BioNTech plan to seek FDA authorization for a third dose based on data to be submitted on an ongoing trial that shows an increase in the levels of neutralizing antibodies 5-10 times higher than baseline when administered 6 months after the second dose. They also plan to develop a vaccine that is targeted directly at the Delta variant. U.S. officials do not feel that a booster dose is indicated at this time.

COVID-19 Transmission/Infection

Pediatric Cases Now a Larger Share of Infections

In March of 2020, children made up 2% of new COVID-19 infections. By the end of May of 2021, the share increased to 24% of new weekly infections, even though children only make up 16% of the population. We need to remind parents of our pediatric patients to continue masking and avoiding crowded places.

HEPA Filtration Plus Masking for Exam Rooms
This study would suggest that adding a HEPA filter to an exam room would decrease aerosol exposure over masking alone.

Systemic Corticosteroid Use in Asthma Linked With Poor Outcomes, But Biologics Are Not
This study from Israel looked at all asthmatic patients in a large healthcare system who tested positive for SARS-CoV-2 between March and December, and compared risk of infection, severity or composite severity and all-cause morality. It found that biologics were not associated with any of these outcomes, but recent (within 120 days) use of systemic corticosteroids was significantly associated with increased risk of moderate to severe disease and composite of severity and mortality. Just an additional factor to use in attempting authorization for biologics in our severe asthma patients.

Practice

HHS Provider Relief Fund Reporting Portal Now Open
Providers who need to report in Reporting Period 1 have until Thursday, September 30 to submit their information as part of the post-payment reporting process. Hart Health Strategies, the AAAAI's legislative and regulatory consultants, has made several resources available for your assistance.

CMS Updates Its FAQs on Accelerated and Advance Payment
Review the updated COVID-19 Accelerated and Advance Payment (CAAP) Repayment & Recovery FAQs here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, June 28, 2021

Here are today's important updates:

Transmission

Spread of the Delta Variant of Concern (VOC)
The WHO announced recently that the Delta variant (B.1.617.2) first appearing in India, has now spread to 80 countries. In fact, 20% of recent U.S. cases are due to this virus and it has surpassed the Alpha variant (B.1.117) in the UK, where the Alpha variant originated. WHO is now tracking recent reports of a “Delta plus” variant. The Delta variant is more transmissible than the Alpha and may cause more severe disease. Current vaccines are effective against the Delta variant, although less so than against other variants. Keep encouraging your patients to get vaccinated to stop this parade of mutations and VOCs!
 
More on the Delta Variant
A study out of Scotland evaluated 19,543 confirmed cases of COVID-19 from April 1 to June 6, 2021. The adjusted hazard ratio for hospitalization with the Delta variant was 1.85 (95% CI 1.39-2.47) compared to the Alpha variant. 70% of Delta cases had not been vaccinated. Vaccine effect did not clearly manifest until at least 28 days after first vaccine dose. There was no difference in vaccine effect against Alpha or Delta variants with respect to hospitalizations, with a reduction in hospitalization hazard ratio of 0.28 for the Alpha variant and 0.38 for the Delta variant.
 
So Who Is Following the Guidelines?
This AP NORC poll conducted from June 10-14 indicates that vaccinated people are much more likely to be avoiding large groups, wearing a face mask and avoiding nonessential travel compared to unvaccinated people even as restrictions are loosened for the vaccinated.
 
Cold Viruses Are Coming Back Out of Season
This report from the Washington Post notes a resurgence of common respiratory viruses now occurring out of their typical season as the country re-emerges from COVID-19, with schools opening and reduced mask use. Note the CDC warning about RSV that was in our last message.

Vaccines
 
ACIP/CDC Update on Myocarditis/Pericarditis
The ACIP discussed this issue at their scheduled meeting on June 23. There have been 484 cases reported to VAERS, 323 of which have been confirmed. Rates are highest in males, with the highest incidence in those aged 18-24 where the rate is 219 per million doses, so very rare. Although most have been hospitalized, the overwhelming majority of cases have been mild, treated with NSAIDs or steroids with discharge within 2-4 days. The CDC, along with a number of other national medical societies including the AAP, ACOG, AAFP, ACP, and AHA have recommended the benefits of vaccination far outweigh the risks of vaccine complications and vaccines are strongly encouraged. The ACIP does plan to add a statement on myocarditis in the vaccine facts document. Check here for the slides from the meeting.
 
Booster Doses
At the same meeting mentioned above, the booster work group from the CDC stated: “No data to support recommendations for booster doses currently, but will continue to monitor.” There are several studies ongoing in special populations and with vaccine effectiveness with variants that are anticipated this fall.
 
CDC Updates Considerations for Vaccines
Last updated on June 1, information of interest to the allergist includes clarification on contraindications and precautions and an updated Appendix B on guidance for people with a history of an immediate allergic reaction to a vaccine or injectable therapy that contains a component also contained in a COVID-19 vaccine. It’s important to remember: “Allergic reactions (including severe allergic reactions) not related to vaccines (COVID-19 or other vaccines) or injectable therapies, such as allergic reactions related to food, pet, venom, or environmental allergies, or allergies to oral medications (including the oral equivalents of injectable medications), are not a contraindication or precaution to COVID-19 vaccination.”
 
Self-Reported Allergic Reactions and Subsequent Vaccine Dose
Self-reported allergic symptoms following the first dose of mRNA vaccine was associated with a 5-fold (3% vs. 0.6%) increase in odds of not completing the second dose in a prospective cohort of healthcare workers in Boston. We know that most of these people can get the second dose, so allergists need to be consulted in anyone who might be reluctant to get the second dose.
 
Cutaneous Reactions After mRNA Vaccines
This study from the Mass General Brigham group involved 40,197 employees who completed symptom questionnaires after their first dose. Cutaneous reactions were reported by 776 (1.9%), with rash and itching (other than at the injection site) most common. Reactions were much more common in women (85% vs. 15%). Of these patients, 741 (95%) went on to receive a second dose, and 508 out of 609 who completed the symptom survey (85%) reported no recurrent cutaneous reactions.
 
Role for Excipient Skin Testing After First Dose Reactions to mRNA Vaccines
In this small study of 80 individuals who reported allergic reactions after the first dose of mRNA vaccines, excipient skin testing to PEG and/or polysorbate 80 did not impact tolerance of the second dose in those with positive skin tests. 70 out of the 80 received their second dose, 62 had either no reaction or a mild reaction managed by antihistamines, although two did require epinephrine.
 
Immunity From Infection Versus Vaccine - Is It Different?
A recent NIH-funded study adds to the evidence base that patients with acquired immunity may have different levels of protection by showing that antibodies generated following vaccination are more focused on the receptor binding domain (RBD) of the spike protein compared to the antibodies generated after acquired infection. Findings from this study suggest the vaccine-generated immunity may be more likely to target new SARS-CoV-2 variants potently even when the variants contain new mutations in the RBD.
 
Immunity After Infection Long-Lasting But Enhanced by Vaccination
This paper reports that 82% of 68 individuals recovered from COVID-19 showed continued IgG antibody titers and B cell memory 6-12 months after infection. In the participants who were vaccinated after infection (41%) IgG responses increased 30-fold, neutralizing activity by 50-fold and circulating number of memory B-cells by 9-fold.

Practice
 
HHS Modifies PRF FAQs
New or modified questions relate to set periods of time in which providers must use funds (e.g., funds received between April 10 and June 30, 2020, must be used by June 30, 2021, and so on),if providers can use payments for expenses prior to receipt of PRF funds, what to do with remaining PRF money, and auditing and reporting requirements.
 
AMA Announces That 96% of Practicing Physicians Have Been Fully Vaccinated
It's important to note that this data comes from a survey done from June 3-8 with a response from 300 physicians, half of whom were primary care

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, June 14, 2021

Here are today's important updates:

Vaccines
 
Allergic Reactions After COVID-19 Vaccine and Incomplete Vaccination
This prospective study of Mass General Brigham employees (50,167) was done following their first dose of mRNA vaccine. A total of 1,261 (2.5%) self-reported allergic symptoms, and 576 (46%) received an A/I consultation. While the adjusted odds ratio for incomplete vaccination was 5.15, 95% CI 3.75,7.06 for any self-reported allergic reaction and 23.19, 95% CI 9.74, 55.22 for severe allergic reactions, 1,218 of the 1,261 received the second dose and 17% had recurrent allergic symptoms. None were severe.
 
Update on Myocarditis/Pericarditis After mRNA Vaccines
Increased cases have been noted since April predominately in male adolescents and young adults 16 years of age and older, with onset within several days of vaccination, more after the second dose. Most cases have been mild and responded well to medications and rest. Allergists take note: patients present with acute chest pain and shortness of breath and may occur in your asthma patients. Consider an ECG, troponin level, EST, C-reactive protein, and consider acute or previous COVID-19 as etiology as well.
 
Efficacy of Single Dose of Pfizer Vaccine
This study from Israel involving 351,897 individuals found that the overall single-dose vaccine effectiveness of the Pfizer vaccine against symptomatic COVID-19 was 54.4% when measured 13-24 days after the dose. Results were similar across ages, genders and in individuals with comorbidities. Protection against severe disease is presumed to be higher, but this was not measured in the study.
 
Immunogenicity of J&J Vaccine (Ad26.COV2.S) Against Variants May Be  Better Than We Thought
While neutralizing antibody titers may be three to five fold less against the variants B.1.1.7, CAL.20C, P.1 and B.1.351 compared to the Wuhan strain (WA1/2020), this small study showed that non-neutralizing antibody responses and T cell responses were largely preserved against these variants.
 
Moderna to Apply for EUA for 12-17 Year Olds
The New York Times reported that Moderna filed for the EUA on 6/10. Their study in 3,732 children showed a vaccine efficacy of 100%. FDA approval of the EUA is expected in early July.
 
Vaccine Misinformation
The CDC has a resource page that may be useful to allergists who are talking to their patients about getting a vaccine against COVID-19. Refer your patients to this page: Myths and Facts about COVID-19 Vaccines. Facebook is becoming one of the leading sources of misinformation on COVID-19 vaccines.
 
Most Unvaccinated Adults Plan to Stay That Way
Allergists need to ask each and every patient if they are vaccinated and if not, why not. A recent Gallup poll found that 78% of U.S. adults who have not yet received a vaccine say they are unlikely to ever get it. On the positive side, 76% of adults have received at least one dose or “plan to get one.”
 
Treatment
 
Early Monoclonal Antibody Treatment
Treatment with casirivimab/imdevimab (83% of patients) and bamlanivimab (17% of patients) within five days of diagnosis in high risk patients was noted to decrease hospitalization and mortality. This was a retrospective study on 617 patients of a COVID-19 clinic at University of California, San Diego.
 
FDA Approves Injection Form of Monoclonal Antibodies
The FDA just approved REGEN-COV by means of injection, rather than IV infusion and also approved a lower dose.
 
Transmission

Are Americans Still Social Distancing?
Another recent Gallup poll found that less than 25% of Americans continue to practice safe social distancing, though 44% are avoiding crowded places.
 
SARS-CoV-2
 
Variants of Interest
Information has changed on distribution and nomenclature of the variants of interest (VOI) and variants of concern (VOC). WHO just agreed to use a new, simpler naming system. B.1.1.7 (UK variant) now called Alpha variant, B.1.351 (South African variant) now Beta, P.1 (Brazil) now Gamma, and B.1617.2 (India) now Delta. Consult the CDC website which was updated June 8 or visit the AAAAI COVID-19 resources page and check under Virus Variants.
 
Increased RSV Activity in Parts of the Southern U.S.
The CDC has issued a health advisory about increased interseasonal RSV in the southern U.S. and recommends testing for that infection in patients with acute respiratory illness who test negative for SARS-CoV-2.
 
ICS Therapy for COPD Safe
A large retrospective study involving 27,810 patients showed that ICS treatment for COPD did not increase the risk for hospitalization, ICU admission, mechanical ventilation or mortality from COVID-19.
 
CDC Adds Health Equity Data Page to Their COVID Data Tracker
Find it at: Health Equity Data. Other pages concerning the CDC and health equity related to COVID-19 can be found here: Health Equity, Promoting Fair Access to Health and Health Equity in Action.
 
Practice
 
HHS Revises Reporting Requirements and Timeline for PRF Recipients
This announcement includes expanding the amount of time providers will have to report information, aims to reduce burdens on smaller providers, and extends key deadlines for expending PRF payments for recipients who received payments after June 30, 2020. The revised reporting requirements will be applicable to providers who received one or more payments exceeding, in the aggregate, $10,000 during a single Payment Received Period from the PRF General Distributions and/or Targeted Distributions.
 
OSHA Announces a COVID-19 Safety Rule
It seems a little late in the game, but OSHA issued an emergency temporary standard (ETS) on 6/10 which applies to healthcare workers in healthcare settings where suspected or confirmed COVID-19 patients are treated. This may not apply to most allergist offices, but you need to be aware of the standard. Interestingly, the ETS exempts fully vaccinated workers from masking, distancing, and barrier requirements when in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present. The ETS becomes effective on the day it is published in the Federal Register, and healthcare facilities have 14 days to comply. Most practices are already doing these things, but you need to check and be sure. Practices with more than 10 employees that don’t meet the exceptions will need a written COVID-19 plan.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, June 1, 2021

Here are today's important updates:

Our COVID-19 messages will be transitioning to every two weeks after this issue. Be sure to check the AAAAI COVID-19 resources page for continuous updates.

Vaccines

Talking to Your Patients About Getting Their COVID-19 Vaccine

The CDC has produced a comprehensive resource for providers on counseling patients about getting a vaccine, including communication points and ideas about proactive patient outreach. This is also linked on the AAAAI COVID-19 resources page.
 
Anaphylaxis to mRNA Vaccines

In our last message, we posted about a patient with anaphylaxis to the mRNA vaccine who was allergic to PEG. In a letter to the editor soon to be published in Allergy, researchers from Vanderbilt and Denmark report on eight healthcare workers referred for evaluation after a first dose anaphylactic reaction based on the Brighton Collaborative, NIAID/FAAN or Ring and Messmer validated scales. Serum tryptase levels were normal in the five who had that done, allergy to PEG (by skin testing to PEG 3350 and/or challenge and negative tolerance history) was ruled out (in the opinion of the authors), and the eight patients went on to tolerate the second dose of the vaccine as a single dose with antihistamine pre-treatment with lesser or no symptoms. The authors propose that this may indicate a non-IgE-mediated reaction and posit that pre-treatment with antihistamines can reduce some of the symptoms due to mast cell mediator release in the absence of an IgE-mediated reaction.
 
Breakthrough Infections After Vaccination

The CDC is working with state and territorial health departments to investigate SARS-CoV-2 infections among persons who are fully vaccinated. A total of 10,262 breakthrough infections had been reported as of April 30. Based on preliminary data, 27% were asymptomatic, 10% were known to be hospitalized (29% of these were asymptomatic or hospitalized for a reason unrelated to COVID-19), and 2% died (18% asymptomatic or died from another cause). The median breakthrough infection age was 58 (interquartile range 40-74), and the median age of those who died was 82 (interquartile range 71-89). Sequence data was only available from 5% of the cases, 64% of which were identified as variants of concern, with 56% of those B.1.1.7 and 25% B.1.429. Following release of this study, the CDC announced that they would be investigating only those breakthrough infections that result in hospitalization or death.

A study from Italy on reinfections 10-15 months after initial infection revealed a incidence density of 1.0 per 100,000 person days for reinfections compared to 15.1 for new infections, indicating prolonged protection against reinfection from natural infection.
 
Moderna to Submit an EUA for Ages 12-17 in June

Studies have shown similar immune response and vaccine efficacy as in older patients, as well as a similar safety profile.
 
Novavax Plans to Apply for an EUA for Their Vaccine in July

According to another article in the Washington Post, this nanoparticle vaccine has been shown to be 90% effective in UK trials. It is being studied in a 30,000 person trial in North America and the company expects to have the data from that trial complete by the end of the month.
 
Inactivated Virus Vaccines Show Efficacy

Two inactivated SARS-CoV-2 vaccines, using different strains of the virus, were 72-78% effective in preventing symptomatic infection in an interim analysis of data from a trial in 38,206 subjects. The vaccines were 100% effective against severe disease.
 
Myocarditis and Pericarditis After mRNA Vaccines

The CDC has added resources for the public to their website.

Transmission

Prevalence of Pediatric Infection in UK

A surveillance study of pediatric patients admitted to a hospital for any reason in the UK from March 2020 to February 2021 noted that 5.6% tested positive for SARS-CoV-2, 20% of whom were asymptomatic. The prevalence of new asymptomatic infections increased 1.65-fold during times when schools were open.
 
COVID-19 in Daycares

In this study among 469 child care facilities in Washington, DC, 23.9% reported at least one COVID-19 case, and 5.8% reported outbreak-associated cases during July 1-December 31, 2020. Outbreak-associated cases accounted for almost half of reported cases. Among 319 cases, approximately one-half were among teachers or staff members. Outbreak risk was increased in facilities operating <3 years, with symptomatic persons who sought testing 3 days or more after symptom onset, or with asymptomatic cases.

Immunity
 
Immunity to SARS-CoV-2 Infection May Last A Year

This study in 77 patients with a history of mild infection demonstrated long-lived SARS-CoV-2 specific bone marrow plasma cells, which correlated with serum anti-SARS-CoV-2 spike antibodies detectable at least 11 months after infection.

Infection
 
Persistent Symptoms After Infection

In this systematic review of 45 studies including 9,751 participants with COVID-19, the median proportion of individuals who experienced at least one persistent symptom was 73%. Symptoms occurring most frequently included shortness of breath or dyspnea, fatigue or exhaustion, and sleep disorders or insomnia.
 
Treatment
 
Study Suggests That Home Monitoring of Oxygen Saturation and Respiratory Rate Are Important

This study examined mortality in hospitalized patients with COVID-19 and noted that while many had hypoxemia and tachypnea on admission, few reported shortness of breath or cough. Patients with hypoxemia (O2 sat <92%) had a 1.8 to 4.0-fold increased mortality risk. The authors suggest that patients with other risk factors monitor respiratory rate and oxygen saturation at home and seek medical care if O2 sat is <92% and/or respiratory rate is >23 breaths/minute, when early treatment might be most helpful.
 
New Monoclonal Antibody

The FDA has granted an EUA for sotrovimab to GSK for the treatment of mild-to-moderate COVID-19 in patients at risk for progression. Sotrovimab is a recombinant human IgG1 kappa monoclonal antibody that binds to a conserved epitope on the spike protein receptor binding domain. Laboratory testing showed that sotrovimab retains activity against the current circulating variants first reported in the UK, South Africa, Brazil, California, New York and India.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, May 24, 2021

Here are today's important updates:

Vaccines

Anaphylaxis After Vaccination Linked to PEG Allergy in One Patient

Researchers in the UK have linked anaphylaxis after the Pfizer vaccine in one patient to her allergy to PEG. She had a history of anaphylaxis to azithromycin, which contained PEG with less severe reactions to shampoo, toothpaste and mouthwash also containing PEG. She had a systemic reaction while undergoing skin testing to a 1% concentration of PEG 4000.

Update on TTS After J&J Vaccine

Updates on TTS were given at the ACIP meeting on May 12. Cases now number 28 out of 8.7 million doses of J&J vaccine given. The median age is 40 (up from previous data). Median time to onset is nine days (range 3-15). It was reported in 22 females and six males, and 19 of the 28 had CVST (cerebral venous sinus thrombosis).

Myocarditis/Pericarditis After Vaccination

The Seattle/King County Public Health Department recently sent out a health advisory concerning 12 reported cases of myocarditis or pericarditis within two weeks following a mRNA vaccine. Ages range from 16-66 years, mostly males. Symptoms include chest pain or pressure, shortness of breath, EKG abnormalities, and abnormal cardiac enzymes. The ACIP COVID-19 Vaccine Safety Technical (VaST) Work Group session on May 17 heard several presentations on this from the Department of Defense, VAERS, and Vaccine Safety Data Link (VSD). VaST concluded that there are relatively few reports of this, they were predominately occurring in adolescent and young adult males following mRNA vaccine, more often after dose two, occurring four days to two weeks after vaccination and most were mild. Within the CDC monitoring systems, rates of myocarditis have not differed from expected baseline rates, but these reports should be communicated to providers. This is important to allergists because the presentation of chest pain/pressure and shortness of breath would not be unusual in a practice. If myocarditis is confirmed, be sure to report this to VAERS.

Mixing Vaccines – Reactogenicity Data

This UK multi-center randomized heterologous prime-boost COVID-19 vaccination study compared the AstraZeneca and Pfizer vaccines in various prime-boost permutations in 830 patients 50 years of age and older. Results showed that systemic reactogenicity was greater following the boost dose in heterologous schedules compared with homologous dosing. Symptoms were similar to those well known after receipt of the vaccines, but about twice as common when the prime dose and the boost dose were from different vaccines. The efficacy data is expected in June.

Why Are Vaccine Hesitant Americans “Hesitant”?

Results of a recent Harris poll taken from over 1,000 Americans who identify as unlikely to get a vaccine show that 60% cite blood clots, 57% cite systemic reactions to the vaccine, 45% cite death, 37% cited migraines and about 1/4 cited high blood pressure, DNA alterations, birth defects, infertility and cancer as reasons to not be vaccinated. It helps allergists to be familiar with the common reasons for avoidance so we can properly advise our patients.

CDC Updates Guidance on Coverage & Reimbursement of Vaccines for State Policymakers

On May 5, the CDC released an update of their vaccine toolkit for policymakers at the state level, concerning vaccine coverage, administration and cost-sharing under Medicaid, CHIP and Basic Health programs.

Immunity

Antibody Response Targets Many Parts of The Spike Protein

Recent research sponsored by the NIH and recently published in Science evaluated the array of antibodies against SARS-CoV-2 in a small number of patients who had recovered from natural infection. Most studies to date have focused on the antibody response to the receptor-binding domain (RBD), but these researchers found that about 84% of the antibody response targeted other portions of the spike protein. Among these are antibodies that target the N-terminal Domain (NTD) and these antibodies can neutralize the virus. The NTD is one part of the spike protein that has mutated frequently, especially in the variants of concern, allowing these viral variants to escape the effects of these antibodies. Fortunately, about 40% of the antibody response is directed toward the S2 subunit which is not as mutable as the NTD. The study can be found here. A nice summary with a helpful cartoon of the spike protein can be found in the NIH directors blog: Human Antibodies Target Many Parts of Coronavirus Spike Protein.

Transmission

Possible Explanation For Prolonged Shedding of SARS-CoV-2

Patients with COVID-19 are known to have continued positive RT/PCRs for SARS-CoV-2 for 30 days or more after infection. Data available indicate that these patients are not infectious, but why do some continue to have positive RT/PCR? This study found that SARS-CoV-2 RNA can be reverse-transcribed and integrated into the genome of the infected cell and be expressed as chimeric transcripts fusing viral with cellular sequences. Such chimerics are detected in patient-derived tissues and may explain the prolonged presence of viral RNA. This could also be pointed out to vaccine hesitant patients who are concerned about genetic effects of the vaccine.

COVID-19 Infection

Risk of Reinfection

A study of 16,101 college students in South Carolina found that the risk of reinfection was 2.2% while estimated protection from previous infection was 84%. The median time to reinfection was 129 days.

Levels of Co-infection And Super-infection Found in Infected Patients

A meta-analysis of 118 studies found that up to 19% of patients had co-infection (other pathogens identified at the time of COVID-19 diagnosis) and 24% had super-infection (other pathogens detected during COVID-19 care). Such patients had an increased risk of mortality (OR 3.3). Co-infecting pathogens most common were influenza A and B and RSV.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, May 17, 2021

Here are today's important updates:
 
Vaccines
 
CDC Revises Guidance for Fully Vaccinated

Updated on May 13, the new guidelines state that fully vaccinated people can resume activities without wearing a mask or physically distancing, except where required by federal, state or local laws, rules and regulations. These recommendations are NOT intended for healthcare settings. You will still need to be tested when returning from international travel, and you will still need to wear a mask on planes, buses, trains and other forms of public transportation.
 
More Data on Real World Effectiveness of mRNA Vaccines

Interim data analysis from a test-negative design case-control study involving healthcare professionals ongoing at 33 sites across the United States showed vaccine efficacy of 82% after one dose and 94% after two.
 
FDA Authorizes Pfizer Vaccine for Emergency Use in Adolescents, CDC's ACIP Adds Interim Recommendation

Announced on May 10, the ACIP met on May 12 to decide how it is to be used. The ACIP analysis of the data from the clinical trial involving 2,200 adolescents noted efficacy of 100% against symptomatic infection. Immune responses were at least as high as those found in ages 16-25. There were 16 cases of COVID-19 in the trial, all in the placebo group. As noted in an earlier message, Pfizer also plans to seek full authorization by the end of May, which would allow their vaccine to be used after the pandemic emergency is over. Currently, EUAs expire at the end of the public health emergency. Full authorization should help convince some people who have been concerned about the speed of development and “emergency authorization” to go ahead with vaccination and would allow schools, etc. to mandate immunization.
 
Survey on Parental Attitudes Toward Vaccination of Children

This report from the COVID States Project: A 50-State COVID-19 Survey found that 11% of fathers are resistant to vaccination compared to 27% of mothers. Educational, income and partisan divides have become more pronounced, with college-educated, higher income and Democratic parents showing less resistance compared to those of low income, non-college educated or Republican parents who have increased their resistance. Parents of teenagers are less resistant and 58% support school vaccination requirements.
 
Moderna Vaccine Updates

In a press release from May 6, Moderna announced that in an updated review of the initial trial data, vaccine efficacy remained at 90% against all cases and 95% against severe disease 6 months after the second dose. Initial data from their Phase 2 study on booster doses against variants of concern showed that both the 50 mcg booster directed at the B.1.351 variant (mRNA-1273.351) and the 50 mcg booster of the original vaccine (mRNA-1273) increased neutralizing titer responses against B.1.351 and P.1, with the strain-matched booster showing better effect. Safety and tolerability was similar to the second dose of mRNA-1273. The Phase 2/3 study of mRNA-1273 in adolescents aged 12-17 has completed enrollment and initial results indicate 96% efficacy. Tolerability was comparable to that in adults.
 
Pfizer Vaccine Effects Against New Variants

In a small study on viral neutralization in vaccinated patients, these authors found that neutralization following vaccination was essentially equivalent against the new strains, including the new California and New York strains, as well as the recently identified B.1.1.7 variant.

COVID-19 Infection
 
Updated Guide to SARS-CoV-2 Variants

If you are having trouble keeping track of all the variants and the mutations that are present, this CDC resource will help spell it all out for you. The link is also listed on the Virus Variants and Vaccine Information section of the AAAAI COVID-19 resources page.
 
Viral Attack Rates

Among 2.5 million contacts of 1 million index cases of COVID-19 in the UK, researchers found that the B.1.1.7 variant had 55% attack rates. Attack rates were highest for household contacts (9%), followed by household visitors (7%), and lower among work/education contacts (5%) and outdoor contacts (3%). Contacts of children were least likely to test positive, particularly following contact outdoors or at work/educational settings.
 
Airborne Transmission

The CDC added back the notion that SARS-CoV-2 can spread via airborne transmission on May 7, which they admitted in earlier guidance but removed. Although this has been a source of controversy, there is a moderate degree of scientific evidence to support the notion that infectious material can spread beyond six feet in the form of aerosol particles. This article outlines methods and targets for improvement of indoor ventilation and filtration to reduce the risk of infection.
 
Duration of Immunity Updates

In this small study (32 patients) from Canada, 13 patients who were 8 months post-infection continued to show stable numbers of IgG-positive B cells and ADCC.

Another study from China assessed humoral, T and B cell responses in 59 asymptomatic to moderate COVID-19 patients a median of 317 days from symptom onset (range 257-343 days), and found that 90% still had detectable IgG antibodies against spike and nucleocapsid proteins and neutralizing antibodies against pseudovirus. Sixty percent of patients had detectable IgG antibodies against the receptor binding domain and surrogate virus-neutralizing antibodies, and SARS-CoV-2 specific IgG memory B cells and IFN-gamma secreting T cells were detectable in over 70% of patients. Interestingly, the immune response was greater in those who had asymptomatic/mild infection compared to those with moderate disease.

Future Research
 
NIAID Announces Updated COVID-19 Research Plan

The 2021 research plan update focuses on four priorities: 1) advance basic research, 2) identify and test promising COVID-19 therapeutics, 3) develop and test next-generation COVID-19 and pan-coronavirus vaccines, and 4) characterize, prevent and treat post-acute sequela of SARS-CoV-2 infection (PASC).

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, May 10, 2021

Here are today's important updates:

Vaccines
 
ACIP Meeting on Pfizer EUA Application for Ages 12-15

This virtual meeting will take place May 12 from 11:00 am to 3:30 pm ET. Following the Pfizer discussion and vote, there will be a session that will provide updates on TTS after the Janssen vaccine, COVID-19 vaccine effectiveness and virus variants. The agenda and webcast link can be found here.
 
Skin Reactions to mRNA Vaccines

Utilizing data from the international COVID-19 Dermatology Registry, this presentation at the American Academy of Dermatology (AAD) Virtual Meeting last month detailed reactions from 414 unique individuals who developed cutaneous reactions following the Moderna (83% of cases) or Pfizer vaccine (17%). The most common reactions were delayed large local reactions, urticaria and morbilliform eruptions. Delayed large local reactions occurred around day 7. The urticaria started around day 3 and occurred on the arms, trunk or legs, and the morbilliform rash also started around day 3 with similar distribution to the urticaria. These reactions occurred mainly in females and only 43% recurred after the second dose.
 
Symptomatic and Asymptomatic Infection After Pfizer Vaccine

A retrospective cohort study from Israel looked at COVID-19 infections in 5,517 fully vaccinated healthcare workers. The adjusted incidence rate ratio (IRR) (incidence rate in vaccinated/incidence in unvaccinated) was 0.03 (95% CI, 0.01-0.06) for symptomatic infection and 0.14 (95% CI, 0.07-0.13) for asymptomatic infection.
 
In a U.S. study performed on 2,776 healthcare workers, the IRR for asymptomatic infection 7 or more days after a second dose was 0.10 (95% CI, 0.04-0.22). There were no symptomatic infections in this group 7 or more days after the second dose.
 
Pfizer Vaccine and Variants

In a letter to the editor, researchers in Qatar using data from their COVID-19 national database noted vaccine efficacy against any documented infection with the B.1.1.7 variant was 89.5% and vaccine efficacy against any documented infection with the B.1.351 variant was 75%. Efficacy against severe, critical or fatal disease at a time when 50% of the cases were due to the B.1.351 variants and 45% due to B.1.1.7 variants was 97.4%. These numbers were confirmed using a cohort study design as well.
 
Vaccine Penetration and Infection Scenarios - Hope Lies Ahead!

Modeling of future cases, hospitalizations and deaths by vaccination rates and nonpharmaceutical intervention (NPI) was done across four scenarios of vaccination rates and NPI adherence. The most optimistic scenario indicates that with high vaccination coverage and moderate NPI adherence, hospitalizations and deaths will likely remain low nationally, with a sharp decline in cases projected by July 2021. On the other hand, a sharp decline in NPI adherence was shown to undermine vaccination-related gains, especially with low vaccination rates. There is likely to be state-wide variation in the scenarios due to differences in NPI adherence and vaccination rates.

Another modeling study demonstrated that every 1% increase in vaccination coverage could avert an average of 876,800 cases depending on the number of persons already vaccinated, with the greatest gains achieved when increasing vaccination coverage in the population from 0% to 50%. The study also demonstrated that increasing vaccination coverage may avert more cases than increases to the vaccine efficacy.
 
Novavax Vaccine Effectiveness Against B.1.351

In this study, the Novavax nanoparticle vaccine showed 51% efficacy against the virus variant B.1.351.
 
Extended Shelf Life Possible for Moderna Vaccine

In a press release on April 29, Moderna announced that ongoing development data related to the current formulation of the Moderna COVID-19 vaccine (mRNA-1273) could support a 3-month refrigerated (2-8°C) shelf life for the vaccine in alternative formats to facilitate easier distribution to doctor’s offices and other smaller settings if authorized. This change is not yet FDA approved. Currently, the Moderna COVID-19 vaccine is approved for storage up to 1 month at refrigerated temperatures (2-8°C) and up to 7 months in a standard freezer (-20°C).

COVID-19 Infection
 
Update on Children

The cumulative number of child cases (3,782,274) represents 13.8% of all cases, but for the week of April 22-29, 2021, children represented 22.4% of the new weekly cases. Also, 0.1-1.9% of all cases resulted in hospitalization, with up to 0.03% of cases resulting in death.
 
Impact on Children

COVID-19 certainly has a direct disease impact on children, but can also affect them in other ways without infection. This modeling study suggests that as of February 2021, 37,300 children ages 0 to 17 years had lost at least one parent due to COVID-19. If you include excess deaths, that number increases to 43,000.
 
Lawmakers Pressing Major Insurers Who Announced Resumption of Cost-Sharing for COVID-19 Treatments

AMA Morning Rounds reported that 10 Democratic members of Congress have sent letters to the CEOs of Anthem, UnitedHealthcare and Aetna urging the insurers to waive cost-sharing for COVID-19 treatment.

Practice
 
CMS Increases Payment for Monoclonal Antibody Infusions

Effective May 6, the national payment rate for administration of monoclonal antibodies for COVID-19 will increase from $310 to $450 for most healthcare settings, with a rate of $750 when administered in the beneficiary’s home. Beneficiaries pay nothing out of pocket.
 
COVID-19 Coverage Assistance Fund (CAF)

A webinar May 12 at 2:00 pm ET will present an overview of the enrollment, claims submission and payment processes. Register here. See also the fact sheet on the program.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Thursday, May 6, 2021

Here are today's important updates:

Vaccines
 
New Resource for Vaccine Availability

The CDC and HHS have announced a service, available now, allowing people to find COVID-19 vaccines nearby via text message. Anyone can text their ZIP code to GETVAX in English, or VACUNA in Spanish, to get information on three locations near them with available vaccines. Also announced was the conversion of VaccineFinder.org to a new site, Vaccines.gov, which will report information for all states. The website is currently available in English and Spanish. The National COVID-19 Vaccination Assistance Hotline, a 1-800 number to be announced, will be available for people who prefer to use the phone. Assistance will be provided in English, Spanish and more than 150 other languages and will also include a teletype line for the hearing impaired.
 
Canada Announces Emergency Authorization for Pfizer Vaccine in Ages 12-15
 
The FDA is expected to consider an EUA for the same age range in meetings this next week, according to an article in the New York Times. In another article from the New York Times, Pfizer will seek full authorization for its vaccine for ages 16-85 in the next month and will hope to apply for an EUA for ages 2-11 by September.
 
B and T Cell Responses After One Dose of Pfizer Vaccine in Those With Prior Infection

A study in a cohort of UK healthcare workers who had been followed serially since March of 2020 noted that after one dose, individuals with prior infection showed enhanced T cell immunity, antibody secreting memory B cell response to spike and neutralizing antibodies effective against B.1.1.7 and B.1.351. Those without prior infection showed reduced immunity against the variants. Remember that this is after one dose.
 
CDC Reports Clusters of Anxiety-Related Events After Janssen Vaccination

The CDC received reports of clusters of anxiety-related events over a 3-day period of time (April 7-9) after administration of the Janssen vaccine at five mass-vaccination sites, all in different states. Overall there were 64 events, including 17 with syncope among 8,624 recipients. As follow-up, the CDC analyzed reports of syncope shortly after Janssen vaccine to VAERS for the period March 2-April 22, and compared them to reports of syncope after administration of the influenza vaccine during the 2019-2020 season. The rate of syncope after the Janssen vaccine was calculated at 8.2 per 100,000 doses compared to 0.05 per 100,000 doses after influenza vaccine.
 
CVST and the Janssen (J&J) Vaccine

In addition to the CDC COCA call mentioned in our last message, JAMA has published an article and editorial on this serious adverse event.
 
HHS Launches New Reimbursement Program for COVID-19 Vaccine Administrative Fees Not Covered by Insurance
 
Called the COVID-19 Coverage Assistance Fund (CAF) funded through the Provider Relief Fund, this program will cover the costs of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. Since providers cannot bill patients for COVID-19 vaccine fees, this will fulfill a compensation need for providers. The CDC issued guidance in February that all organizations and providers participating in the CDC COVID-19 Vaccination Program (which currently includes any provider administering the vaccine): 1) must administer the vaccine regardless of the recipients ability to pay administration fees or coverage status, 2) must administer COVID-19 vaccine at no out-of-pocket cost to the recipient, and 3) may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the recipient.
 
Reminder: NIH Study on Vaccine in Highly Allergic/Mast Cell Disorder Patients to Complete Enrollment in June

The NIH is currently enrolling highly allergic or mast cell disorder patients in a multicenter study to determine risks for allergic reactions to the mRNA vaccines. Twenty-nine sites around the United States are currently enrolling patients with a history of severe allergic reactions to foods, immunotherapy or insects with use of epinephrine in the last 5 years, history of documented allergic reactions to two or more unrelated drugs within the last 5 years, convincing history (with/without positive skin test) of an immediate reaction to a drug or vaccine within the last 5 years, or physician-diagnosed mast cell disorder. Details can be found at Clinical Trials.gov. The AAAAI podcast series also has a new episode discussing the study.

COVID-19 Infection
 
Cytokine Profiles May Be Predictive of Mortality
 
This study looked at the level of certain cytokines on hospital admission and compared the results in patients who did not require invasive ventilation, those who did require invasive ventilation and those who required ECMO, and found that high levels of TNF-alpha, IL-6, IL-8 and IL-10 were characteristic of ECMO patients, whereas high interferon levels characterized non-ventilated patients.
 
COVID-19 Infection in Patients With Inborn Errors of Immunity

In this paper from Italy, patients with inborn errors of immunity (IEI) were no more likely to be infected or die from COVID-19 infection, although death occurred at a younger age and was not associated with the co-morbidities seen in those without IEI.

Therapeutics
 
IVIG

Several small studies (cohort, randomized double blind or retrospective) have shown benefit from early use of IVIG. This study, a randomized, parallel group controlled trial in 100 patients with moderate pneumonia due to COVID-19 in India, studied IVIG 0.4g/kg daily for 5 days at hospital admission. The primary outcome, days of hospitalization, was 7.72 in the treated group and 17.50 in the control group (p <.0001). Significant effects were also noted for clinical severity and days on mechanical ventilation. The NIH treatment guidelines currently state that IVIG should not be used outside of a clinical trial, but they have not been updated since July of 2020.
 
NIH To Start Clinical Trials for Mild-to-Moderate and Severe COVID-19

The ACTIV-6 trial will explore a pool of up to seven drugs that can be self administered that have already been FDA approved for other purposes.

The ACTIV-3 trial will test Zyesami, a formulation of aviptadil acetate, a synthetic version of vasoactive intestinal peptide (VIP), with or without remdesivir in severely ill patients with acute respiratory failure.

The ACTIV-2 trial, a Phase 2/3 trial to evaluate a new fully-human polyclonal antibody targeted to SARS-CoV-2, called SAB-185, has begun enrollment in non-hospitalized patients with mild or moderate cases of COVID-19. Other therapeutics being studies in ACTIV-2 include two other experimental antibodies, inhalable beta interferon (SNG001), a long-acting monoclonal antibody (AZD7442), and Camostat medilate, an orally administered serine protease inhibitor.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, May 3, 2021

Here are today's important updates:

Vaccines
 
Systemic Side Effects Uncommon in Real World Study

In a prospective app-based observational study in the UK involving over 600,000 vaccinated individuals (partial and complete), systemic side effects were reported in 13.5% after the first dose of the Pfizer vaccine, 22% after the second dose and 33.7% after the AstraZeneca vaccine. This rate is much lower than occurred in the trials. Local reactions were in the range of 60-70%. Many patients express reluctance to get the vaccine because of fear of systemic effects. You can use this information to reassure them. Systemic effects were 2.9 times higher after the first dose in those previously infected, but that is still less than 40% of patients who have systemic side effects. In a subset of vaccinated subjects, 3,106 of 103,622 vaccinated subjects subsequently tested positive for COVID-19 compared to 50,340 of 464,356 unvaccinated individuals.
 
CDC COCA Webinar on Janssen (J&J) Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS)

Through April 21, data from VAERS shows 15 cases of TTS out of 8 million doses of vaccine. All are females, with 13 out of 15 patients between the ages of 18-49. Of the 3.99 million doses given to women, the incidence of this complication was 5.2/1,000,000 for ages 18-29 and 11.8/1,000,000 for ages 30-39. Twelve had cerebral venous sinus thrombosis (CVST), 10/15 had platelet count <50,000 and there have been three deaths. The CDC is investigating an additional two cases reported since then. VAERS is a passive surveillance system. The active surveillance system, Vaccine Safety Datalink, found 11 cases of venous thrombosis/pulmonary embolus out of 142,222 vaccine doses, but none of these had thrombocytopenia. Background incidence of CVST is 14.5-28.5/million people and higher in females ages 18-49, but rarely associated with thrombocytopenia, and only occurring in <0.1% of hospitalized COVID-19 patients. TTS after the AstraZeneca vaccine has occurred in 169 cases (10/1,000,000) in the EU and 168 cases (7.9/1,000,000) in the UK. Take-home message: This complication is rare. Avoid Janssen vaccine if history of TTS [e.g., heparin-induced thrombocytopenia (HIT)]. Risk factors for VTE unlikely to be associated with an increased risk of TTS, including pregnancy and oral contraceptive use. Do not stop ASA or anticoagulants before vaccination.
 
Have a high index of suspicion in someone who presents with severe headache, visual changes, abdominal pain, nausea/vomiting, backache, shortness of breath, chest pain, leg pain or swelling 6-13 days after vaccination. Work-up should include CBC with platelet count, imaging as indicated and a PF-4 HIT ELISA. Do not treat with heparin unless HIT testing negative.

The CDC's Clinician Outreach and Communication Activity (COCA) webinar from April 27 can be viewed here.
 
Vaccine Efficacy in Those >65 Years of Age

In a multi-state network of U.S. hospitals during January-March 2021, receipt of Pfizer-BioNTech or Moderna COVID-19 vaccines was 94% effective against COVID-19 hospitalization among fully vaccinated adults and 64% effective among partially vaccinated adults aged 65 years and older.
 
Vaccine Response in Pregnancy

This small study looked at vaccine response in pregnant compared to non-pregnant women and those with previous infection, and found that the response to the mRNA vaccine was equal in pregnant women compared to non-pregnant women and greater than the response following infection. In a very small number of patients who had delivered, antibodies were also found in umbilical cord blood and breast milk.
 
Vaccine Response in Those With Immune Deficits

A prospective observational study in a small group of cancer patients noted that after one dose of the Pfizer vaccine, 38% of patients with solid cancers (21/56) had positive antibody titers and 18% (8/44) with hematologic cancer, compared to 94% (32/34) without cancer. These numbers did go up in the even smaller number of patients who had samples 2 weeks after a second dose of vaccine: 95% (18/19) with solid cancer and 60% (3/5) with hematologic cancer, compared to 100% without cancer.

The NIH just announced a study assessing how people with immune system deficiencies or dysregulations respond to COVID-19 vaccination. The study will enroll participants 16 years of age and older, and potential participants can be referred by healthcare providers. All study visits will be conducted in person at the NIH Clinical Center or remotely. Participants can be enrolled before or after vaccination, and can have received any of the approved vaccines.
 
Updated CDC Guidelines for the Fully Vaccinated

This guidance was updated on April 27. The most recent change was that fully vaccinated people can gather or conduct activities outdoors without wearing a mask except in certain crowded settings and venues. If you travel in the United States, you do not need to get tested before or after travel or quarantine after travel. There are still restrictions on returning to the United States after international travel.
 
Facial Paralysis After Vaccination

During the pivotal trials of mRNA vaccines, there appeared to be a preponderance of cases of facial paralysis in the vaccine group compared to the placebo group, although the rate of such reactions did not exceed the expected background rate. This disproportionality analysis using the WHO Pharmacovigilance Database found that mRNA vaccines did not display a signal for facial paralysis, after analyzing 320 million doses.

COVID-19 Infection

New Review on COVID-19

This article in press in the American Journal of Respiratory and Critical Care Medicine is a good update on COVID-19, and covers pathophysiology, clinical treatment and societal impact.
 
Re-infection

A retrospective chart review based on coded diagnoses noted that re-infection was identified in 0.7% (95% CI 0.5-0.9%) of 9,119 patients who underwent serial tests in healthcare facilities in the United States between December 2019 and November 2020. Mean period between initial and re-infection was 116 +/- 21 days. Asthma (OR 1.9, 95% CI 1.1-3.2) and nicotine dependence/tobacco use (OR 2.7, 95% CI 1.6-4.5) were associated with re-infection. COPD was also associated with re-infection to a similar degree as asthma, but not mentioned by the authors.
 
Persistent Problems After Acute COVID-19 in Patients With Mild-Moderate Disease

This study in Georgia on non-hospitalized patients 1-6 months after diagnosis noted that 69% had one or more outpatient visits during this time period. Two-thirds had a visit for a new primary diagnosis. Symptoms potentially related to COVID-19 were common new visit diagnoses.
 
An excellent review in a large VA population on COVID-19 sequelae can be found here.

Disparity Research
 
NIH Will Use American Rescue Plan Funds to Research Disparities

To bolster research to help communities disproportionately affected by COVID-19, the NIH is funding $29 million in additional grants for the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. This funding was supported by the American Rescue Plan. The awards will provide $15 million to 11 teams already conducting research and outreach to help strengthen COVID-19 vaccine confidence and access, as well as testing and treatment, in communities of color. An additional $14 million will fund 10 new research teams to extend the reach of COVID-19 community-engaged research and outreach.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 26, 2021

Here are today's important updates:

Vaccines

ACIP and CDC Lift Pause on J&J Vaccine

  • After a thorough safety review the ACIP, CDC and FDA agree that the known and potential benefits from the J&J vaccine outweigh the rare risk of the thrombotic complications that have been reported. Use of the vaccine will resume for all people 18 years of age or over, but there is now a warning about this complication in the provider and patient information accompanying the vaccine. The European Medicines Agency (EMA) announced on April 20 that there may be a link between the J&J/Janssen vaccine and this complication, but that the risk/benefit ratio favors immunization. They are going to ask for a change in the warnings for the vaccine. As of April 23, there have been 15 cases reported in the United States, all of which occurred in women between the ages of 18-59, with symptom onset between 6-15 days following vaccination.

Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) Or Thrombosis with Thrombocytopenia Syndrome (TTS)

  • With all the press surrounding this complication, it is hard to remember that this is a very rare event, but clinicians need to be aware of possible presenting symptoms, since treatment differs from the usual approach.
  • VITT is the new term coined by hematology researchers who are investigating the unusual blood clots and thrombocytopenia that has occurred rarely after the use of adenoviral vector COVID-19 vaccines. The CDC is calling it TTS. The American Society of Hematology offers key takeaway points from their webinar on this topic. Urgent medical evaluation for VITT is indicated if any of the following develop 4-30 days after vaccination: severe headache, visual changes, abdominal pain, nausea/vomiting, backache, shortness of breath, leg pain or swelling, petechiae or purpura. Initial work-up should include CBC with platelet count and imaging for thrombosis based on symptoms, PF-4 HIT ELISA, fibrinogen, followed by emergent hematology consult.
  • Information from the ACIP meetings: Incidence of cerebral venous sinus thrombosis (CVST) in the general population is higher than after vaccination, but this is not the case for TTS. The key difference is the association with thrombocytopenia. Pathogenesis and management of TTS slides are available. TTS has not been observed after mRNA vaccination, although there were 3 cases of CVST with normal platelet counts following the Moderna vaccine. Learn more about TTS following Janssen COVID-19 vaccine.
  • This analysis of 23 patients following vaccination with the AstraZeneca vaccine reviewed the proposed pathogenesis and offers an algorithm for diagnosis and treatment. They also state that the risk after vaccination does not appear to be higher than the background risks in the general population. This issue also contained an editorial on VITT induced by all of the SARS-CoV-2 vaccines, and a response from Johnson & Johnson pointing out the results of their clinical trials and ongoing safety assessment and the differences between the two adenoviral vector vaccines. For more discussion on pathogenesis, see also pathogenesis and management of TTS.
  • The CDC will host a COCA call on the J&J vaccine and TTS on Tuesday, April 27 at 10:00 am EDT titled Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS): Update for Clinicians.

Safety in Pregnant Patients

  • Using data from the V-safe program, the CDC reviewed preliminary data on over 35,000 women who identified as pregnant after their vaccine. Injection site pain was more common in pregnant persons, but other symptoms of reactogenicity were less. Data on almost 4,000 who participated in the pregnancy registry did not show any safety signals of concern, and outcomes were similar to studies on pregnant women before the pandemic. The CDC now recommends that all pregnant women be vaccinated.

More on the Israeli Experience

  • Two months after initiation of their vaccine program, there was a 77% decline in the number of cases, 45% decline in the number of positive tests, 68% decline in the number of hospitalizations, and 67% decline in severe cases compared to peak values. Declines in the clinical measures occurred only after >50% of the population of a given age group had been vaccinated.

Update on COVID-19 mRNA Vaccine Allergic Reactions

  • The Mass General-Brigham group has published a report on 16 patients who they evaluated pre-vaccine for a history of a severe allergic reaction to a vaccine or injectable with PEG/polysorbate (8), oral PEG (4), other vaccine or injectable (3), and food, drug, venom or latex (1). Only one (oral PEG allergy) had a positive skin test to PEG and that patient tolerated the Janssen vaccine. The other 15 were ST negative and tolerated the first dose of a mRNA vaccine.

Vaccine Response in Variants of Concern

  • Most studies on vaccine response to variants have measured antibody serology. This study looked at antibody and antigen-specific memory B cells over time in 33 SARS-CoV-2 naïve and 11 SARS-CoV-2 recovered patients. A single dose of a mRNA vaccine produced neutralizing activity against the D614G variant in 50% of naïve recipients and against the B1.351 variant in 16%. This improved to 100% against the D614G variant and 96% against the B.1.351 variant after the second dose. Two doses of the vaccine were required to achieve levels of SARS-CoV-2 receptor binding domain (RBD)-specific B cells comparable to those after infection. In previously infected patients, both antibody and antigen-specific B cell levels were significantly boosted after one dose, with negligible changes after the second dose. These results are encouraging and would argue against delaying the second dose in infection-naïve individuals.

Vaccine Response in Previously Infected Patients

  • Several studies involving small numbers of patients have indicated that immune responses after a single dose of mRNA vaccine produces levels comparable to those in infection-naïve patients after two doses. This study confirmed that finding in more than 1,000 people.

Vaccine Response in Immunosuppressed

  • A previous message noted an absence of immune response to vaccination in kidney transplant patients. This study notes that chronic lymphocytic leukemia patients overall had a 39.5% antibody response rate two weeks after the second vaccine dose. The response was 79.2% in patients in remission after treatment, 55.2% in treatment naïve, and 16% in those undergoing treatment.

 Breakthrough Infections

  • Of the more than 75 million people in the United States who have been fully vaccinated, the CDC has received 5,814 reports of breakthrough infections after completion of vaccination (0.008%). 45% were over the age of 60, 29% were asymptomatic, 7% hospitalized and 1% died. Of those that died, 12% were asymptomatic or the patient died from another cause.
  • The current system for collecting this data is passive, so the numbers are very likely to be higher, but estimates for reinfection from the pivotal trials is in the range of 4-6%. Bottom-line: More evidence of vaccine effectiveness.

Clinical Practice
 
HHS Extends the PHE

  • HHS extended the Public Health Emergency (PHE) from April 20 until July 19, so all payer waivers that are in effect for the duration of the PHE will remain in effect through July 19.

2021 COVID-19 MIPS Relief Now Available

  • For the 2021 Merit-based Incentive Payment System (MIPS) performance year, CMS will once again use its Extreme and Uncontrollable Circumstances Policy to allow clinicians, groups and APM Entities to submit an application requesting reweighting of MIPS performance categories due to the current COVID-19 PHE. CMS recently posted instructions for submitting this application on the QPP website. The Extreme and Uncontrollable Circumstances Exception Application deadline for PY 2021 is December 31, 2021.

Thought For the Week
 
Years of Life Lost

  • We are all aware of the number of deaths due to COVID-19 last year. Consideration of this number makes it easier to discount some of the deaths as occurring in people who would have died anyway, and doesn’t reflect deaths in younger people. These researchers framed the pandemic in a different way, looking at “Years of Life Lost (YLL)” and determined that in 2020 mortality from COVID-19 in the United States was responsible for 4,000,000 years of life lost, years that could have been spent with friends, family, attending school or providing service to society.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 19, 2021

Here are today's important updates:
 
SARS-CoV-2 Infection

Reinfection

  • A large multi-center prospective study in the UK from June to December 2020 notes a reinfection rate of 7.6/100,000 person-days whereas the new infection rate was 57.3/100,000 person-days. The B.1.1.7 variant was causing roughly 50% of the infections in the latter part of the study period, but no evidence for increased reinfection rates were noted during that time.

Oral Infection

  • Researchers at the NIH have discovered that the SARS-CoV-2 virus does infect epithelial cells in the oral cavity, which may explain some of the oral manifestations of the disease (ageusia, oral blistering, and dry mouth), the accuracy of salivary samples for diagnosis and also that saliva may be infectious.

Children and Severe Disease

  • CDC researchers conducted a cohort study to estimate adjusted associations between demographic and clinical characteristics and severe COVID-19 among hospitalized pediatric patients during 2020. Increased association of severe COVID-19 was seen most with one or more underlying conditions, but also in those aged 2-11 and males. There was no statistically significant association between race/ethnicity or insurance type.

Long-Term Outcomes in Mild Disease

  • This Swedish cohort study examined outcomes in 1,400 healthcare workers (HCWs) with asymptomatic or mild disease compared to uninfected, seronegative HCWs. 26% of the infected HCWs reported at least one moderate to severe symptom lasting for at least two months, and 15% reported at least one moderate to severe symptom lasting eight months. Marked disruption of work life was noted in 8% and social life in 15%.

Vaccines

Thrombotic Events and Thrombocytopenia Noted After Adenoviral Vector COVID-19 Vaccines

  • Last week the FDA and CDC recommended a pause in the use of the Johnson & Johnson vaccine because of this extremely rare condition (<1/1,000,000 doses) and all 50 states have complied. Cases so far have been limited to women aged 18-48. Symptoms typically start six to 13 days after vaccination and consist of headaches, with occasional abdominal and focal CNS complaints.
  • Treatment is different for this complication compared to other thrombotic events. Pathogenesis may include platelet-activating antibodies against platelet factor-4 (PF4). The ACIP met on April 14 to review the data and determined more information is needed before a decision on the pause will be made. They will meet again on April 23 in emergency session.
  • The AMA hosted a webinar on this topic on April 13, which can be viewed here. The CDC also held a Clinician Outreach and Communication Activity (COCA) webinar on April 15, which can be viewed here.

Antibodies in Breast Milk After Maternal Vaccination

  • An Israeli study involving 84 breastfeeding women who were vaccinated for COVID-19 found “robust secretion of SARS-CoV-2 specific IgA and IgG antibodies in breast milk for 6 weeks after vaccination.” IgA appeared as early as two weeks, and IgG after four weeks. These antibodies had strong neutralizing effects. Limitations of the study: Mothers did not have serology or RT/PCR testing for COVID-19 at the time of vaccination.

Reduction in Asymptomatic Infection

  • A study of healthcare workers (N=9,000) in the UK noted that one dose of the Pfizer vaccine was associated with a four-fold reduction in asymptomatic COVID-19 infection >/= 12 days post-vaccination, from 0.8% to 0.2%.

More Real World Data

  • A report out of Israel on 596,618 vaccinated (Pfizer) people matched 1:1 with unvaccinated controls shows vaccine effectiveness to prevent documented infection at 46% for 14 through 20 days after the first dose, and 92% for seven or more days after the second dose; 57% and 94%, respectively, in preventing symptomatic COVID-19; 74% and 87% for preventing hospitalization; and 62% and 92% for preventing severe disease.

Poor Response to Pfizer Vaccine in Kidney Transplant Patients

  • A study of 101 kidney transplant patients on belatacept noted poor humoral and T-cell response to the Pfizer vaccine after two doses. This may have implications for other solid-organ transplant patients.

Therapeutics
 
Baricitinib Plus Remdesivir

  • A double-blind, randomized placebo-controlled trial evaluated the antiviral remdesivir in combination with the Janus Kinase inhibitor baricitinib in hospitalized adults with COVID-19 and found that the combination was more effective than remdesivir alone, particularly for patients receiving high-flow O2 or noninvasive ventilation.
  • An accompanying editorial points out that the randomized trials for therapeutics have now helped clinicians identify the clinical parameters for which individual treatments may be most effective, based on the clinical score (based on respiratory support). Remdesivir seems to work best in individuals with a score of 4 (not receiving oxygen) to 5 (low-flow O2), dexamethasone works best in those with a score of 7 (invasive ventilation) and perhaps those with scores of 5 or 6 (high-flow O2), and the combination of remdesivir and baricitinib was most effective in those with a score of 6.

Remdesivir Plus Baricitinib Compared to Remdesivir Plus Dexamethasone

  • The NIH closed enrollment of this study after interim analysis indicated that neither treatment is significantly better than the other in preventing the need for invasive ventilation in hospitalized patients.

Bamlanivimab Effective in Preventing Hospitalization

  • A retrospective case control study looked at adults with documented COVID-19 and risk factors for severe disease who received bamlanivimab (218 patients) versus those who were referred for the drug but did not receive it (185 patients). Thirty-day hospitalization rate was significantly lower among patients who received the drug (7.3% v 20.0%, RR 0.37, 95% CI 0.21-0.64, p<0.001).

Inhaled Corticosteroids

  • A randomized open-label study in 146 participants in the UK found that treatment with inhaled budesonide, 1600mcg BID, within seven days of onset of mild COVID-19 symptoms was associated with reduced likelihood of needing urgent medical care and reduced time to recovery compared to regular care.

Anti-CD14 Antibody Trial

  • The NIH announced the start of a clinical trial of a monoclonal antibody to CD14 in people hospitalized with respiratory disease and low oxygen levels due to COVID-19. This is a Phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT), and will enroll 300-350 hospitalized patients 18 years of age and older. The primary outcome measure is recovery time. CD14 has been implicated in the overamplification of the immune response to the virus.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 12, 2021

Here are today's important updates:
 
SARS-CoV-2 Infection
 
Children & COVID-19 – An Update

  • AAP and Children’s Hospital Association data as of March 25: 3,405,638 cases of COVID-19 have been reported, 13.4% of all cases. There were 64,029 new cases from March 18-March 25, children represented 19.2% of all new cases. Hospitalization in 1.3-3.1%, mortality 0.00-0.03% of cases. In Michigan, during the last two weeks of March this year, the majority of new cases occurred in 10-19 year-olds.

Post-acute COVID-19 Syndrome

  • This term coined by Dr. Fauci is the new name for COVID-long-haulers. There is a new review covering any organ system that can be involved and the Annals of Internal Medicine just published the results of an NIH workshop on the topic.

Rheumatalogic Disease Treatment and COVID-19

  • A retrospective single center study examined the risk of COVID-19 in patients with connective tissue disease and on different therapies for treatment. In the study of 2,315 patients in Madrid of which 41 had inflammatory rheumatic diseases, there was a higher risk of hospitalization and death in those treated with rituximab. Conversely, there was no increased risk of severe infection in those treated with anti-TNF medications.

Reinfection Risk Post-COVID-19

  • In a population-level observational study, individual-level data was collected from the Danish Microbiology Database for all persons who had a PCR test for SARS-CoV-2 between February 26 and December 31, 2020. Over 500,000 tests were done during that time period. 80% protection against re-infection was seen in those under 65 years of age, in contrast to 47% in those 65 and older. Healthcare workers had a two-times higher risk of reinfection.

Diagnostics
 
Home Testing Initiative

  • The CDC and NIH have partnered to launch a “Say Yes! COVID Test” campaign. It will be launched in two communities in North Carolina and Tennessee where there will be access to free home rapid antigen COVID-19 testing kits that can be used at home three times per week for one month. This pilot will attempt to determine if frequent home testing can reduce viral transmission of disease in communities.

Therapeutics
 
Remdesivir Treatment

  • Final results of the double-blind, randomized, placebo-controlled trial of remdesivir in hospitalized adults with COVID-19 showed that remdesivir was superior to placebo in shortening the time to recovery.

Vitamin D and COVID-19

  • A JAMA Network study published online in February showed that a single high dose of vitamin D had no beneficial effect on hospital length of stay in patients with moderate to severe COVID-19. Another study in JAMA Network Open that was published online in March noted that the risk of acquiring COVID-19 infection was 2.64-fold higher in Black individuals with vitamin D levels in the 30-40ng/ml compared to White individuals with similar vitamin D levels. The authors suggest that randomized clinical trials are needed to determine if supplementation of vitamin D for Black individuals might reduce infection risk.

Vaccines
 
Moderna Vaccine Six-Month Data

  • In an ongoing Phase I trial of 33 healthy adults, binding and neutralizing antibodies elicited after the second dose of mRNA1273 persist at least six months as assessed by three distinct serologic assays.

Pfizer Vaccine Antibody Response in Those Previously Infected With SARS-CoV-2

  • In a cohort study of 1,090 patients, "spike-specific IgG antibody levels and ACE2 antibody binding inhibition responses elicited by a single vaccine dose in individuals with prior SARS-CoV-2 infection (n = 35) were similar to those seen after two doses of vaccine in individuals without prior infection (n = 228)." Post-vaccination symptoms were higher with the first dose of the vaccine in those that had previously had COVID-19, but were similar with the second dose of the vaccine in both groups.

AstraZeneca Vaccine and Thrombotic Thrombocytopenia

  • One to two weeks post vaccination with ChAdOx1 several cases of moderate to severe thrombocytopenia and thrombosis emerged. These patients were seen to have platelet factor 4 (PF4)–heparin antibodies WITHOUT previously receiving heparin. This clinically appears similar to autoimmune heparin induced thrombocytopenia. Complications of the thrombosis can be seen in the brain or abdomen five to 20 days after vaccination. ELISA to detect PF4–heparin antibodies should be performed in cases suspected of this disease. High dose IVIG can be used to raise the platelet count and reduce hypercoagulability. Read the paper.

Vaccine Hesitancy

  • The Kaiser Family Foundation (KFF) continues to follow public opinion on COVID-19 vaccination. Their March 30, 2021, release demonstrates an increase in enthusiasm for the vaccine across all ethnicities. The latest data show 61% of adults being vaccinated or intending to do so, while only 13% say they definitely will not get the vaccine (the "definitely will not" percent is unchanged since December). Importantly for practitioners, the KFF tested a number of statements to see which led participants in the "wait and see" group to most likely say they would get vaccinated. "Vaccines are nearly 100% effective at preventing hospitalization and death from COVID-19" was the "most impactful" statement, followed by "scientists have been working on the technology used in the new COVID-19 vaccines for 20 years", "more than 100,000 people from diverse backgrounds took part in the vaccine trials", "vast majority of doctors who have been offered the vaccine have taken it", and "there is no cost to get the vaccine". Notably these statements only swayed those in the "wait and see" category, but had no impact on the "definitely not" group. The complete report can be found here.

Clinical Practice
 
CMS Resources for Telehealth

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 5, 2021

Here are today's important updates:

More on Real World Effectiveness of Pfizer and Moderna Vaccines 

  • The MMWR from March 29 reports on prospective cohorts of patients who completed weekly SARS-CoV-2 testing for 13 weeks starting on the first day of vaccine administration. There was also weekly surveillance of symptoms. The majority of the 3,950 subjects were White, female and between the ages of 18-49. 87.3% of PCR-confirmed infections were symptomatic. The incidence rate of PCR-confirmed infections = 1.38/1,000 person-days before vaccination, 0.19/1,000 person-days between first and second dose, and 0.04/1,000 person-days after being fully vaccinated. Estimated adjusted vaccine effectiveness of full immunization was 90% (95% CI 68-97%), and 80% after partial vaccination (95% CI 59-90%). Since all subjects were routinely tested, these effectiveness numbers also apply to asymptomatic infection.

CDC Updates Travel Recommendations for the Fully Vaccinated

  • Based largely on the data published in the above item, the CDC now states that fully vaccinated people can travel safely without needing testing before or after travel, and they also do not need to self-quarantine after travel. The testing applies to domestic travel. For international travel, no testing is needed before, but it may be required upon return.

Other Vaccine News

  • The Pfizer mRNA vaccine shows 100% efficacy in a trial in 12-18 year-old subjects. (Caution: press release, numbers could change.)
  • In a press release from April 1, the Pfizer vaccine was 91.3% effective after six months, 100% effective against severe disease, and 100% effective in preventing cases in South Africa where B.1.351 is prevalent. This data comes from additional analysis of their vaccine trial, with six months post-second dose data. This has not been peer-reviewed and the South African data represents a small sample of participants.
  • In post-hoc analysis, the AstraZeneca vaccine showed 70.4% efficacy against the B.1.1.7 variant.
  • Viral load was lower in those infected after receiving the first dose of the Pfizer vaccine in data from Israel.

Immune Response to Variants of Concern

  • In a press release issued on March 30, the NIH announced results of a small NIAID study in 30 previously infected individuals. Results of the study showed that SARS-CoV-2-specific CD8+ T cell responses remained largely intact and could recognize virtually all mutations in the variants studied [B.1.1.7 (UK), B.1.351 (South Africa) and B.1.1.248 (Brazil)]. It is important to remember that details about the exact levels and composition of antibody and T cell responses needed to achieve immunity is still unknown.
  • The published article can be found here.

Moderna Begins Variant Vaccine Trial

  • The NIH announced on March 31 that Moderna has developed a vaccine called mRNA-1273.351 and is going to start a Phase 1 trial to determine safety and immunogenicity in adult volunteers. The study is funded by the NIAID, and will study subjects who have already received the mRNA-1273 vaccine and also those who have not been vaccinated. Previously vaccinated volunteers will be randomized to receive either a single booster dose of mRNA-1273.351 or a combination of mRNA-1273 and mRNA-1273.351. Unvaccinated subjects will be randomized for a dose-ranging study in various regimens.

Should I Check Antibody Titers After Vaccination?

  • From the AAAAI's Ask the Expert: The current mRNA COVID-19 encodes for the spike protein. One needs to have an assay specifically designed to detect IgG directed against the spike protein to see a positive response to a vaccination. Please review the enclosed CDC guidance. Specifically the CDC states that “Antibody testing is not currently recommended to assess for immunity to COVID-19 following COVID-19 vaccination or to assess the need for vaccination in an unvaccinated person. Since vaccines induce antibodies to specific viral protein targets, post-vaccination serologic test results will be negative in persons without history of previous natural infection if the test used does not detect antibodies induced by the vaccine.”

Transmission

  • Schools: The CDC adjusted its guidelines for schools to allow physical distancing >/= three feet when six feet is not possible in the classroom setting, but continued to recommend six feet distancing in other situations. Of course, universal masking and handwashing is still recommended. Several other studies recently mentioned in our messaging plus these continue to show that the school environment is not a significant source of transmission of COVID-19. School sports are another story, however. Three studies the CDC used to make that change can be found herehere and here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, March 29, 2021

Here are today's important updates:

NIAID Statement on AstraZeneca Vaccine

  • In the latest interim analysis of data (after DSMB comments), AstraZeneca states that their vaccine was 76% effective against symptomatic disease and 100% effective against severe or critical disease. The revised analysis notes efficacy of 80% for those over 65 years old.
  • We should remind our patients that despite this widespread news, authorizations and guidelines for use of this vaccine in the United States will be determined by the FDA and CDC after thorough review of the entire data by independent advisory committees.

ACP/Annals Forum on COVID-19 Vaccine: Practical Clinical Considerations

  • The video can be viewed here. Several infectious disease and epidemiology experts discuss considerations for the future now that the vaccines are here.

Real World Effectiveness of Vaccines

  • We know the efficacy of the vaccines in the clinical trials, but what is the experience in the real world? In this study from Israel, a two-campus health center employing 6,680 people evaluated the rate of positive COVID-19 tests in healthcare workers (HCWs) from the start of vaccinations for seven weeks, and found a steady reduction in incidence after vaccination from 9.4/1000 at week one after vaccine to 0.4/1000 two weeks after the second dose. The numbers of HCWs who did not receive a second dose was low, so the only comparable time point was at four weeks, when the rate in those who received a second dose was 1.4/1000 compared to 13.3/1000 in those who did not. Importantly, 80% of the new cases at that time in Israel were due to the variant B.1.1.7.
  • In California in early December before they started vaccinations, the University of California, San Diego (UCSD) mandated testing of asymptomatic HCWs weekly and the University of California, Los Angeles (UCLA) instituted voluntary testing for asymptomatic HCWs on December 26. They both started vaccinations on December 16. There were 36,659 who received their first dose and 28,184 the second. The absolute risk for testing positive after vaccination was 1.19% at UCSD and 0.97% at UCLA. The majority (270/379) tested positive within two weeks after the first dose and only eight tested positive 14 days after the second dose.
  • Data from the University of Texas Southwestern show that 2.61% of unvaccinated employees became infected, 1.82% of partially vaccinated employees became infected and 0.05% of fully vaccinated employees became infected.
  • These results are certainly reassuring, but the effects of the variants remain to be determined. In addition, testing was not done for the entire population at all time points, and testing criteria varied among the institutions.

Vaccines Effective for Pregnant Women and Offspring

  • small study of the Pfizer and Moderna vaccines in pregnant women found that antibody titers were equivalent to those produced in non-pregnant women, higher than those produced by natural infection in pregnant women, and these antibodies were also present in umbilical cord blood and breast milk samples.

But Doc, I Heard That People Have Died After Vaccination 

  • This was the number one trending story on social media for a few weeks in January, with many sources posting about the same patients, thus amplifying the reports and potentially affecting people’s plans to get vaccinated.
  • Although facts are not often helpful in countering these beliefs, in reality among the 85 million people in the United States who have been vaccinated, less than 0.0018% have died sometime afterward. You are three times as likely to be struck by lightning. None of these deaths have been linked to the vaccines.

High Social Vulnerability Counties Have Lower COVID-19 Vaccination Coverage

  • This is compared to low social vulnerability counties, based on the CDC social vulnerability index.
  • Vaccination coverage estimates by county-level social vulnerability varied widely among states, and disparities were observed in the majority of states.

European Task Force on Atopic Dermatitis (ETFAD): Position on Vaccination in Patients on Immunosuppression or Biologics

  • This position paper was published in February of this year on vaccination of adults with atopic dermatitis being treated with systemic medication and biologics.
  • Atopic dermatitis is not a contraindication to vaccination. Systemic immunosuppressants and JAK inhibitors may attenuate the vaccination response, but none is expected for dupilumab.
  • Although there is no clear evidence to make a recommendation, based on studies with methotrexate and RA where a temporary two-week discontinuation slightly improved the immunogenicity of influenza vaccine, the ETFAD stated that clinicians may consider pausing JAK inhibitors and cyclosporine for one week after vaccination, or for two weeks with methotrexate and azathioprineAlternately, the lowest dose possible might be considered.

Remember the CDC Website Page on Vaccines

  • The CDC link for vaccines has daily updated data on the number of vaccinated individuals for both first dose and second dose, as well as a host of other useful additional information.
  • This site now allows individual physicians to sign up for administering the COVID-19 vaccines if you click on “For Healthcare Workers” and then click on “Become a COVID-19 vaccine provider”. Check with your state's Department of Health to see if they follow these guidelines.

PPE Tax Deductible

  • The IRS announced on March 26 that the purchase of PPE, hand sanitizer, and sanitizing wipes for the primary purpose of preventing infection by SARS-CoV-2 are deductible medical expenses for individuals—provided you otherwise qualify for medical deductions, and are also eligible to be paid or reimbursed under an FSA, Archer MSA, HRA or HSA. They remain a deductible expense for businesses.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, March 23, 2021

Here are today's important updates:

Vaccine News

  • Asymptomatic transmission: A retrospective cohort study on 39,156 adults across multiple U.S. states who were undergoing pre-procedural SARS-CoV-2 testing found that virus was detected in 3% of unvaccinated patients compared to 1% of participants who had received at least one dose of vaccine prior to screening. Adjusting for age, sex, race/ethnicity and location, the adjusted risk ratio for those who had received their first dose >10 days earlier was 0.49 and for those who had received their second dose >0 days was 0.27. This reduction is in line with what was reported in a small number of patients in the Moderna Phase 3 trial.
  • AstraZeneca vaccine and thromboembolic events: More than a dozen European countries suspended administration of the vaccine this past week due to thromboembolic events. Reports of pulmonary and CNS (sinus and cerebral vein) thromboembolic events and thrombocytopenia have been reported in a small number of patients among the millions vaccinated with this vaccine. The EMA does not feel that the number of events is greater than expected for the population, and announced on March 18 that the vaccine is safe and effective, but they couldn’t rule out a link between these events and the vaccine. France, Germany, Italy and Spain, as well as most of the other countries, have removed the suspension, although the top French health regulator recommended it only for those over 55, since the blood disorders were found in people younger than that, and Sweden, Denmark and Norway were awaiting further investigation.
  • AstraZeneca efficacy: The company announced that interim trial data from the United States, Chile and Peru show 79% efficacy across all age groups against symptomatic COVID-19 and 100% efficacy against severe disease. The trial involved over 32,000 patients. The vaccine was given in two doses, 4 weeks apart. No thromboembolic events were noted among the trial participants. The company will apply to the FDA for an EUA in “the coming weeks.”
  • Vaccines and variants: Two doses of the AstraZeneca vaccine showed efficacy of 10.4% against mild-to-moderate COVID-19 caused by the B.1.351 variant in a South African multicenter randomized trial. There were not enough severe cases in the trial to conclusively determine efficacy against severe disease. In a very small study involving 56 infected or vaccinated patients, neutralizing antibody was effective against the B.1.1.7 variant.
  • Payment rate: From CMS: Effective for COVID-19 vaccines administered on or after March 15, 2021, the national average payment rate for physicians, hospitals, pharmacies, and many other immunizers will be $40 to administer each dose of a COVID-19 vaccine. This represents an increase from approximately $28 to $40 for the administration of single-dose vaccines and an increase from approximately $45 to $80 for the administration of COVID-19 vaccines requiring two doses. The exact payment rate for administration of each dose of a COVID-19 vaccine will depend on the type of entity that furnishes the service and will be geographically adjusted based on where the service is furnished.
  • Vaccines in children: Both Moderna and Pfizer have enrolled children down to age 12 in vaccine trials, and now Moderna has announced a Phase 2/3 trial in children ages 6 months to 12 years, beginning with a dose-ranging study then moving into a randomized, placebo controlled trial. The company plans to enroll 6,750 children.
  • Vaccines in immunosuppressed patients: In this study, only 17% of solid organ transplant recipients developed antibody responses 20 days after a single dose of mRNA vaccine.

AMA Resources to Boost Vaccine Confidence

  • Counseling patients about the COVID-19 vaccine is consuming a lot of our time lately. To help, the AMA has a list of resources for practitioners. Called the “It’s Up to You” COVID-19 vaccine education initiative, it includes websites for the public in English and Spanish on vaccine information, messaging guide for physicians, physician FAQs, COVID-19 vaccine script for patient inquiries, and a video series including healthcare leaders addressing questions about vaccines.

Reinfection Rate

  • This study from Denmark compared infection rates during the spring of last year to fall of this year. Out of 11,068 people who had tested positive during the spring surge, only 72 (0.65%) tested positive again during the second surgeProtection was calculated at 80.5%. In an alternative cohort analysis, among those 65 and older, observed protection was 47.1%. There was no evidence of waning protection. Results were similar for 3-6 months follow-up versus 7 or more months of follow-up.

Long-Haul COVID-19 Now Called PASC

  • Dr. Anthony Fauci coined this new term recently during a White House news conference. Post Acute Sequelae of COVID-19 (PASC) was studied in a prospective uncontrolled cohort of 478 survivors of COVID-19 4 months after hospitalization. 51% reported at least one new symptom. Most common new symptoms at 4 months included fatigue (31%), cognitive symptoms (21%) and new-onset dyspnea (16%).

Testing

  • Antigen tests: Previous studies have suggested that antigen tests had low sensitivity in asymptomatic patients, but others have noted good sensitivity compared to RT/PCR. Two studies using different assays (here and here) noted that the sensitivity does depend on the viral load as measured by RT/PCR cycle thresholds. The sensitivity of the assays can be up to 90% or more with high viral loads. The real-world problem is that while symptomatic patients are more likely to have higher viral loads, that isn’t something a clinician could know when the test results come back negative.
  • Serology: A new, excellent resource is the AHRQ Evidence-based Practice Center’s Antibody Response Following SARS-CoV-2 Infection and Implications for Immunity: A Living Rapid Review. There is much we don’t know and much to learn about COVID-19 serology, and how to use this tool in practice (key message: not ready for primetime). While the majority of adults produce IgM and IgG antibody after infection, about 6-10% do not. Reasons for the absence of response are not clear, but may relate to the severity of disease. IgG levels persist for at least 120 days, and neutralizing antibodies for at least 152 days. Studies to date have not established the relationship between the development of antibodies and the risk of reinfection, although studies suggest the presence of antibodies is associated with lower risk.

Treatment Update

  • A recent press release from Eli Lilly presented new data from the BLAZE-1 Phase 3 study comparing bamlanivimab (LY-CoV555) 700mg plus etesevimab (LY-CoV016) 1400mg in high-risk adolescents and adults with mild-to-moderate COVID-19 to placebo, demonstrating 87% reduction in hospitalizations and deaths. This treatment has received an EUA from the FDA for non-hospitalized COVID-19 patients at high risk for more severe disease. Prior results from another cohort in the same study showed that higher doses of both drugs reduced the risk of these events by 70%. So far this information is not yet available in a peer-reviewed journal.
  • In another press release, Vir Biotechnology and GSK announced that their Phase 3 trial on a monoclonal antibody treatment VIR-7831 was stopped early given an 85% reduction in hospitalization or death in adults at high risk for hospitalization. This was based on an interim analysis of data from 583 patients enrolled in the trial. These companies plan to submit an EUA application. The companies also announced the results of another study indicating that this monoclonal maintains activity against the virus variants of concern, which was submitted for publication in bioRxiv (pre-print, not peer-reviewed site).
  • Taking another approach to therapy, this study looked at mavrilimumab, a monoclonal antibody to the GM-CSF receptor, in hospitalized patients with COVID-19 pneumonia, hypoxemia and elevated c-reactive protein, and did not find any significant difference in the proportions of patients alive and off oxygen therapy at day 14.

Decontaminating N95 Masks - What Works Best

  • A review of 42 studies in JAMA reported that ultraviolet germicidal irradiation, moist heat, and microwave-generated steam processing of filtering facepiece respirators are effective means for decontamination and are simple to implement.

Signs Your N95 Masks May Be Counterfeit

  • From AMA News: According to NIOSH, here are seven signs of counterfeit respirators that physicians and staffers at medical groups and health systems should look for: 1) No markings at all on the filtering facepiece respirator. 2) No approval number on filtering facepiece respirator or headband. 3) No NIOSH markings. 4) NIOSH spelled incorrectly. 5) Presence of decorative fabric or other decorative add-ons. 6) Claims of approval for children—NIOSH does not approve any type of respiratory protection for children. 7) Filtering facepiece respirator has ear loops instead of headbands.

CMS Updates COVID-19 Provider Toolkit and FAQs

  • Toolkits for vaccine providers and FAQs on FFS billing were updated the first week of March and can be accessed here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, March 15, 2021

Here are today's important updates:

So Is Asthma A Risk Factor for Severe Disease?

  • We all continue to get questions about asthma and COVID-19 from our patients. Earlier in the pandemic, they were concerned about getting sick and now they are concerned about which vaccine tier they should be in.
  • By early October of this past year, there have been over 110 publications including 4 meta-analyses that clearly demonstrate that asthma is not a risk. Similar findings are noted in the 10 or so papers published since then, and at least a few have demonstrated protection for those with asthma.
  • At this point, the answer is no.

Vaccine Anaphylaxis - Real World Data

  • In a research letter published in JAMA Online First on March 8, the group from Mass General Brigham reported on their prospective study of 52,805 employees who received their first dose of an mRNA vaccine. Acute allergic reactions were reported by 1,365 employees (2.1%), and anaphylaxis was confirmed in 16 employees (0.025%)94% of these were female, 10 had a prior allergy history and five had an anaphylaxis history. One patient was admitted to the ICU, all recovered. The incidence rate of anaphylaxis in this study was 2.47/10,000 vaccinations, which is higher than that reported via passive reporting measures (VAERS, Vsafe) but still rare.

B.1.1.7 Variant More Deadly

  • This variant was associated with an overall 1.6-fold increase in risk of death compared to previously circulating variants, with the increase noted from days 15-28 after infection. This corresponds to an increase in deaths from 2.5-4.1 per 1,000 cases. Read more.

Inpatient Treatment Updates

  • Baricitinib plus remdesivir in hospitalized adults was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with COVID-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. The study can be found here.
  • Anti-IL6 monoclonal antibodies: Two separate randomized trials using tocilizumab and sarilumab in patients with moderate-to-severe hospitalized COVID-19 patients showed no significant difference compared to standard care or placebo in improvement in the course of the disease. The studies can be found here and here.

NIH Highlights Comorbidities Associated With COVID-19 Hospitalization

  • A study published in late February in the Journal of the American Heart Association estimated that in the 900,000 hospitalizations that occurred in November 2020, 30% were attributable to obesity, 26% to hypertension, 21% to diabetes and 12% to heart failureObesity affected hospitalization similarly across age groups, whereas the other three were more likely in older patients.
  • In another study looking specifically at the degree of obesity among 148,494 adults diagnosed with COVID-19 between March and December of 2020, individuals with a BMI near the threshold between healthy weight and overweight generally had the lowest risk for hospitalization, ICU admission and death. Obesity was a particular risk for hospitalization and risk in those <65 years old. Individuals in the highest BMI category (>/= 45 kg/m2) had a 2-fold greater risk of death and 1.6-fold greater risk of hospitalization. Underweight individuals had a 20% greater risk for hospitalization.

T Cell Immune Response to COVID-19

  • Functional responses were retained 6 months after initial infection in this study of 100 convalescent donors. Responses were characterized by predominate CD4+ T cells with strong IL-2 cytokine expression. Responses were higher if the initial infection was symptomatic and correlated with peak antibody levels.

Transmission

  • Schools: Testing of asymptomatic students and staff in New York City public schools in the fall of 2020 noted that the incidence of COVID-19 was about 60% lower compared to the city population. 0.4% of 234,132 persons were positive on testing, rates were highest in K-8 staff and elementary students. Secondary attack rate was 0.5%, likely from a staff person. Read more.
  • retrospective cohort study of 537,336 students and 99,390 staff among 351 school districts in Massachusetts this fall showed that increasing physical distancing requirements from >/= three feet to >/= six feet was not associated with a reduction in COVID-19 cases if other mitigation measures were implemented.

Small Business Administration Issues Interim Final Rule With Changes to Paycheck Protection Program (PPP)

  • On December 27, 2020, the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (Economic Aid Act) was enacted, extending the authority to make PPP loans through March 31, 2021, revising certain PPP requirements, and permitting second draw PPP loans. This interim final rule allows individuals who file an IRS Form 1040, Schedule C to calculate their maximum loan amount using gross income, and removes the eligibility restriction that prevents businesses with owners who are delinquent or in default on their Federal student loans from obtaining PPP loans. Unless otherwise specified in this interim final rule, the provisions of this interim final rule are effective March 4, 2021. Details can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, March 8, 2021

Here are today's important updates:

CDC Issues New Interim Guidelines for Fully Vaccinated Persons in Non-Healthcare Settings

  • Released on March 8, the CDC now states that fully vaccinated persons can: visit with other fully vaccinated people indoors without wearing masks or physical distancing, visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing, and refrain from quarantine and testing following a known exposure if asymptomatic. In all other circumstances, they should continue to follow current mitigation recommendations and avoid medium and large in-person gatherings.

Delayed Local Reactions After Moderna Vaccine

  • In this NEJM paper, Blumenthal and colleagues report on 12 patients with delayed large local reactions. Median onset was on day eight after the first dose and had a variable appearance, many of which were large indurated erythematous plaques. Some had concurrent systemic symptoms. Treatment varied from antihistamines to steroids (oral or topical) with resolution over a median of six days. Skin biopsy from another patient supported a delayed-type hypersensitivity reactionAll 12 went on to get their second dose of the vaccine, half had no reaction, while the other half had similar reactions of the same severity or less. Median onset of the reaction after the second dose was day two.
  • Data from the original clinical trials did note such a reaction in 0.8% of participants.

Patients With Mastocytosis Should Tolerate COVID-19 Vaccines

  • In correspondence to the JACI, authors from Portugal and Brigham and Women’s Hospital report on two patients with systemic mastocytosis and a history of anaphylaxis who tolerated the Pfizer mRNA vaccine with pretreatment, without any adverse effects. They go on to recommend pretreatment with H1 and H2 antihistamines one hour before, and montelukast one and 24 hours before vaccination, and that vaccination be given in a hospital setting.

Is One Dose of Vaccine Enough for People Who Had COVID-19?

  • In a Lancet study published on February 25, anti-S (spike) antibodies following the first dose of the Pfizer vaccine in participants who were seronegative were equivalent to those with natural infection, while the titers in seropositive participants were 140-fold higher than pre-vaccine titers. There were 51 participants in the study. Another study in the same issue involving 71 participants showed similar results. In this study, however, those with T-cell response indicating prior infection, but negative serology for anti-S antibodies, had titers post-vaccination that were less than those with positive serology, but greater than those with no prior infection.
  • third study was published online in JAMA on March 2. This study in 59 participants showed that the antibody and neutralization titers 14 days after the first vaccine dose were several fold higher in those that had previous infection, compared to those who did not. Problems with this study included a poor antibody response after vaccination in those without previous infection.
  • ACIP doesn’t currently recommend this approach based on conversations published in AAP News this week. Also, in a given individual who has survived COVID-19, the level of antibodies is unknown. It would not be practical to check serology before vaccination, and we don’t know what level of anti-S antibodies would warrant skipping the second dose.

Household Transmission Rate

  • There have been several studies looking at household transmission rate, but this large study done in a Boston healthcare system (Massachusetts General Brigham) that involved 7,262 individuals who were COVID-19 positive and 17,917 household contacts, found the overall infection risk was 10.1%. Independent factors significantly associated with higher transmission were age >18 years and multiple comorbid conditions. This was done in the spring of 2020, before the more transmissible variants were present.

Persistent Viral Shedding

  • In this study of 109 patients with mild-to-moderate COVID-19 who underwent serial RT/PCR testing, the majority were found to have continued viral RNA shedding for more than 10 days, but cultures performed in 35 of the patients did not reveal replication competent viruses. This provides some evidence that individuals with mild-to-moderate COVID-19 are less likely to be infectious beyond 10 days after onset.

Convalescent Plasma Ineffective

  • meta-analysis of randomized clinical trials comparing COVID-19 patients treated with convalescent plasma to controls, involving almost 12,000 patients, found no significant differences in all-cause mortality, length of stay or mechanical ventilation. Most of the participants were inpatients, not all of whom were requiring supplemental oxygen. Four of the trials used high-titer convalescent plasma. Limitations of the study are that only four of 11 studies were published in peer-reviewed journals, five were preprints and two were press releases. The largest study (RECOVERY trial) included 10,000 of the 12,000 participants and only had data from a press release.
  • On February 4, the FDA revised the EUA for convalescent plasma, authorizing only high-titer plasma for hospitalized patients early in the course of the disease, as well as those hospitalized with impaired humoral immunity.

New Guidance on Coverage of COVID-19 Testing, Vaccination

  • In guidance released late last week, CMS—along with the Departments of Labor and the Treasury—issued guidance clarifying that “private group health plans and issuers generally cannot use medical screening criteria to deny coverage for COVID-19 diagnostic tests for individuals with health coverage who are asymptomatic, and who have no known or suspected exposure to COVID-19” and that “testing must be covered without cost sharing, prior authorization, or other medical management requirements imposed by the plan or issuer.” The guidance also discusses how providers can be reimbursed for COVID-19 testing and vaccinations for the uninsured. Read more in the CMS press release.

HCPCS CPT Codes for Vaccines

  • Codes for all the vaccines themselves and administration codes can be found here. These also include codes for the yet-to-be-approved AstraZeneca vaccine.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, March 2, 2021

Here are today's important updates:

Janssen (Johnson & Johnson) Vaccine Receives EUA

  • This vaccine, Ad26.COV2.S, is a replication-incompetent adenovirus type 26 vectored vaccine encoding a stabilized variant of the SARS-CoV-2 S protein (spike) for individuals 18 years of age or older. It is a single dose vaccine. The EUA application included data from 39,321 randomized participants.
  • This is information from the FDA briefing document. Vaccine efficacy (VE) against laboratory-confirmed moderate-to-severe/critical COVID-19 across all geographic areas in which the trial was conducted was 66.9% at least 14 days after the dose and 66.1% after 28 days. VE against severe/critical COVID-19 was 76.7% after 14 days (68.5% in those 60 and older) and 85.4% after 28 days (70.3% in those 60 or older). There were two cases in the vaccine group that required hospitalization after 14 days and zero after 28 days, and 29 in the placebo group (16 after 28 days). There were seven deaths in the placebo group and zero in the vaccine group. VE for symptomatic COVID-19 of any severity was 66.5%. In general, VE across subgroups (age, comorbidity, race and ethnicity) appears to be similar. There were no COVID-19 cases requiring medical intervention 28 days or more after vaccination among participants 60 years of age or older with medical comorbidities in the vaccine group. Trial participants included 45.1% Hispanic/Latino, 17.2% Black, 8.3% American Indian or Alaskan Native, 3.5% Asian.
  • There was country-to-country variation in VE estimates and the predominant strains varied in different countries (Wuhan-H1 variant in the United States, B.1.351 in South Africa and P.2 in Brazil). VE in the United States was 72% with 44.1% of the participants, 61% in Latin America (38% of participants) and 64% in South Africa (15% of participants).
  • Common adverse events included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%), were predominately mild and moderate, and were less common in those 60 years of age and older. A numerical imbalance was seen in non-serious urticaria events (five in vaccine group, one in placebo) within seven days following vaccination, thromboembolic events (15 versus 10) and tinnitus (six versus zero). Non-fatal serious adverse events were infrequent and balanced between study groups. One serious event of a hypersensitivity reaction, not classified as anaphylaxis, beginning two days following vaccination was likely related to receipt of the vaccine.
  • VE against asymptomatic infection, defined as +PCR and/or serology without previous symptoms, was 20% from day one through 29, but 74.0% after day 29. The FDA urges caution in interpreting this data because only a limited number of participants had serology done by the data cut-off date.

Other Vaccine News

  • Real world effectiveness: In a cohort study of vaccinated versus unvaccinated controls in Israel, involving almost 600,000 individuals in each group, the Pfizer BioNTech vaccine’s estimated effectiveness at 14-20 days after the first dose was 46% for any infection, 57% for symptomatic infection, 74% for hospitalization, and 62% for severe disease. At 7 or more days after the second dose, the efficacy was 92%, 94%, 87%, and 92% respectively for the same outcomes. Effectiveness for preventing death after the first dose was 72%. In another report from Israel, the ratio of COVID-19 patients over the age of 70 requiring mechanical ventilation declined 67% compared to those under 50 from October-December 2020 to February 2021 after their national vaccination program had fully vaccinated 84% of those over 70.
  • Improved response after delayed second dose with AstraZeneca vaccine: In this study published online in Lancet on February 19, efficacy was greater when the interval between first and second dose was <12 weeks compared to <6 weeks.

Treatment

  • Monoclonal antibodies: The FDA granted an EUA for the combination of bamlanivimab 700mg and etesevimab 1400mg for the treatment of outpatients with mild-to moderate COVID-19 who are at high risk of clinical progression to severe disease and/or hospitalization. Treatment should be started as soon as possible after the diagnosis has been confirmed and within 10 days of symptom onset. The NIH COVID-19 Treatment Guidelines Panel has added this as a recommendation.

Viral Variants

  • The mutations of concern in the widely discussed SARS-CoV-2 viral variants occur in the receptor-binding domain (RBD) of the spike protein, which is also the site for binding of neutralizing antibodies. The mutations in the ACE2-interactive surface of the RBD are N501Y in B.1.1.7, K417N, E484K and N501Y in B.1.351 and K417T, E484K and N501Y in P.1.
  • In this study of convalescent plasma and monoclonal antibodies using a small number of samples of convalescent or post-vaccination serum, neutralization of the B.1.351 variant was 13-fold lower for the convalescent plasma and 7.6 to 9-fold lower for the vaccinated serum. A panel of potent single monoclonal antibodies showed a severe reduction to complete knockout of neutralization, but combinations of monoclonal antibodies were more effective. The E484K mutation appears to be the key mutation in driving this resistance to antibodies.

COVID-19 Sessions at the 2021 AAAAI Virtual Annual Meeting

The 2021 AAAAI Virtual Annual Meeting included a variety of sessions related to COVID-19:

  • Session 1705: Immune Profiling of COVID-19 Patients
  • Session 2301: The Biomedical Research Response to COVID-19: A View From the National Institute of Allergy and Infectious Disease (NIAID)
  • Session 2403: COVID-19 and Pulmonary Manifestations in Different Populations
  • Session 2705: Finding Unicorns Among Zebras: When and How to Test COVID-19 Patients for Underlying Immunodysregulatory Conditions
  • Session 3404: Immune Responses to Key Respiratory Viral Illnesses: COVID-19, Respiratory Syncytial Virus (RSV) and Rhinovirus
  • Session 3405 (Allied Health): COVID-19: The Clinical Impact on Patients with Asthma and Allergic Disease
  • Session 3406: Allergic Reactions to COVID-19 Vaccines: Separating Fact from Fiction
  • Session 3710: Turning Lemons into Lemonade: Lessons Learned from the COVID-19 Pandemic
  • Session 4512: Telemedicine During the COVID-19 Pandemic: What We Learned and Where We Go From Here

If you attended the meeting, you can access the recordings of these sessions in the meeting platform. As a reminder, attendees will have access to the platform and the ability to watch session recordings and claim credit until March 1, 2022.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, February 22, 2021

Here are today's important updates:

Vaccine News

  • Efficacy: Serum samples from 20 participants in the Pfizer trial showed a reduction of 2/3 in neutralizing activity against the B.1.351 variant (South African origin) compared to the early strains and those from the UK and Brazil. Samples from participants in the Moderna trial showed a 6.4 fold reduction in neutralizing activity against the B.1.351 variant.
  • Safety: Results of safety monitoring from VAERS and Vsafe after one month of vaccinations can be found in this issue of MMWROver 90% of reactions were non-seriousAnaphylaxis rates (4.5 per million doses) remain in range of other vaccinesFemale gender may be a risk factor for adverse reactions and anaphylaxis. 113 deaths have been reported (65% in long-term care facilities) and based on medical review do not suggest a causal relationship between vaccination and death, although not all deaths have been reviewed.
  • The WAO has just issued a statement on COVID-19 Vaccine-Associated Anaphylaxis, which is similar to CDC guidance, except they do point out that cross-reactivity between PEG and polysorbate 80 are rare, and the amount of polysorbate 80 in the AstraZeneca vaccine is the same as in influenza vaccines. They have also launched a global surveillance project and encourage providing de-identified information on patients with anaphylaxis to the vaccine at this website.
  • Pregnancy: Pfizer/BioNTech plan to start trials in pregnant women soon, with AstraZeneca and Johnson & Johnson planning similar trials in the near future.
  • Children: Trials in children 12 years and older have just recently started, expect the first data by early summer.
  • Variants: Another good viewpoint was published February 17 in JAMA Online First, written by the head of the CDC and NIAID, which reviews the 3 variants of concern (B.1.1.7, B.1.351 and P.1), current data on spread and risk for increasing cases of disease, concerns and steps to ensure that our current testing can detect disease caused by these variants, and steps to be taken to slow transmission. The authors feel strongly that current mitigation methods must be continued, including delaying travel.

Treatment

  • Interim results of the WHO Solidarity Trial published in NEJM this month showed no significant effect on mortality, reduced initiation of ventilation or hospitalization duration with treatment of COVID-19 hospitalized patients with remdesivir, hydroxychloroquine, lopinavir (with or without interferon) or interferon.
  • NIH announces enrollment in four new Phase 2/3 sub-studies under the ACTIV-2 trial for non-hospitalized adults with mild-to-moderate symptoms of COVID-19. The four agents to be studied include: SNG001, an inhalable beta-interferon (Synairgen), AZD7442, a long-acting monoclonal antibody combination that will be studied IV and IM (AstraZeneca), and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2 cell entry (Sagent Pharmaceuticals). Read further details.
  • The NIH has a “living” website page on COVID-19 Treatment Guidelineswhich has been updated as of February 11. The updated guidelines cover prevention and prophylaxis of SARS-CoV-2 infection, therapeutic management of patients with COVID-19, ivermectin, anti-SARS-CoV-2 monoclonal antibodies, and the kinase inhibitors.
  • In this article published online February 12 in JAMA Network Open, the authors compared zinc, ascorbic acid, or both versus usual care in a randomized trial in 214 adults and found no effect on length or reduction of symptoms.

Persistent Disease

  • This report from the UK indicates that about 10% of patients with ongoing symptoms 6 weeks after discharge had evidence of interstitial lung disease that responded to treatment with oral steroids.
  • In another study from Spain, less than 10% of patients followed after 2 months showed a reduction in FVC or FEV1, but 25% had a reduction in DLCO.

CDC Issues Updated Operational Strategy for Schools

  • This strategy has been updated as of February 12.
  • While emphasizing the importance of reopening schools, the guidance also emphasizes that success in preventing the introduction and subsequent transmission of SARS-CoV-2 in schools is connected to and facilitated by preventing transmission in the broader community.
  • Essential elements include mitigation strategies, indicators of community transmission, phased mitigation, learning modes, and testing and vaccination of teachers and staff when supply allows.

School Studies Confirm CDC Quarantine and School Mitigation Recommendations 

  • The CDC stated that quarantining for 10 days without testing does have a risk for transmission after this time period between 1 and 10%, and continues to prefer 14 days of quarantining.
  • Data from school testing involving 839 students in a single county in Florida showed that 7.4% of the 388 high school students may return to school with COVID-19 infection if the recommendation for 10 days of quarantine without testing is followedThe rate of potential infectiousness in elementary and middle school students was only 1.8%. Only one of 799 students who were negative at 9-14 days became positive after returning to school, and that was an infection due to a different strain. Limitations of this study relates to the different timing of testing.
  • The CDC also recommends strict mask policies, physical distancing and minimizing in-person adult interactions at school.
  • In another study in school transmission in Georgia, officials identified nine clusters of epidemiologically linked COVID-19 cases involving 13 educators and 32 students in six of eight elementary schools between December 2, 2020, and January 22, 2021. Half of the cases involved probable educator-to-educator transmission and subsequent educator-to-student transmission. All nine clusters involved less than ideal physical distancing, and five involved inadequate mask use by children. Educators were central to in-school transmission networks. Precautions should include promotion of COVID-19 precautions outside of school.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


February 15, 2021

Here are today's important updates:

Vaccines and Viral Variants

  • Sera from 20 participants who had received both doses of the Pfizer vaccine showed equivalent neutralization titers (differences of 4-fold or less) between the wild type and engineered variants that contained spike proteins from recently emerged variants, including those first described in the UK and South Africa. Neutralization geometric mean titers suggest small impacts of these mutations on neutralization by sera from vaccinated individuals. (Disclaimer: These engineered viruses do not contain all of the mutations present in the variants). Details can be found here.
  • Here's a good article on viral variants that was published online by JAMA on February 11.

CDC Updates Clinical Considerations for mRNA Vaccines

  • In an update from February 10, the CDC made new recommendations for preventing, reporting and managing mRNA vaccine administration errors, clarified contraindications and precautions, updated information on delayed local reactions, and updated quarantine recommendations for vaccinated persons.
  • Persons with a known (diagnosed) allergy to PEG or polysorbate have a contraindication to vaccination. Persons with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is PEG, another mRNA vaccine component or polysorbate, but in whom it is unknown which component elicited the immediate allergic reaction have a precaution (counseling, 30-minute observation). Deferral of vaccination and/or consultation with an allergist may be considered.
  • Vaccinated persons with an exposure to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria: are fully vaccinated (two weeks or more after the final vaccine dose), are within 3 months following receipt of the final dose, and have remained asymptomatic since the current exposure. Such individuals should continue mitigation precautions and monitor for symptoms of infection.
  • Delayed local reactions beginning a few days through the second week have been reported and are not considered contraindications to receipt of the second dose. It is unknown whether such patients will experience a similar reaction after the second dose.

Update on Anaphylaxis Following Vaccination 

  • Updated information through January 18 indicates that rates continue to decline as more doses are given. Data are from VAERS and anaphylaxis is determined based on the Brighton Collaboration case definition. As of January 18, 17,524,676 doses have been administered of both the Pfizer and Moderna vaccines, with 66 cases that met the Brighton Collaborative case definition criteria of anaphylaxis, for a rate of 4.7 cases/million doses for Pfizer and 2.5 cases/million for Moderna. Interesting characteristics of these cases: 94-100% female (don’t know the percentage of females who have been vaccinated), 89% of reactions occurred within 30 minutes, 77-84% had a prior history of allergies or allergic reactions, and 32% a history of prior anaphylaxis. 48% were hospitalized, 27% in intensive care, and 11% required intubation. No deaths have been reported. These numbers remain reassuring that anaphylaxis after vaccination is rare, but reactions can be severe.

ARIA-EAACI Position Paper on Severe Allergic Reactions to the Vaccines

  • The authors of this paper stress that the recommendations will be fluid and reflect the knowledge at the time.
  • Key points: A better understanding of the mechanism of the reactions that have occurred is urgent, allergy patients should not be generally excluded from the vaccine, observation time of at least 15 minutes, and training of vaccine sites in the proper management of anaphylaxis. If PEG sensitization is confirmed as the cause, patients should be referred to an allergist for evaluation, current guidelines excluding patients with severe allergies from vaccination (British guidelines) should be re-evaluated, patients with a suspected allergic reaction should be referred to an allergist as the application of the second dose in a specialized setting or the applications of increments of the vaccine will be feasible for the majority.

National Forum on COVID-19 Vaccine

  • The CDC will be hosting this virtual forum for practitioners focused on vaccine implementation, and people and groups that can champion vaccine uptake in communities. The Forum will take place February 22-24, with registration closing February 16. Learn more here.

Russian Vaccine Efficacy 91.6%

  • In an interim analysis of Phase 3 data involving almost 20,000 people, the recombinant adenovirus-based vaccine Gam-COVID-Vac (Sputnik V) showed an efficacy OF 91.6% by 21 days after the first dose. Observed vaccine efficacy was >87% in all age and sex subgroups, and 91.8% for those over 60 years of age. 94% of adverse effects were mild, and serious adverse events were very low and similar to placebo.

CDC Posts Mask Guidance for Improved Protection 

  • This new guidance posted on February 10 suggests ways to improve the effectiveness of masking. Details on the evidence supporting these recommendations can be found here.

Transmission

  • systematic review and meta-analysis showed that secondary attack rates (SARs) were highest within households (21%) especially if duration of exposure was over 5 days. SARs for contacts with family and friends were higher than those for low-risk casual contacts (6% vs. 1%). Estimates of SARs for asymptomatic index cases were about 7-fold lower.

Burden of COVID-19 Disease in the United States as of November 20

  • Using a combination of data from public health surveillance of reported COVID-19 cases and seroprevalence surveys (to establish underreporting values), the authors report an estimated 46,910,006 infections, 28,122,752 symptomatic infections, 956,174 hospitalizations, and 304,915 deaths.
  • This suggests that 14% of the U.S. population was infected by SARS-CoV-2 by mid-November, that the number of actual infections is about 40% higher than the reported cases, and there is a long way to go to achieve herd immunity.
  • Details of the study can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


February 8, 2021

Here are today's important updates:

Monoclonal Antibody Therapy for COVID-19

  • Bamlanivimab (LY-CoV555) from Eli Lilly initially reported successful reduction in viral load in non-hospitalized patients with mild to moderate COVID-19, but a later analysis of a larger number of patients in the same study, ironically published by JAMA on the same day as the first report, did not show a significant effect compared to placebo.
  • Combination therapy appears to be more effective. Bamlanivimab plus etesevimab did show a reduction in viral load in the same type of patient. Another monoclonal antibody cocktail (REGN-COV2) from Regeneron has also shown a reduction in viral load in a preliminary analysis.
  • These treatments have not shown effectiveness in patients already hospitalized with COVID-19.
  • There are ongoing studies on using these treatments for prophylaxis in nursing homes and in contacts of infected patients. In a press release dated January 21, Eli Lilly reported that bamlanivimab prevented symptomatic COVID-19 by 57% in nursing home residents and staff, and by 80% in residents. There were no COVID-19 deaths in the treated residents, compared to four deaths in the placebo group.
  • These treatments must be given in an infusion center, which has become somewhat of a barrier during the pandemic, but may offer an opportunity to reduce future COVID-19 morbidity and hospitalization. It is important to note that they do not have an EUA yet for prophylactic therapy. Medicare and most insurances have decided to cover these without co-pay or co-insurance.

High-Titer Convalescent Plasma for COVID-19

  • small study on the use of early high-titer plasma therapy in 160 adults age 65 or over with pre-existing conditions, or 75 and over without any pre-existing conditions, noted a 48% relative risk reduction for severe respiratory disease.
  • retrospective study that examined the anti-SARS-CoV-2 IgG antibody levels in convalescent plasma used to treat 3,082 hospitalized adults with COVID-19 found that treatment with high-titer convalescent plasma was associated with a lower rate of death at 30 days than low-titer convalescent plasma therapy, in patients who were not being mechanically ventilated.
  • The FDA has revised the EUA for convalescent plasma effective February 4. The EUA is now limited to high-titer convalescent plasma, for treatment of hospitalized patients early in the course of disease and those hospitalized with impaired humoral immunity. The EUA also lists those lab assays that are authorized for qualifying the plasma as high titer.
  • There are ongoing studies looking at the use of high-titer convalescent plasma as prophylaxis in people with predisposing conditions and COVID-19 contact.

More on Virus Variants

  • These points come from a summary on virus variants from the University of Washington Alliance for Pandemic Preparedness.
  • Naming Conventions: As the number of variants become more prevalent and widespread, it is important to move away from naming based on geographic origin. The problem is that there are multiple categorizations of these variants across research and public health organizations. Without going into a lot of detail on the naming conventions, here is a listing of the most referenced strains with their aliases:

- Lineage B.1.1.7 (aka variant 20I/501.Y.V1 or VOC 202012/01) first identified in the UK
- Lineage B.1.351 (aka variant 20H/501Y.V2) first identified in South Africa
- P.1 variant (aka variant 20J/501Y.V3, branch from B.1.1.28 lineage) first identified in Brazil
- CAL.20C variant first identified in southern California

  • Transmission: B.1.1.7 is found in 90% of samples across England, has a 25-40% higher attack rate, and 10-times higher affinity for the ACE2 receptor.
  • B.1.351 is the predominant strain now in South Africa, but has been found in the United States. It's estimated to be more transmissible, but less quantified than B.1.1.7.
  • P.1 variant is also estimated to be more transmissible and may lead to re-infection.
  • CAL.20C is showing increasing dominance in southern California, coinciding with the increased positivity in that region.
  • Implications for Re-Infection and Vaccine Efficacy: B.1.351 and P.1 mutations reduce neutralization by convalescent serum up to 10-fold, by most monoclonal antibodies and sera from vaccinated persons (6 to 8-fold). Cases of re-infection have been reported for all these variants. All vaccines approved or in Phase 3 trials have shown slight reduction in neutralization for the B.1.1.7 variant, and more so against the B.1.351 variant, although still over 50% efficacy.
  • Clinical Severity: Most of the data is on the B.1.1.7 variant out of the UK, which is conflicting, with some studies suggesting increased mortality, some finding no association and one showing equal likelihood of being asymptomatic.

AAAAI COVID-19 Response Task Force Vaccine Guidance Now Posted

Age Groups That Sustain Transmission: Are We Targeting the Right Population?

  • study published in Science on February 2 estimates that as of October 2020, individuals aged 20-49 are the only age groups sustaining resurgent SARS-CoV-2 transmission with reproduction numbers well above one, and that at least 65 of 100 COVID-19 infections originate from individuals aged 20-49 in the United States. The authors go on to speculate that perhaps vaccines should be focused on this age group earlier rather than later (assuming vaccines reduce transmission).
  • In a similar vein, a modeling study published in Science Advances on February 3 suggests that vaccines that are at least 50% effective in preventing infection could be sufficient to mitigate the pandemic, assuming roughly 70% vaccination coverage. For low vaccine effectiveness, vaccine allocation to high-risk and older age groups would optimally minimize deaths, regardless of coverage. In contrast, vaccines with higher effectiveness would optimally minimize deaths if allocated to high-transmission age groups.
  • As Dr. Fauci stated recently in an interview, if you stop transmission, then less people are infected and the virus has less chance to mutate.

HHS Provider Relief Fund FAQs Update

  • Important modifications relate to: fund allocation (first to unreimbursed expenses, then to losses), allowance for the use of 2020 budgeted revenues for reporting lost revenues with specific requirements, how you still have to report lost revenue even if you use all the funds for expenses, and modifications to the use of funds to support COVID-19 vaccine distribution.

Volunteering at a Vaccine Clinic

  • If you are considering helping out at a vaccine clinic, modifications were recently made to the PREP Act, stating that any healthcare professional who is licensed to prescribe, dispense or administer under the laws of any state, may prescribe, dispense or administer COVID-19 vaccine in any state, even in those in whom the professional is not licensed, although subject to completing the CDC Vaccine Training Modules, and is protected from any suit or liability under State or Federal Law. This also applies to healthcare professionals who are not currently licensed, but held a license in good standing in the last 5 years. Non-practicing healthcare professionals will require documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID–19 vaccine(s) to be administered. Read more details.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


February 1, 2021

Here are today's important updates:

Vaccine News

  • Vaccine DistributionAnnals of Internal Medicine published a video on COVID-19 Vaccine Distribution and Allocation: What Physicians Need to Know.
  • Likelihood of Getting a Vaccine: Read this paper published by JAMA. The Understanding America Study (UAS) is a probability-based internet panel survey of approximately 9,000 noninstitutionalized U.S. adults. Beginning April 1-14 and continuing through November 25–December 8, over 8,000 adults responded to a biweekly survey asking how likely they were to get the vaccine. During November 25–December 8, the self-reported likelihood of getting COVID-19 vaccination was lower among women than men (51% vs 62%; aRR, 0.9 [95% CI, 0.8-0.9]) and Black versus White individuals (38% vs 59%; aRR, 0.7 [95% CI, 0.6-0.8]), and higher among adults aged 65 years and older versus those 18-49 years (69% vs 51%; aRR, 1.4 [95% CI, 1.3-1.5]) and those with at least a bachelor’s degree versus a high school education or less (70% vs 48%; aRR, 1.5 [95% CI, 1.3-1.6]). The surveys indicate an 18% decline in likelihood compared to April.
  • Allergists need to educate their patients about the safety, efficacy and need to receive the vaccine, especially in the underserved population. Top five messages for patients (from the FDA): FDA is publicly sharing information about the vaccines; only safe & effective vaccines tested on tens of thousands of volunteers will be approved; scientists and public health officials, not politicians or their appointees, will decide when a COVID-19 vaccine is safe & effective for public use; by getting the vaccine you protect yourself & family; the vaccine development is moving fast because the medical & scientific community has made it highest priority, not because steps have been skipped.
  • Vaccines and the Variants: In this excellent opinion article, the authors point out several issues related to this problem, including issues with suboptimal immunity limiting the number or increasing the interval between doses, ability of vaccine-induced neutralizing antibodies to attack the virus, the loss of effectiveness of monoclonal antibodies against the variants, and then they propose an approach to the problem.
  • A great video presentation can be found here.
  • Pre-print, not peer-reviewed articles are not usually presented in our messages, but in light of recent press, sera from patients who completed both doses of the Pfizer BioNTech vaccine had similar neutralizing geometric mean titers (GMTs) against SARS-CoV-2 engineered to contain the same mutations as the UK and South African variants, compared to the wild-type, although the GMTs against the South African variant were 19% lower. The authors note that the engineered viruses do not contain the full set of mutations present in the UK and South African variants. Read more.
  • Johnson & Johnson (Janssen) Vaccine: In a press release on January 29 but not published, the company announced preliminary data on their Phase 3 ENSEMBLE vaccine trial. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 single shot vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination. The vaccine candidate was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. The vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination.
  • Novavax: Also announced in a press release, this adjuvated protein subunit vaccine, in preliminary results for Phase 2/3 trials showed up to 89.3% efficacy in the UK cohort and 85.6% efficacy against the UK variant, but results from the South African cohort showed an efficacy of 60% in the HIV-negative population where 93% had the South African variant.
  • Expansion of Vaccination Workforce: HHS issued an amendment to the Public Readiness and Emergency Preparedness Act (PREP Act) on January 28: “All licensed and certified healthcare professionals are now authorized to prescribe, dispense and administer COVID-19 vaccines in any state or U.S. territory after completing the CDC’s COVID-19 vaccine training, regardless of where they are licensed or certified.” The CDC training can be accessed here.
  • Vaccine Safety: According to an update from ACIP, there are now 50 cases of anaphylaxis following administration of the Pfizer BioNTech vaccine, after 10 million doses (5 per million) and 21 cases following administration of the Moderna vaccine (2.8 per million). As some experts have predicted, these rates will likely decline as more doses are administered and will likely not be significantly different from one another. There have now been reports of 196 deaths temporally associated with vaccination, 113 after Pfizer and 83 after Moderna. 66% were residents of long-term care facilities (LTCFs). Estimates of background mortality in LTCFs indicate an expected 11,440 deaths following vaccination. Mortality, then, was actually lower for vaccinated residents. Bottom line: This vaccine is very safe, and severe allergic reactions are very rare.
  • Remember the Second DoseVaxText is a free CDC program that will provide second dose reminders and let recipients know when a dose was missed. To sign up, patients should text ENROLL to 1-833-VaxText (829-8398).
  • Vaccine for Children: From AAP News on Call: Pfizer announced that its vaccine trial in 12-15 year-olds is fully enrolled and it could seek FDA EUA in the first half of 2021. Moderna is currently enrolling children 12-17 in trials.

Smoking and COVID-19 Outcomes

  • If you need another reason to counsel your patients about smoking cessation, JAMA Internal Medicine published a cohort study done at the Cleveland Clinic on patients who were COVID-19 positive and had a complete smoking history.
  • Key findings: The study included 172 current smokers and 910 former smokers. There was a dose response relationship between cumulative pack years of smoking and adverse COVID-19 outcomes. Patients who smoked more than 30 pack-years had 2.25 higher odds for hospitalization, and 1.89 higher odds for dying from COVID-19. This association is likely mediated in part by comorbidities.
  • The study can be found here.

Experience with In-School Learning in Wisconsin

  • As described in an MMWR from January 26, 17 K-12 schools in rural Wisconsin opened this fall and implemented measures to limit spread: masking, physical distancing, cohorts of 11-20 students, and quarantining after exposure.
  • During 13 weeks (August 31- November 29), seven of 4,876 students and zero of 654 staff are known to have gotten COVID-19 at school.
  • No spread is known to have occurred to or from staff in school.
  • >92% of students used masks.
  • The same issue contains a report on spread from a wrestling meet in Florida in December, where a single COVID-19 (+) individual spread the virus to multiple other attendees and teammates with subsequent spread to household contacts. Implications: Indoor sports, where masking and social distancing are not possible, may need to wait until community spread has declined. At the time of this meet, Florida had a community transmission rate of 363/100,000 residents.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


January 25, 2021

Here are today's important updates:

Allergic Reactions to Moderna Vaccine

  • An MMWR report published on January 22 on monitoring of the Vaccine Adverse Event Reporting System (VAERS) from December 21-January 10 detected 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of the Moderna COVID-19 vaccine, which equates to 2.5 cases per million doses. Nine of the 10 cases reported onset of symptoms within 15 minutes, no fatalities. Nine of the 10 cases had a documented history of allergies or allergic reactions, and five of the nine had a previous history of anaphylaxis. Six had a history of allergic reactions to drugs, two to contrast media and one to foods. All 10 were women.
  • Six patients were hospitalized, five in the ICU with four of those requiring intubation.
  • There were also 47 nonanaphylaxis allergic reactions reported.
  • This number is about 1/4 of the rate of anaphylaxis after the Pfizer vaccine (11.1 cases per million doses). Details of the patients with anaphylaxis to the Pfizer vaccine can be found in this JAMA paper published online on January 21.

CDC Updates Vaccine Recommendations

  • Intervals between first and second dose: “The second dose should be administered as close to the recommended interval as possible. However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series.”
  • Interchangeability of vaccine products: “Every effort should be made to determine which vaccine product was received as the first dose, in order to ensure completion of the vaccine series with the same product. In exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series.”
  • Vaccination of persons with a SARS-CoV-2 infection or exposure: Vaccination of persons with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and criteria have been met for them to discontinue isolation. This recommendation applies to persons who develop SARS-CoV-2 infection before receiving any vaccine doses as well as those who develop SARS-CoV-2 infection after the first dose but before receipt of the second dose. While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, may increase with time following initial infection.
  • Vaccinations in persons with a history of dermal filler use: Infrequently, persons who have received dermal fillers may develop swelling at or near the site of filler injection (usually face or lips) following administration of a dose of an mRNA COVID-19 vaccine. This appears to be temporary and can resolve with medical treatment, including corticosteroid therapy. mRNA COVID-19 vaccines may be administered to persons who have received injectable dermal fillers who have no contraindications to vaccination (see ‘contraindications’ section below). No additional precautions are needed. However, these persons should be advised to contact their healthcare provider for evaluation if they develop swelling at or near the site of dermal filler following vaccination.
  • Updated discussion on excipients in the vaccines related to PEG and polysorbate: This can be found in Appendix B at the bottom of the page on the CDC website.

Eosinophils Protective?

  • In a retrospective study published online in JACI: In Practice on January 22, the authors note that asthma patients who presented to the ED with COVID-19 symptoms and positive RT/PCR with an AEC >/= 150 cells/microliter were less likely to require admission for COVID-19, and development of eosinophilia during hospitalization was associated with decreased mortality.
  • The elevated AEC may just be a marker for T2-high asthma and not protective in and of themselves, since treatment with anti-IL5 biologics, which would lower the AEC, are not associated with increased admission or mortality.

Persistent Immunity

  • serological study of 104 patients who survived COVID-19 demonstrated persistence of neutralizing antibodies for at least 6 months, and despite lower amounts over time, these antibodies were still able to neutralize virus in 95% of patients.
  • In a separate serological analysis published in Nature of 87 SARS-CoV-2 recovered patients, neutralizing activity was found to decline by five-fold by 6 months but memory B cells remained largely unchanged. Antibodies expressed by the memory B cells at 6 months had increased potency and resistance to mutations.

Pediatric COVID-19

  • More than 211,000 COVID-19 cases were reported in the United States during the week of January 10-16, the most since the start of the pandemic. The total cases for children and adolescents in the United States is now just over 2.5 million (12.6% of all cases in the United States). Also, 10,182 children (0.8%) have been hospitalized and 191 (0.01%) have died. Read more.
  • An analysis of CDC data on 27,045 children with confirmed COVID-19 showed that African American (OR 2.28) or mixed race (OR 2.95) and an underlying medical condition (OR 3.55) are strong predictors for hospitalization. Death was rare (0.19%) in this population, but increased in children with a pre-existing medical condition (OR 8.88). Underlying medical conditions included asthma, autoimmune disease, cardiovascular disease, chronic lung disease, GI/liver disease, hypertension, immune suppression, metabolic disease, neurologic disease, obesity, and renal disease. Data were not available on the relative risk for specific underlying conditions. The study can be found here.

Food Insecurity Increasing in This Pandemic

  • Data from a predominantly Black cohort living in low-income, racially isolated neighborhoods in Pittsburgh showed an 80% increase in food insecurity as a result of the COVID-19 pandemic, in contrast to a nation-wide increase of 60%.
  • Allergists need to consider this in their food allergic patients.

Rapid Antigen Tests

  • This week’s issue of MMWR reports on the use of the Abbott BinaxNOW rapid antigen test for SARS-CoV-2 infection in 3,419 paired specimens collected from persons 10 years of age and older at two community testing sites in Pima County, Arizona, during November 3–17, 2020. Compared with real-time RT-PCR testing, the BinaxNOW antigen test had a sensitivity of 64.2% for specimens from symptomatic persons and 35.8% for specimens from asymptomatic persons, with near 100% specificity in specimens from both groups.
  • Among specimens positive for viral culture, sensitivity was 92.6% for symptomatic and 78.6% for asymptomatic individuals. When the pre-test probability for receiving positive test results for SARS-CoV-2 is elevated (e.g., in symptomatic persons or in persons with a known COVID-19 exposure), a negative antigen test result should be confirmed by NAAT (nucleic acid amplification test).
  • Rapid antigen tests have shown low sensitivity in asymptomatic patients, but their high specificity and positive predictive value make them useful for testing of patients with a high pre-test probability, allowing for more rapid detection of infectious people for isolation.

So How Many SARS-CoV-2 (+) Patients Are Asymptomatic?

  • Percentages have varied depending on the study, reflecting different populations and different timing, with ranges of 25-40%. Annals of Internal Medicine published a systematic review on January 23, which stated that at least 1/3 of SARS-CoV-2 infections are asymptomatic. Longitudinal studies suggest that nearly 3/4 of persons who receive a positive PCR test who don’t have symptoms will remain asymptomatic.
  • The Asymptomatic novel CORonavirus iNfection (ACORN) study in Indianapolis studied the prevalence of asymptomatic infection in adults over a 6-week period in April and May. Ninety-one of 2,953 people (3.1%) initially presenting as asymptomatic tested (+). In a longitudinal follow-up of 86 of these, 19 (22.1%) developed at least one symptom a median of 6 days after testing (range 1-29 days).

Evidence for Pandemic Fatigue

  • An analysis of survey responses from 16 waves of the Coronavirus Tracking Survey (CTS) completed between April 1 and November 24 showed that adherence to most nonpharmaceutical interventions (NPIs) declined over that time period. The national NPI adherence index decreased from 70.0 in early April to the high 50s in June and increased again to 60.1 in November. The NPI adherence index declined in all regions, but was significantly greater in the Midwest. Of all the recommended NPIs, the only one to increase was mask wearing.

Vaccines: Immunology and the Pipeline

  • As we anticipate the arrival of additional vaccines for SARS-CoV-2, perhaps it is time to revisit this review on viral immunology and vaccines published this past October in Lancet and also this new article from Scientific American on novel vaccine approaches being studied now.

Billing and Administration Codes for Vaccines

  • Pfizer: billing: 91300, administration: 0001A (first dose), 0002A (second dose)
  • Moderna: billing: 91301, administration: 0011A (first dose), 0012A (second dose)
  • Astra-Zeneca: billing: 91302, administration: 0021A (first dose), 0022A (second dose)
  • Janssen (Johnson & Johnson): billing: 91303, administration: 0031A (single dose)

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


January 18, 2021

Here are today's important updates:

Ad26.COV2.S COVID-19 Vaccine

  • Interim results from the phase 1-2a trial of the Johnson & Johnson vaccine were reported in the NEJM on January 13. This vaccine is a recombinant, replication-incompetent adenovirus 26 vector encoding a full length and stabilized SARS-CoV-2 spike protein. Results from two of three cohorts (18 to 55-year-olds and >/=65-year-olds) were reported. This trial examined the effects of single versus double dose, and low dose versus high dose.
  • Neutralizing antibody titers were detected in 90% or more of all participants on day 29 after the first vaccine dose and reached 100% by day 57 in 18 to 55-year-olds with a further increase in titers, regardless of vaccine dose or age group. Titers remained stable until at least day 71 in the 18 to 55-year olds, the latest time period in this studyA second dose provided an increase in titer by a factor of 2.6-2.9Spike antibody titers were similarOn day 14, CD4+ T-cell responses were detected in 76 to 83% of the younger cohort, and 60 to 67% of the older cohortCD8+ T cell responses followed a similar pattern.
  • Adverse reactions were similar to current vaccines, and occurred in 65 to 85% of recipients. The most common were fatigue, headache and myalgia.
  • Further analysis of one versus two dose schedules, along with efficacy, are being assessed now in a phase 3 trial.

SARS-CoV-2 Variant

  • As of January 13, the SARS-CoV-2 B1.1.7 variant, which has been associated with increased transmissibility in Europe, has been identified in 76 cases across 10 states in the United States. Currently there is no known difference in clinical outcomes associated with the variant. Read more here.

Transmission of SARS-CoV-2 Low in Schools That Take Precautions

  • In this pre-print release of an article to be published in Pediatrics, researchers from Duke University and the University of North Carolina found that schools that employed mitigation strategies had a very low incidence of in-school transmission of SARS-CoV-2 in the first 9 weeks of this past fall. The effect of very high community transmission such as we are seeing now remains to be seen.
  • In a related study, the MMWR from January 13 reviewed data on testing results in large groups of patients in age categories comparable to school age differences. They noted similar trends in positive tests and percent positive compared to adults, and noted that rates were lowest in the age group 0-4 with an increase in each successive age group. Hospitalizations and ICU admissions were highest in the 0-4 age group, but all age groups 0-17 weekly incidence was lower than adults (>25) but the 18 to 24-year-old group was higher than adults for the entire study period. “Lower incidence among younger children and evidence from available studies (2–8) suggest that the risk for COVID-19 introduction and transmission among children associated with reopening child care centers and elementary schools might be lower than that for reopening high schools and institutions of higher education... CDC recommends that K–12 schools be the last settings to close after all other mitigation measures have been employed and the first to reopen when they can do so safely."
  • All this information may not be applicable if the more transmissible SARS-CoV-2 virus becomes widespread in the United States. A recent New York Times article may be reassuring. They cite recent research from Public Health England, based on detailed contract-tracing of about 20,000 people, including 3,000 children <10, showing young children were about half as likely as adults to transmit the virus to others.

Lockdowns Work

  • In this study published January 13 in the Journal of General Internal Medicine, the authors used WHO data from nine different countries (including the United States) and conducted a cross-country comparative evaluation using a susceptible-infected-recovered (SIR)-based model completed with pharmacokinetic approaches. In those countries that had an early lockdown period followed by a gradual deconfinement, it resulted in a rapid decline in infections and a reduced R0The countries that had no or inconsistent lockdowns followed by rapid deconfinement had a prolonged plateau of infections and an elevated R0 was noted during the study period from February 23 to June 14.

Saliva Versus NP Swab

  • systematic review and meta-analysis of 16 studies compared the salivary nucleic acid amplification test (NAAT) to an NP swab collection. The pooled sensitivity of the saliva NAAT was 83% compared to 85% for the NP swab NAAT, and both tests had a specificity of 99%. Limitations of the study: Eight peer-reviewed studies and eight pre-prints were included in the meta-analysis (5,922 unique patients). There was significant variability in patient selection, study design, and stage of illness at which patients were enrolled. Fifteen studies included ambulatory patients, and nine exclusively enrolled from an outpatient population with mild or no symptoms. Larger trials are needed to confirm this data, but it is good to see that the sensitivity was comparable in those with low-to-no symptoms, which is where many of the tests fail.

New HHS Provider Relief Fund FAQ Update

  • HHS has not yet made an announcement related to Phase 4 funding and the website still notes that the Reporting Portal is slated to be available as of Friday, January 15.
  • The latest questions modified or added relate to providers who purchased a TIN, an extension to submission date for audits, guidance for CPAs on audits, methodology for provider payment in Phase 3, and when Phase 3 payments will be made (through the first months of 2021).
  • Certain applicants may not receive these full amounts (88% of their reported losses) because HHS determined the revenues and operating expenses from patient care reported on their applications included figures that were not exclusively from patient care (as defined in the instructions), reported figures were not reflected in submitted financial documentation, or reported figures were extreme outliers in comparison to other applicants of the same provider type; instead, HHS capped the amount paid to these provider types based on industry estimates of revenue and operating expenses from patient care.

No, It's Not Just Another Flu!

  • Most people get it now, but you may still encounter patients who feel that COVID-19 is just another flu. This article may provide you some evidence for comparison in hospitalizations and mortality between the two diseases.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


January 12, 2021

Here are today's important updates:

Vaccine Reactions (Now What?)

  • The CDC has updated its guidance on the administration of the SARS-CoV-2 mRNA vaccines with respect to pre-vaccine risks and post-vaccine reactions. Contraindications to either of the mRNA vaccines now include immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components, including polyethylene glycol (PEG). The CDC goes on to state: These persons should not receive mRNA COVID-19 vaccination at this time unless they have been evaluated by an allergist/immunologist and it is determined that the person can safely receive the vaccine (e.g., under observation, in a setting with advanced medical care available). But then the CDC says: Persons with an immediate allergic reaction to the first dose of an mRNA vaccine should not receive additional doses of either of the mRNA COVID-19 vaccines.
  • Drs. Mariana Castells and Elizabeth Phillips have also written an article titled "Maintaining Safety with SARS-CoV-2 Vaccines" that was published in NEJM on December 30. It is worth reading for allergists who may encounter patients with reactions or potential reactions to the vaccines.
  • summary of allergic reactions following the Pfizer vaccine between December 14 and 23 was published in MMWR on January 6. There have been 104 cases of allergic reactions with 21 cases of anaphylaxis after administration of 1,893,360 first doses (11.1 cases per million), about 10 times the rate of anaphylaxis after the flu vaccine (1.3 cases per million). Seventeen of these cases occurred in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. Symptom onset after the vaccine was a median of 13 minutes (2-150 minutes), 71% onset within 15 minutes. Non-anaphylaxis symptoms included pruritis, rash, itchy and scratchy throat and mild respiratory symptoms. Case details are listed in the article.

Stick With Recommended Vaccine Dose Intervals

Delayed Face or Lip Swelling After Moderna Vaccine

  • There were three cases of lip or facial swelling that occurred 1-2 days after vaccination in the clinical trials, that are felt to be due to an inflammatory reaction occurring in dermal filler placement. These are not IgE-mediated reactions and can be treated with oral corticosteroids and are not contraindications for receipt of vaccines, according to the American Society for Dermatologic Surgery Guidance.

New Vaccine Resources

  • Hart Health Strategies, the AAAAI’s legislative and government consultants, have developed a handy PDF loaded with information and links about the COVID vaccines. A link to the PDF is posted on the AAAAI COVID-19 resources page. This PDF will be a “living” document and can also be accessed via this link.
  • The AAAAI has developed a patient article about vaccine safety and indications that is available in English and Spanish. Both versions of the article can also be found within the Patient Information section of the AAAAI COVID-19 resources page.

Transmission From Symptomatic Versus Asymptomatic COVID-19 Subjects

  • A modeling study published in JAMA Network Open on January 7 reports that 59% of all transmission came from asymptomatic transmission, with 35% from presymptomatic and 24% from asymptomatic patients.
  • On the other hand, an article published in Lancet on December 18 suggested that transmission from symptomatic patients was 3.85 times higher than asymptomatic (close contacts).

More on Herd Immunity and Vaccine Dosing

  • There has been extensive discussions on herd immunity in the lay and scientific press. This article in the American Journal of Clinical Pathology written by the Medical Director of the Immunopathology Lab at the Cleveland Clinic offers an interesting overview of herd immunity and the importance of vaccinating a large percentage of the population, and continued precautions such as mask wearing, physical distancing and handwashing.

Monoclonal Antibody Effect in COVID-19 Outpatients

  • In this NEJM article, Regeneron’s monoclonal antibody cocktail was noted to reduce viral load in outpatients with COVID-19. The effect was greatest in those with negative initial antibody titers and those with the highest initial viral load.

High-Titer Plasma Therapy May Be Effective If Given Early to Older Adults 

  • An article in NEJM that was published online January 6 reported the results of a trial of high-titer plasma therapy in 160 older adults (75 years of age and older) with mild disease, within 72 hours of onset of the disease. The relative risk reduction was 48% for the development of severe respiratory disease.

Latest Data Suggest Long-Term Immunity After Infection

  • In an article in Science, it was noted that B-cell and T-cell immunity were still robust 6 months or more after infection, although each immune component had different kinetics.

FDA Issues Alert for False Negative Results With Curative SARS-CoV-2 Test (RT/PCR)

  • In this alert, the FDA stresses the importance of performing the test in accordance with its authorization, that it is indicated only for symptomatic individuals within 14 days of symptom onset, samples must be collected by or under the direct supervision of a trained healthcare worker, and a negative result does not rule out COVID-19. Consider retesting with a different test if you suspect an inaccurate result. Find more details here.
  • In the MMWR from January 1, use of the Sofia antigen test to screen college students had an 80% sensitivity and 98.9% specificity in symptomatic students, but the sensitivity was only 41.2% in asymptomatic students.
  • On January 8, the FDA also issued an alert related to concerns over the effect of viral mutations on testing. Currently the impact is expected to be low, but this is going to be carefully followed.

HHS Renews Determination of a Public Health Emergency (PHE)

  • On January 7, HHS Secretary Azar renewed the determination of a PHE for another 90 days, thus extending the waivers and flexibilities granted for the earlier PHE.

AAP Updates Guidelines for Safe Schools 

ACIP Updates Allocation Recommendations

  • Read this MMWR.
  • It remains up to individual states, and sometimes individual counties, to determine the actual allocation guidelines for the SARS-CoV-2 vaccines.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


January 4, 2021

Here are today's important updates:

Factors Associated With Positive SARS-CoV-2 Test Results in Children and Adolescents

  • A study in Mississippi covering the time period from September through November found that among children and adolescents aged <18 years in Mississippi, close contact with persons with COVID-19 and gatherings with persons outside the household and lack of consistent mask use in school were associated with SARS-CoV-2 infection, whereas attending school or child care was not associated with receiving positive SARS-CoV-2 test results.

Reasons Behind Mask Wearing

  • In this narrative review titled "Masks and Face Coverings for the Lay Public" published in Annals of Internal Medicine on December 29, the authors do a good job of covering the latest findings on the dynamics of SARS-CoV-2 transmissions and the science behind masks as source control and personal protection.

Medicare FFS Claims: 2% Payment Adjustment (Sequestration) Suspended Through March

  • The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended the payment adjustment percentage of 2% applied to all Medicare Fee-For-Service (FFS) claims from May 1 through December 31. The Consolidated Appropriations Act, 2021, signed into law on December 27, extends the suspension period to March 31, 2021.

Latest Relief Funding Act Includes More Money for PPP

  • The bill includes $284 billion in funding for the Paycheck Protection Program (PPP).

Allergists Need to Encourage Vaccination

  • In a research letter published in JAMA on December 29 titled "National Trends in the US Public’s Likelihood of Getting a COVID-19 Vaccine—April 1 to December 8, 2020", the authors present the results of a nationally representative internet-based survey of U.S. adults that asked about the likelihood of an individual to get one of the vaccines. The results indicated that 74% of participants would be likely to get the vaccine in April, declining to 56% in early December. This decline was seen for both women and men and in all age, racial/ethnic and educational groups.

COVID-19 Risks in HIV

  • In a small international study published in HIV Medicine, a current CD4 T-cell count of <350 cells/microliter was independently associated with a 2.85-fold risk for severe COVID-19. A lower nadir CD4 T-cell count of <200 cells/microliter was associated with mortality.

HHS PRF Update

  • Most notably, HHS has clarified the funding methodology for the Phase 3 funding. What is the payment amount that an applicant should expect to receive from Phase 3 of the General Distribution? (Modified 12/28/2020) If an applicant has not yet received and kept a payment that is approximately 2% of annual revenue from patient care as part of either Phase 1 or 2 of the General Distribution, then they will receive at least that amount in Phase 3 payment. In addition to this amount, providers will be paid up to 88 percent of their reported losses and net change in their operating expenses from patient care from the first half of 2020. Some applicants will not receive an additional payment either because they experienced no change in revenues or net expenses attributable to COVID-19, or because they have already received funds that equal or exceed reimbursement of 88 percent of reported losses.
  • HHS has begun issuing payments in mid-December and will continue making payments through the first months of 2021.

COVID-19 Toll

  • According to figures from the Kaiser Health Foundation and the Guardian, over 2,900 healthcare workers have died from COVID-19, which is a much higher figure than what has been released by the federal government.
  • One million more children have been infected since mid-November, pushing the total children infected to over two million.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


December 24, 2020

Here are today's important updates:

Key Items in the Latest COVID-19 Relief Bill If Signed by the President 

  • Continued coverage of the temporary transitional home infusion therapy services for Medicare patients on biologics and IVIG/SCIG.
  • Labor/HHS Explanatory Statement encourages the NHLBI to develop a multidisciplinary project to examine inflammation in children with uncontrolled asthma.
  • The Medicare IVIG demonstration project has been extended through December 2023.
  • $22.4 billion for testing and contact tracing, with no less than $2.5 billion for high risk and underserved populations and $790 million for IHS to support tribes.
  • $19 billion dedicated for the nation’s supply of COVID-19 vaccines and therapeutics.
  • $8.75 billion for vaccine distribution, administration, planning, etc.
  • $3.25 billion for the Strategic National Stockpile.
  • Authorizes a national campaign for vaccine safety and effectiveness.
  • Expands, enhances and improves public health data systems at CDC.
  • Provider Relief Fund (PRF) impacts: $3 billion in new resources, additional flexibilities.
  • Provides for a three month delay of the Medicare sequester payment reductions through March 31, 2021.
  • Provides a one-time, 1 year increase in the Medicare Physician Fee Schedule of 3.75% (but puts a 3 year hold on the complex care add-on code).
  • Adds 1,000 new Medicare funded GME FTE residency positions, beginning in FY 2023 under certain circumstances.
  • Allows PAs to bill Medicare directly.
  • Protects against surprise medical bills by ensuring that the patient does not have to pay any more than the in-network cost sharing and provides for an independent resolution process for providers.
  • Requires Medicare Part D plans to use a “real time benefit tool” to inform providers how much a patient will have to pay for a drug, at the time of prescribing.

NIH Developing Study of Allergic Reactions to the Pfizer Vaccine

  • In a Washington Post article dated December 21, the NIH is “rushing” to develop a study protocol for people who have had anaphylactic reactions to the Pfizer vaccine. Daniel Rotrosen, MD, Director of the Division of Allergy, Immunology and Transplantation at the NIAID, will head up the study. Plans are to recruit volunteers who have had a history of severe allergic reactions who will receive the vaccine under close supervision. They considered enrolling volunteers with a history of allergy to PEG, but this condition is so rare, that they would not likely be able to recruit enough individuals. The group has been meeting with representatives from the FDA, Pfizer and Moderna, as well as scientists and researchers (including members of the AAAAI) with knowledge of allergic reactions to vaccines and vaccine components.
  • There have been 6 cases of anaphylaxis to the Pfizer vaccine out of 556,000 doses which are being evaluated.

NIH to Support Radical Approaches to Nationwide COVID-19 Testing and Surveillance

  • A variety of interesting approaches are being funded, some of which can be found here.

Long-Term Follow-up of COVID-19 Patients

  • A previous message reviewed information on the long-term outcomes in hospitalized patients with COVID-19. Here are two studies looking at the two extremes: non-hospitalized patients and ventilated patients.
  • In a study of 451 non-hospitalized COVID-19 patients in Norway, 53% of women and 67% of men were symptom-free at 1.5 to 6 months after the diagnosis, while 16% reported dyspnea, 12% loss/disturbance of smell, and 10% loss/disturbance of taste. In multivariable analysis, having persistent symptoms was associated with the number of comorbidities and number of symptoms during the acute COVID-19 phase. Median age of the participants was about 45 years.
  • A group from the Netherlands reported 3 month follow-up data on 94 patients who were mechanically ventilatedOnly 55% were still alive after 3 monthsOf those, 43 out of 48 had pulmonary function abnormalities, all restriction, and 47 out of 48 had abnormal CT scans. Half of the patients had an abnormal 6-MWT.

NIH Researchers Isolate Promising Mini Antibodies Against COVID-19

  • As described here, these are “nanobodies” which were produced by sensitizing a llama against COVID-19. Such tiny antibodies are naturally produced by camelids. Nanobodies isolated in the lab are essentially free-floating versions of the tips of the arms of the heavy chain proteins. They are more stable, less expensive to produce than typical antibodies and at least one of these appears to attach to the spike protein with greater affinity than other antibodies. These nanobodies are effective in an inhaled form as well.

Herd Immunity

  • recent study using modeled data from Japan, Italy, France and Switzerland that included asymptomatic infection suggests herd immunity could be achieved when active symptomatic patients are 10 to 25% of the population. The only problem is that would mean a total of 80 million cases in the United States and 1.6 million deaths.

Secondary Attack Rates in Households: The New Hot Spots

  • To quote the abstract from the article, which was published in JAMA Network Open on December 14: “In this meta-analysis of 54 studies with 77,758 participants, the estimated overall household secondary attack rate was 16.6%, higher than observed secondary attack rates for SARS-CoV and Middle East respiratory syndrome coronavirus. Controlling for differences across studies, secondary attack rates were higher in households from symptomatic index cases than asymptomatic index cases, to adult contacts than to child contacts, to spouses than to other family contacts, and in households with 1 contact than households with 3 or more contacts. These findings suggest that households are and will continue to be important venues for transmission, even in areas where community transmission is reduced.”

HHS Has Again Updated the PRF FAQs

  • New questions relate to receipt of form 1099’s and tax implications of the PRF.

Combat COVID Website

  • HHS in coordination with NIH and Operation Warp Speed has just launched a new website entitled Combat COVID to pull together the most current information for people of all groups, races, ethnicities and backgrounds who want to get involved in fighting the pandemic. You can find resources to join a prevention trial, locate treatment trials if you are infected, find places to donate plasma if you have recovered from an infection, or find treatment options or trials if you are a physician.

Another Home Test, Now Without a Prescription

  • FDA granted an EUA on December 15 for a SARS-CoV-2 antigen test—that was developed with support from the NIH RADx Initiative—from Ellume USA LLC (Valencia, CA) designed for use at home without a prescription. The test uses a self-collected mid-turbinate nasal swab, which is inserted into a single use cartridge with results in 15 minutes. The at-home analyzer connects to the user’s smart phone via Bluetooth and pairs with a downloadable app that provides step-by-step instructions and displays results. According to the approval letter, the sample can be self-collected by anyone 16 years of age or older, or by an adult for anyone 2 years of age or older. Sensitivity and specificity of the test is not listed on the FDA site. Allergists need to counsel their patients about the appropriate timing for the test, and that both negative and positive results may need to be confirmed with RT/PCR. Additional information can be found here.

NIOSH and ASTM International Writing Guidelines for Mask Ratings

  • In guidelines that may be released next month, these groups are working to develop minimum filter efficiency standards and labels.
  • The article can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


December 21, 2020

Here are today's important updates:

CDC's ACIP Expands on Precautions and Contraindications for Pfizer Vaccine

  • "Severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 vaccine is a contraindication to vaccination listed in the prescribing information. Anaphylactic reactions in persons outside of clinical trials have been reported. While these reports are further investigated, CDC considers a history of severe allergic reaction (e.g., anaphylaxis) to any other vaccine or injectable therapy (e.g., intramuscular, intravenous, or subcutaneous) as a precaution but not a contraindication to vaccination. In persons who report a history of anaphylaxis to another vaccine (i.e., any other vaccine besides the Pfizer-BioNTech COVID-19 vaccine) or injectable therapy, a risk assessment should be conducted to determine type of reaction and certainty of information. For example, whether the medication was administered by injection or another route or whether the reaction constituted a severe allergic reaction (e.g., required use of epinephrine [EpiPen®, etc.], resulted in hospitalization). These persons may still receive vaccination, but they should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefits of vaccination. A history of mild allergic reaction to a vaccine or injectable therapy, such as urticaria alone without signs or symptoms of anaphylaxis, is not a contraindication or precaution to Pfizer-BioNTech COVID-19 vaccination. In addition, allergic reactions (including severe allergic reactions) not related to vaccines or injectable therapies (e.g., food, pet, venom, environmental, or latex allergies; oral medications [including the oral equivalents of injectable medications]) are not a contraindication or precaution to vaccination with Pfizer-BioNTech COVID-19 vaccine.”
  • Additional discussion about clinical considerations for use of the vaccine can be found here.
  • Allergists need to know that the CDC/ACIP/FDA and NIAID are aware of the reactions that have occurred and are actively working, along with leadership of the AAAAI, to determine the cause for these reactions, and developing protocols to help you deal with them.
  • The CDC has also issued guidelines on precautions and management of anaphylaxis to sites that administer the vaccines.
  • Recommendations are to avoid any other vaccinations for 14 days before or after the SARS-CoV-2 vaccine, but if you have had another vaccine within that 14 day window, don’t wait to get this vaccine.
  • Recommendations are to defer vaccination for 90 days after receiving convalescent plasma or monoclonal antibody treatment for COVID-19.

Moderna Vaccine

  • This vaccine has been granted an EUA and approval from the CDC/ACIP.
  • Results from the clinical trials are very similar in efficacy and safety compared to the Pfizer vaccine. The FDA Briefing Document can be found here. This document presents both interim analysis using a data cutoff of November 7, with a median follow-up of 7 weeks post-dose one, and the final scheduled analysis from a data cutoff of November 21, with a median follow-up >2 months post-dose two. This summary covers the final scheduled analysis.
  • Efficacy: Vaccine efficacy was 94.1% (95% CI 89.3%, 96.8%) with 11 cases of COVID-19 in the vaccine group and 185 cases in the placebo group. Unlike the interim data, the vaccine efficacy when stratified by age group was 95.6% (95% CI 90.6%, 97.9%) for participants 18 to <65 years of age and 86.4% (95% CI 61.4%, 95.5%) for participants 65 years of age or older. Other than the age group difference, there were no vaccine efficacy differences based on race, ethnicity, gender or medical comorbidities associated with high risk for severe COVID-19. Vaccine efficacy against severe COVID-19: 30 cases in the placebo group, 0 in the vaccine group. Vaccine efficacy after the first dose was 80.2% (95% CI, 55.2%, 92.5%) in the 2,000+ patients who only received one dose, but these patients were only followed for 28 days.
  • Safety: The most common adverse reactions: injection site pain (91.6%), fatigue (68.5%), muscle pain (59.6%), joint pain (44.8%), chills (43.4%), fever (14.8%). Most of these were mild to moderate, began on day 1-2 and lasted 2 days. A small number of participants reported systemic reactions longer than 7 days, but there was no difference between vaccinated and placebo groups. Lymphadenopathy (axillary) was reported in 21.4% of vaccine recipients <65 years of age, and 12.4% in those >65 years of age, compared to 7.5% and 5.8% in placebo in those age groups respectively. Severe adverse reactions occurred in 0.2% to 9.7% of participants, and were more frequent after the second dose and less common in those 65 years of age and older. Hypersensitivity adverse events were slightly greater in the vaccine group (1.5%) compared to the placebo group (1.1%). There were no anaphylactic or severe hypersensitivity reactions. This vaccine also contains PEG in the lipid capsule. Serious adverse events were low (1.0%) without meaningful imbalances between study arms. Other than the differences in the age groups and reactogenic reactions, there were no safety differences with respect to race, ethnicity, gender or pre-existing conditions.
  • *Efficacy against asymptomatic infection: preliminary data only, NP swabs were collected pre-dose one and pre-dose two. Number of positive swabs pre-dose two in negative baseline participants was 14 in the vaccine group and 38 in the placebo group, suggesting that some asymptomatic infections may be prevented with just the first dose.

And the Disinformation Shifts to SARS-CoV-2 Vaccines

HHS Announces Increase in Provider Relief Funds

  • After review of Phase 3 applications, the Health Resources and Services Administration announced on December 16 that it would be distributing $24.5 billion to over 70,000 providers, up from the initial $20 billion. The $4.5 billion increase will allow reimbursement for up to 88% of reported losses. Over 35,000 applicants will not receive additional funding because they either had no losses or payments to date already equaled or exceeded the 88% threshold. Payments were to begin on December 16 and continue through January.
  • A state-by-state breakdown on the first batch of Phase 3 payments can be found here. The data will be updated through January as payments are completed.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


December 15, 2020

Here are today's important updates:

Additional Vaccine Information

  • Here is the Contraindications and Precautions section of the Pfizer-BioNTech vaccine PI:
    • Severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer BioNTech COVID-19 vaccine is a contraindication to vaccination.
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
    • Because of reports of anaphylactic reactions following vaccination outside of clinical trials, the additional following guidance is proposed: A severe allergic reaction to any vaccine or injectable therapy (IM, IV or SC) is a precaution to vaccination at this time; vaccine providers should observe patients after vaccination to monitor for the occurrence of immediate allergic reactions: persons with a history of anaphylaxis (not due to vaccines or injectable medications) 30 minutes, all other persons 15 minutes.
    • What does “precaution” mean: discussion with provider on risk assessment (evaluation of previous reaction), potential deferral of vaccination, 30 minute observation if vaccinated.
  • Here is a nice discussion of the data behind the ACIP decision to approve the Pfizer-BioNTech SARS-CoV-2 vaccine.
  • As far as monitoring for adverse reactions, there are four separate safety monitoring systems available for this vaccine: VAERS (adverse events requiring reporting listed under the EUA); V-Safe (a text- and web-based cell phone system requiring voluntary patient registration that should be encouraged by vaccine providers); VSD (Vaccine Safety Datalink, which is a passive system for patients enrolled in large healthcare systems); and CISA (Clinical Immunization Safety Assessment) Project. You can read more here.
  • ACOG and ACIP recommend that vaccination should not be withheld from pregnant or lactating women, but they should be informed that there are insufficient data on safety at this time.
  • The AAAAI COVID-19 resources page also has a new COVID-19 Vaccines, Monoclonal Antibodies and Other Treatments section that will be regularly updated. 

Coding for Vaccines

  • Pfizer vaccine: 91300 for vaccine, 0001A for administration (first dose) ($16.94), 0002A (second dose) ($28.39)
  • Moderna vaccine: 91301 for vaccine, 0011A and 0012A for first and second dose administration, respectively. Same reimbursement.
  • No payment allowance for vaccine at this time, since MD will receive at no cost.

Other COVID-19 Codes

  • Contact with and (suspected) exposure to COVID-19: Z20.822
  • Personal history of COVID-19: Z86.16
  • Multisystem inflammatory syndrome: M35.81

CDC Suggestions for Adverse Reactions in Healthcare Workers

  • Vaccine-related symptoms include fever, chills, myalgias, fatigue and headache. They typically start 1-3 days after vaccination and last 1-2 days. They DO NOT INCLUDE cough, shortness of breath, sore throat, rhinorrhea, loss of smell or taste.
  • If the healthcare worker has only vaccine-related symptoms with a consistent time course and has not been exposed to a known or probable case of COVID-19 in the previous 14 days, they do not need to be evaluated for other causes and can return to work when afebrile and feeling better.
  • If the time course is not consistent (e.g., fever lasting longer than 2 days) or additional symptoms are present, or they have had unprotected contact with a COVID-19 patient in the previous 14 days, they should be evaluated for other causes of the symptoms.

Treatment

  • Details on the EUA for bamlanivumab, Eli Lilly’s IgG1 neutralizing monoclonal antibody can be found here. This drug is indicated for patients 12 years of age or older with mild-moderate COVID-19 and high risk for severe disease. Overall markers for high risk: BMI greater or equal to 35, chronic kidney disease, DM, immunosuppression, being 65 years of age and older; in patients 55 years and older: cardiovascular disease, hypertension, COPD or other chronic respiratory disease; and in 12 to 17-year olds: sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorders, a medical-related technological dependence (e.g., tracheostomy, gastrostomy) and asthma or other chronic respiratory disease that requires daily treatment. The drug is not authorized for use in patients who are hospitalized or require oxygen therapy because of COVID-19.

HHS Updates PRF FAQs Again

  • New or modified questions were posted on December 4. These relate to eligibility, provider overpayment and return of funds, eligible expenses, audit support and extensions, and reporting requirements.

Clarification on MIPS Exceptions

  • The deadline for hardship exceptions for MIPS reporting was extended to February 1, 2021, with one exception. If you are ONLY applying for a hardship exception to the interoperability measure, then that deadline remains December 31, 2020.

Clinical Status and Lung Function 10 Weeks After Severe Infection

  • An article in Respiratory Medicine that was published on November 29 evaluated 220 patients at a median of 10 weeks after discharge and noted that 54% had abnormal PFTs, mostly restriction. Lung function findings did not correlate with imaging results or symptoms, but did with hospital LOS, ICU and mechanical ventilation.

At-Home Testing

  • FDA has issued an EUA for the Lucira COVID-19 All-In-One Test Kit, the first COVID-19 diagnostic test for self-testing at home and that provides rapid results in individuals 14 years of age and older. This can also be used as a POC test for provider offices for all ages, but in offices the FDA requires that samples be collected by a healthcare provider for children less than 14 years of age. A patient, on advice of their healthcare provider, uses a self-collected swab that can be read directly from the test unit after 30 minutes.
  • In another study that may pave the way for more at-home testing, saliva sampling and oral rinses were found to be very comparable to NP and throat swabs in sensitivity for diagnosis.

Face Masks and Breathing

  • There continue to be myths and disinformation spread about the “risks” of face masks. Much of the published material to date has been limited to small groups of patients. In a review article published by Annals of the American Thoracic Society on November 16, the authors point out that there is a substantial body of literature on this question. Their review indicates little if any effect on work of breathing or other parameters during physical activity.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


December 11, 2020

Here are today's important updates:

Vaccine News

The FDA Briefing Document for the Vaccine and Related Biological Products Committee (VRBAC) meeting on December 10 concerning the Pfizer-BioNTech vaccine is available here and it has also been posted on the AAAAI COVID-19 resources page

Efficacy Summary: For participants without evidence of prior COVID-19, vaccine efficacy (VE) occurring at least 7 days after dose 2 was 95.0% (8 cases in the vaccine group and 162 in the placebo group). VE in patients with and without previous COVID-19 was 94.6% (9 and 169 cases respectively). Only 3% of participants had evidence of prior COVID-19 at the time of enrollment. The 95% credible interval for the vaccine efficacy was 90.3% to 97.6%. VE in patients >55 years of age was 93.8%. These results were consistent across gender, race and ethnicity. VE was also similar for those with co-morbidities, but the CI was wide due to small numbers of patients in any given category other than obesity or hypertension. Only one vaccine participant had severe disease, and that did not require hospitalization. Only 9 patients in the placebo group had severe disease, however. VE after dose 1 was 52.4% (75% for severe disease).

Safety Summary: The most common adverse systemic reactions were injection site reactions (84.7%), fatigue (62.8%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Most reactions were mild to moderate. The rate of severe adverse reactions was 0.0% to 4.6%, and were more frequent after dose 2 and less frequent in adults >55 years of age. Lymphadenopathy was reported in 0.3%. Bell’s Palsy occurred in 4 vaccine participants, but this is not greater than the expected background rate. Systemic adverse events generally occurred on the day after the dose and lasted 1-2 days.

Vaccine Reactions in the UK: Reports of two episodes of anaphylaxis and another of an allergic reaction have prompted Britain’s Medicine and Health Care Products Regulatory Agency (MHRA) to recommend that anyone with a history of anaphylaxis to a vaccine, food or drug not receive the vaccineHere is the British Society of Allergy & Clinical Immunology's statement concerning this recommendation. We do not have details on the reactions or the patients that reacted other than the two patients who had an anaphylactic reaction had a previous history of anaphylaxis. This topic was discussed at the AAAAI Board of Directors level on December 9 and the AAAAI Board and COVID-19 Response Task Force posted a statement on the VRBAC comment site for the FDA hearing on December 10 and will be following the development closely. If and when the FDA grants an EUA to the Pfizer vaccine, they will also list their recommendations about who should and should not receive the vaccine. The AAAAI will comment at that time.

Helpful References Concerning Anaphylaxis After Vaccination: JACI 2016; 137(3):868-78 and JACI 2019; 143:1465-73. Bottom line: anaphylaxis after vaccination is rare, and can occur in patients with no prior history of sensitization.

The Advisory Committee on Immunization Practices (ACIP) will meet today, December 11, from 12:00 to 5:00 pm EST and December 13 from 12:00 to 4:00 pm EST to discuss final recommendations on vaccine priorities. These hearings will be streamed live on the web here.

The CDC will host a COCA Call on COVID-19 Vaccine Safety on December 14 from 1:00 to 2:00 pm EST. Here is the Zoom link and the Webinar ID is: 161 126 4903

CMS Extends Deadline for MIPS Extreme and Uncontrollable Circumstances to February 1, 2021 

The previous deadline was December 31, 2020.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


December 7, 2020

Here are today's important updates:

Errata

  • Our last message stated that there were 100 million healthcare workers in the U.S., based on erroneous information from a source. According to the CDC there are 18 million healthcare workers, but according to the U.S. Census in 2018 there were 20.5 million people who self-identified as working in the healthcare field. There are also an additional three million nursing home residents and staff, so 48 million doses of vaccine will be required just to immunize the recommended initial groups.

CDC Revises Quarantine And Masking Guidelines

  • The CDC announced Options to Reduce Quarantine for Contacts of Persons with SARS-CoV-2 Infection Using Symptom Monitoring and Diagnostic Testing.
  • The CDC still recommends a quarantine period of 14 days, however, based on local circumstances and resources, the following options to shorten quarantine are acceptable alternatives.
  • Quarantine can end after day 10 without testing if there are no symptoms during daily monitoring (residual transmission risk estimates 1-10%).
  • When diagnostic testing resources are sufficient and available, then quarantine can end after day seven with individual testing negative within 48 hours before the time of planned quarantine discontinuation (residual transmission risk estimates 5-12%).
  • Continued symptom monitoring and masking must be done through day 14.
  • Background for the change and additional details can be found here.
  • On 12/4, the CDC announced new recommendations for universal mask wearing indoors except in your own home (unless non-household members are visiting).
  • A nice summary of Guidance for Public Health Strategies, with the rationale behind it, can be found here.

COVID-19 Is Not Always Mild In Younger People

  • From March-August 2020, data from the COVID-NET indicated that more than one in five younger adults (ages 18-49) without underlying conditions who were hospitalized with COVID-19 in the U.S. experienced severe illness requiring ICU-level care.

Vaccines

  • ACIP recommendations for vaccine allocation can be read here. These are interim recommendations for the initial vaccine distributionKey Message: health care workers and nursing home residents are at the top of the priority list. Expect states to approach the “health care workers” differently, depending on their vaccine allocation. They may subdivide HCWs into different risk categories for vaccination.
  • Studies of the current vaccine candidates have been focused on whether they protect a recipient from getting sick from the virus, but they haven’t looked at whether a vaccine recipient can still carry and transmit the virus. This is another reason why we should encourage our patients to get the vaccine and to continue other mitigation strategies. A good discussion on this issue can be found here.
  • Peer-reviewed publications: for the AstraZeneca/Oxford vaccine, Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial, and for the Moderna/NIAID vaccine Durability of Response after SARS-CoV-2 mRNA-12373 Vaccination. Key Message from the second study: levels of binding and neutralizing antibodies remain elevated three months after the second dose.
  • The public can attend the meeting of the Vaccine and Related Biologics Advisory Committee (VRBAC) virtually. VRBAC will meet from 9am to 6pm EST on 12/10 to review the application for an EUA from Pfizer and on 12/17 to review Moderna’s application. The entire dataset from the Pfizer vaccine trials will be available to the public on December 8 and for the Moderna vaccine on December 15.
  • In the Pfizer trials the rate of infection in the placebo groups was lower than expected, probably due to volunteer bias, and the efficacy of these vaccines may be a little lower when the general public receives them. On safety, two months of data in 40,000 people is reassuring that there are not common side effects that we need to worry about, but we won’t know about rare side effects until millions have been vaccinated. Good point to share with your patients. Watch this JAMA video interview with Dr. Paul Offit.
  • Additional talking points with patients can be found in this column in the New York Times which points out that immunity from the SARS-CoV-2 vaccine is at least equal to natural infection, but much safer.
  • You should also point out that patients (and staff) may miss a day of work due to the reaction to the vaccine. You might consider staggering immunization of your office staff for this reason.

Treatment

  • An interim analysis of the data on repurposed antiviral drugs for COVID-19 WHO Solidarity Trial was published in the NEJM on 12/2.
  • A randomized trial in 11,330 hospitalized adults with COVID-19 of four different drug regimens found that remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with COVID-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.
  • Nebulized interferon beta-1a was found to be safe and effective in a randomized phase II trial in 101 hospitalized COVID-19 patients in reducing the WHO Ordinal Scale for Clinical Improvement (OSCI) compared to placebo. The study was published in The Lancet on 11/12 and can be found here.

Telehealth

  • CMS announced on 12/1 that more than 60 services added to the Medicare telehealth list will continue to be covered beyond the end of the PHE, but also stated that *they did not have the statutory authority to pay for telehealth outside of rural areas or, with certain exceptions, allow beneficiaries to receive telehealth in their homes.
  • The AAAAI will continue to advocate to Congress to get this covered.
  • HHS announced that health care providers can provide telehealth across state lines during the PHE, regardless of state and local prohibitions.

Deadline For Applying For MIPS 2020 Hardship

  • The deadline to apply for a hardship exception for the 2020 performance year is December 31. Submit an application requesting reweighting of one or more MIPS performance categories. The application can be found here.
  • A reminder to our members: You must participate in MIPS (unless otherwise exempt) if, in both 12-month segments of the MIPS Determination Period, you: Bill more than $90,000 for Part B covered professional services, and; See more than 200 Part B patients, and; Provide more than 200 covered professional services to Part B patientsThus meaning if you do not meet those criteria, you do not exceed the low volume threshold. If you don’t exceed the low volume threshold, you may still voluntarily participate if you hope to qualify for increased Medicare reimbursement.

SARS-CoV-2 Mutations Do Not Appear To Increase Transmissibility

  • In this study published in Nature Communications published on 11/25 the authors studied 46,723 SARS-CoV-2 genomes isolated from patients worldwide. “We do not identify a single recurrent mutation in this set convincingly associated with increased viral transmission. Instead, recurrent mutations currently in circulation appear to be evolutionary neutral and primarily induced by the human immune system via RNA editing, rather than being signatures of adaptation.”

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


December 1, 2020

Here are today's important updates:

Vaccine News

  • AstraZeneca has reported vaccine trial preliminary results. Several media outlets reported on November 23 that the vaccine maker released interim data analysis indicating that their vaccine was 62% effective in one trial involving two full doses one month apart, and 90% effective in another trial that offered a half-dose followed by a full dose one month apart, for an average efficacy of 70% over the two trials. It has been reported that there were mistakes made in dosing in the half-dose trial and that trial enrolled younger patients.
  • Moderna has applied for an EUA for their vaccine, joining Pfizer who has already applied. There could be two vaccines available by the end of December.
  • The FDA Vaccine Advisory Committee is slated to meet December 8-10 to review data for the Pfizer application and will reportedly meet the following week for the Moderna application.
  • Once the EUA has been granted, U.S. officials announced plans to immediately release 6.4 million doses nationwide as an initial distribution. States have already been informed of their estimated vaccine allocations.

ACIP Releases Statement on Ethical Principles for Allocating Vaccine

  • The Advisory Committee on Immunization Practices (ACIP) published their ethical principles for allocating initial supplies of COVID-19 vaccine in MMWR on November 23.
  • The four principles are: 1) maximize benefit and minimize harms, 2) promote justice, 3) mitigate health inequities, 4) promote transparency.
  • Four groups have been considered for initial vaccine allocation: healthcare workers, other essential workers, adults with high-risk conditions and adults >65. Initial allocations of vaccine will not be enough to vaccinate all these groups, since there are 100 million healthcare workers alone, and only 20 million doses of vaccine will be available.
  • Despite this, HHS announced that governors will have the final say on who receives the vaccine first.

AMA Passes Resolution on Combating Misinformation About COVID-19 Vaccines

  • At the AMA Special Meeting in November, the House of Delegates directed the AMA to institute a program to promote the integrity of a COVID-19 vaccination program by: educating physicians on speaking with patients about COVID-19 vaccination, educating the public about the safety and efficacy of the vaccines, forming a coalition of healthcare and public health organizations, inclusive of those respected in communities of color to develop and implement an education program, and supporting ongoing monitoring of COVID-19 vaccines.
  • Allergists need to prepare their patients for the side effect profile of the two vaccines, which include fever, malaise and myalgias, to encourage them to get the second dose.

NIAID Announces New Treatment Trial

  • This will be the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4), which will be a randomized placebo controlled trial of remdesivir combined with either dexamethasone or baricitinib in hospitalized adults with supplemental oxygen requirements.

Convalescent Plasma Ineffective in COVID-19 Severe Pneumonia

  • As published in NEJM on November 24, a randomized, placebo-controlled trial in 228 patients with severe COVID-19 pneumonia demonstrated no significant differences in clinical status or overall mortality.

Predictors of Disease Severity in Hospitalized Children and Youth

  • A multicenter retrospective and prospective study on 281 hospitalized pediatric patients with acute COVID-19 and MIS-C published November 13 in The Journal of Pediatrics showed that patients with MIS-C were more likely to identify as non-Hispanic Black, and obesity and hypoxia on admission were predictive of severe respiratory disease. 41% of patients were admitted to the ICU, and 2% died. Lower absolute lymphocyte count and higher C-reactive protein were associated with more severe MIS-C.

Estimated Seroprevalence of SARS-CoV-2 in the United States

  • In this study published on November 24 in JAMA Internal Medicine, the authors collected serum samples used for screening labs from all 50 states, the District of Columbia and Puerto Rico and measured serology to SARS-CoV-2 every two weeks from July 27 to September 24. Seroprevalence varied from 0.0% to 23% over the time periods. In 42 of 49 jurisdictions with sufficient samples to estimate seroprevalence across all periods, fewer than 10% had detectable SARS-CoV-2 antibodies.
  • CDC model estimates that the actual number of COVID-19 cases is eight times the reported number.

FDA Approves Quantitative COVID-19 Serology Test

  • On November 23, the FDA granted an EUA to Kantaro Bioscience’s quantitative COVID-19 neutralizing antibody test. Most tests authorized to date are qualitative or semi-quantitative. This should allow for better epidemiologic studies and research on immune persistence post-infection and post-vaccine.

Prognostic Implications of Viral Load and Early Antibody Formation

  • SARS-CoV-2 viral load on admission (RT/PCR Ct <22) was associated with a significantly increased 30-day mortality (OR 4.20 [95% CI: 1.62-10.86]), and anti-SARS-CoV-2 nucleocapisid IgG seropositivity on admission trended toward a reduced 30-day mortality (OR 0.43 [95% CI: 0.15-1.26]). Reporting of quantitative SARS-CoV-2 viral load and serologic assays may offer prognostic clinical information.
  • The study was published online in Open Forum Infectious Diseases on November 3 and can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


November 23, 2020

Here are today's important updates:

Travel, Gatherings and Masks

  • The November 20 issue of MMWR reviews 86 primary, secondary and tertiary cases in the state of Minnesota, that resulted from attendance at the Sturgis motorcycle rally in South Dakota this summerOne-third of the counties in Minnesota had at least one primary, secondary or tertiary case. These numbers are likely to be an underestimate, since the case reviews were voluntary. We also don’t know the number of Minnesota residents who attended. Use this information to inform your patients how holiday travel and lack of mitigation measures can affect their communities and state.
  • second article in the same issue reviewed the effect of mask mandates in Kansas this summer. The governor of Kansas issued an executive order requiring wearing masks in public spaces, effective July 3, 2020, which was subject to county authority to opt out. After July 3, COVID-19 incidence decreased 6% in 24 counties with mask mandates, but increased 100% in 81 counties without mask mandates. Another example to share with your patients.
  • In case you hear about it, an article in Annals of Internal Medicine on an individually randomized controlled trial in Denmark this past spring did not show additional benefit from positive messaging to support wearing masks compared to physical distancing alone. Limitations of this study are that only 46% adhered completely to mask wearing, and the study only looked at the risk of infection for the mask wearer, but not the effect on transmission to others. The study was not designed to demonstrate whether masks reduce transmission or infection, but rather the impact of messaging surrounding mask wearing.
  • To quote Dr. Vin Gupta’s Tweet (ICU doc and MSNBC consultant): “An ICU bed is only as good as the trained nurse, RT, and doc available to staff it. We do NOT have enough trained staff to contend with unplanned surges after holiday travel nationwide. This headline out of Switzerland will be ours post-Thanksgiving if we don’t act in unison.”

Vaccine News

  • You probably already know that Pfizer has applied to the FDA for an EUA for their vaccine. Moderna is expected to follow soon with the same request. The FDA will likely rule on this in early December, so vaccine may be available by the end of the year, if the pilot distribution testing goes well. There are still many questions about distribution, although several national pharmacy chains have signed on as participants.
  • An interesting article on the Ethical and Scientific Considerations Regarding the Early Approval and Deployment of a COVID-19 Vaccine that was published on November 20 in the Annals of Internal Medicine covers issues related to other vaccine trials and impact on long-term safety and efficacy data.

Treatment News

  • WHO recommends against using remdesivir as a treatment for hospitalized patients with COVID-19. The article is entitled A Living WHO Guideline on Drugs for COVID-19 and has a nice visual representation of treatments. The FDA, earlier this year, granted an EUA for remdesivir for patients with COVID-19.
  • Ah, the confusing shortcomings of clinical trials in a pandemic.
  • The FDA has granted an EUA for the combination of baricitinib with remdesivir for hospitalized patients with COVID-19. In a clinical trial of hospitalized patients with COVID-19, this combination was shown to reduce time to recovery within 29 days compared to remdesivir plus placebo.
  • The FDA has granted an EUA for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age or older weighing at least 40 kilograms (about 88 pounds) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

HHS Updates on PRF FAQs

  • Updates added on November 18 relate to qualifying expenses for capital equipment and facilities projects. Basically, expenses for capital facilities and equipment may be fully expensed only in cases where the purchase was directly related to prevent, prepare for and respond to the coronavirus.

Risk for COVID-19 Among Healthcare Workers

  • BMJ has published results from their nationwide linkage cohort study on hospital admission risk for healthcare workers. The study involved 158,445 healthcare workers and 229,905 household membersThey divided the healthcare workers into patient-facing and non-patient facing and also subdivided the patient-facing into “front door”, ICU and aerosol-generating settings.
  • Patient-facing healthcare workers were over three times as likely as non-patient facing healthcare workers to be hospitalized for COVID-19, and their household members almost twice as likely.
  • Non-patient facing healthcare workers were at no greater risk than the general population.
  • To put this into perspective, the estimated absolute risk of hospitalization for patient-facing workers was <0.5%.

COVID-19 Rates Higher in Small Cities and Rural Areas

  • MMWR from November 20 shows data indicating that the incidence of COVID-19 in September and October was higher in rural and medium/small counties compared to large urban areas.

Cases in Children Rising

  • According to state level data collected by the AAP and Children’s Hospital Association, the number of cases of COVID-19 in children now exceed 1 million. There has been a 22% increase in cases over the last 2 weeks, with 185,829 new cases.
  • In the 10 states reporting, 3.9%-18.8% of children tested were positive.
  • In 23 states and New York City, 0.5%-6.1% of cases resulted in hospitalization.
  • In 42 states and New York City, mortality varied from 0.00%-0.15%.

CDC COCA Call on Telehealth and Health Equity

NEJM Webinar on COVID-19 Comorbidities and Cutaneous Manifestations of Systemic Diseases in Adults and Children

  • This webinar takes place Wednesday, December 2 from 1:00 to 2:15 pm ET. Register here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


November 17, 2020

Here are today's important updates:

Here We Go Again

  • As case numbers rise to their highest since the pandemic began, it is time to refocus on patient and staff safety. Review your PPE supply and supply chain. Make early purchases while items are available. Begin networking with others to purchase supplies. Review and refine your telemedicine protocols and schedules. As the percentage of positive tests climb, the likelihood of asymptomatic patients in your offices will also climb. Re-evaluate in-office procedures with this in mind. The AMA is once more collaborating with Project N95, a not-for-profit organization, to reserve more quality-certified PPE exclusively for AMA members to purchase with no minimum. If you’d like to place an order, go here to begin the process.

Holiday Travel

  • As you consider visiting relatives for the holidays, note that the November 13 MMWR reported on the results of airport symptom-based screening of incoming passengers to prevent the spread of COVID-19. From mid-January to mid-September, 766,044 travelers were screened and 298 (0.04%) met criteria for public health assessment. Of those, 35 (0.005%) were tested for SARS-CoV-2 and 9 (0.001%) were positive. Overall this resulted in about one case for every 85,000 travelers screened.
  • While this study concerned the screening of passengers arriving at certain airports from certain countries, the point that was made and echoed by the study of Marine recruits published in NEJM last week, is that symptom screening is not effective. The fact that this is done by your airline is not that reassuring.
  • A better approach is to advise our patients, and heed the advice ourselves, to follow known mitigation strategies and consider pre-departure and/or post-arrival testing.
  • If you are thinking about family gatherings at home, the CDC has posted information on how to do that safely.
  • If you are curious about your risk in attending a gathering, the Georgia Institute of Technology, in collaboration with the Applied Bioinformatics Laboratory and Stanford University, has developed this handy assessment tool.

FDA Webinar Series on Respirators and Other PPE

  • The FDA will be hosting a webinar on this topic on December 8 from 12:00 to 1:00 pm EST. Information on this webinar and others that have been held with available transcripts can be found here.

Vaccine News

  • Moderna announced on Monday that its vaccine was showing 94.5% efficacy in preliminary results from their phase 3 trial. Unlike the Pfizer vaccine, this one will not require the same storage issues and can be safely stored at -25 degrees Fahrenheit.
  • This site has some great infographics on how vaccines and other treatments work that allergists can use with their patients.

Vaccine CPT Codes

  • The AMA, in cooperation with CMS, has released new codes specific for the vaccines to be released. A spreadsheet of all the COVID-19 testing, vaccine and vaccine administration codes can be downloaded here.
  • The vaccine codes currently available are 91300 for the 30 mcg/0.3mL dosage, diluent reconstituted and 91301 for the 100 mcg/0.5mL dosage.
  • According to CMS: If you intend to administer the COVID-19 vaccines when they become available, or the new monoclonal antibody bamlanivimab, especially if you intend to roster bill these codes, please download and install the new release of PC-ACE. This release includes the coding structure, currently comprised of both a HCPCS Level I CPT code structure issued by the American Medical Association (AMA) and a HCPCS Level II code structure issued by CMS. Together, these codes support the administration of the COVID-19 vaccines and the monoclonal antibody infusions, as they become available; this structure includes the codes for bamlanivimab.

Monoclonal Antibody Coverage and Access

  • CMS has announced that Medicare will cover these infusions without cost sharing. They anticipate initially giving the antibody product to healthcare providers at no cost and payment will be made for infusion. When healthcare providers begin to purchase monoclonal antibody products, Medicare anticipates setting the payment rate in the same way it set the payment rates for COVID-19 vaccines. CMS will issue billing and coding instructions for healthcare providers in the coming days.
  • HHS promised to fairly and swiftly distribute the treatment, but there are only 88,000 doses available now. Logistics will be an issue for receiving and administration.

Treatment Update

  • A small randomized study on inhaled interferon beta-1a in 98 hospitalized patients with COVID-19 was published in The Lancet Respiratory Medicine. The odds of improvement were more than two-fold greater in treated patients compared to placebo at day 15 or 16 (OR 2.32). Inhaled interferon beta-1a reduced the odds of developing severe disease by 79% (OR 0.21), and patients were more than twice as likely to recover (OR 2.19).

CDC Issues Scientific Brief on Community Mask Wearing

  • In an updated (November 11) resource, the CDC lays out the latest scientific basis for community use of cloth masks to control the spread of SARS-CoV-2. They provide experimental and epidemiologic data to support that masks reduce transmission and protect the wearer.
  • Details can be found here.

Long-Term Outcomes of Hospitalized Patients With COVID-19

  • Research was published in Annals of Internal Medicine on November 11. The observational cohort study of 1,250 patients discharged after hospitalization in Michigan from March 16 to July 1 describes 60 day post-discharge clinical, financial and mental health outcomes. Only 488 patients were available for the 60 day survey.
  • Key findings: Of the 1,250, 78% went home, 12.6% to a SNF or rehab facility, 6.7% died and 15.1% were re-hospitalized. Of those available for the survey after 60 days, 32.6% had persistent cardiopulmonary symptoms (over half of these had new or worsening symptoms), 12% had problems with activities of daily living, and nearly half reported emotional impact.
  • In another study using data from the Premier Healthcare Database, investigators were able to track re-admissions to the same hospital in 126,137 patients who had been hospitalized for COVID-19. Of those, 9% were re-admitted in the two months following discharge, with 1.6% re-admitted multiple times.
  • Risk factors for readmission included age 65 years or older, COPD, chronic kidney disease, or discharge to a SNF or those having received home healthcare and hospitalization in the three months prior to their COVID-19 hospitalization.

Advantages and Trade-offs of COVID-19 Diagnostic Tests

  • A new rapid expert consultation from a standing committee of the National Academies of Sciences, Engineering, and Medicine examines four topics related to the use and interpretation of COVID-19 diagnostic tests. The topics are: advantages and limitations of reverse transcription polymerase chain reaction (RT-PCR) testing; the status of point-of-care (POC) tests; strategies and considerations for certain types and sequences of tests; and next-generation sequencing (NGS) testing.
  • One of several points made: POC test results are not always communicated to public health authorities, especially if performed by employers and universities.
  • The full report can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


November 11, 2020

Here are today's important updates:

Great Vaccine News

  • I am sure that all of you are aware of the news relating to the effectiveness of the Pfizer vaccine. It is important to remember that this is preliminary data that has yet to be reviewed, and the trial still has to complete the safety data.
  • Pfizer has announced that they will have 50 million doses ready to go when they get an FDA EUA, but there are still several logistical hurdles to overcome before this is ready for administration.

Important HHS PRF Update

  • HHS has once again updated the PRF FAQs, this time with respect to the Reporting Requirements.
  • This update clarifies that any lost patient revenue is NOT offset by any funds received for coronavirus-related expenses. Therefore, now, to determine if a provider should retain any PRF funds, the provider will first determine any healthcare related expenses attributable to coronavirus that another source has not reimbursed and is not obligated to reimburse, and then calculate any changes from 2019 in patient revenues. This clarification should ensure that most providers are eligible to retain a larger portion of the PRF funds.
  • The actual language from the update: At the bottom of page 1 of the reporting requirements announcement in PDF, Step 2 states “PRF payment amounts not fully expended on healthcare related expenses attributable to coronavirus are then applied to patient care lost revenues, net of the healthcare related expenses attributable to coronavirus calculated under step 1.” Is the underlined language still applicable under the reporting requirements notice that HHS posted on October 22, 2020? (Added 11/2/2020) Answer: No, healthcare related expenses are no longer netted against the patient care lost revenue amount in Step 2. A revised notice will be posted to remove this language.

Aerosol or Droplet Spread?

  • A study using differential equations to describe the evolution of respiratory droplets, using SARS-CoV-2 as an example, found that there is no apparent size boundary between expelled particles that fall to the ground quickly versus those that can remain airborne. The simulation showed that after 10 seconds of a cough, 5.1% of virus-containing particles were below the 5µm threshold used to designate classification of “airborne”, and 59.5% of these virus-containing particles were able to remain airborne. Masking, however, can effectively block around 94% of the viruses that may otherwise remain airborne after 10 seconds. The authors challenge the dichotomy of using aerosols and droplets to separate the modes of disease transmission.
  • The study can be found here.

Treatment Update

  • FDA just announced an EUA for Eli Lilly’s monoclonal antibody bamlanivimab for non-hospitalized COVID-19 patients older than age 65 or who have certain chronic medical conditions.

RT/PCR Testing After Recovery

  • Short-term recurrence of positive SARS-CoV-2 RNA was not likely to be a relapse of COVID-19 among patients who re-tested positive for SARS-CoV-2 RNA after being discharged from the hospital.
  • Overall 2.3% of RT-PCR positive samples with low or very low RNA levels were able to transmit infection in cell monolayers.
  • The study can be found here.
  • In a retrospective study of patients who tested positive for SARS-CoV-2 RNA after being discharged from the hospital, short-term recurrence of positive SARS-CoV-2 RNA was common (15%), and not associated with new symptoms. Patients with recurrent positive tests tended to be younger (34 vs. 45 years) and had a higher proportion of moderate symptoms during their hospitalization. All 192 patients who had recurrent positive tests showed no signs of infection and none of their close contacts developed COVID-19.

False Positive Antigen Tests for SARS-CoV-2

  • The FDA just sent a letter to clinical laboratories and health care providers concerning the potential for false positive results with antigen tests for rapid detection of SARS-CoV-2. This comes as the FDA is informed of false positive results in nursing homes and other settings. These are not unexpected when screening large populations with a low prevalence of infection. Recommendations: follow the package insert instructions precisely, minimize the risk of cross-contamination, avoid processing multiple specimens in batch mode, consider confirmation using RT/PCR depending on the degree of suspicion.

FDA Authorizes First Test That Detects Neutralizing Antibodies From Prior COVID-19

  • The cPass SARS-CoV-2 Neutralization Antibody Detection Kit received an EUA from the FDA. According to the FDA, “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

More on SARS-CoV-2 Immune Response

  • In our last message, we highlighted a review in Lancet on the immune response to SARS-CoV-2. In this month’s JACI: In Practice, there is a Clinical Commentary Review on age-related differences in the immune response to this virus.
  • Another study of children and adults with COVID-19 in New York found that there were different antibody responses between adult and pediatric populations, with adults showing anti-spike IgG, IgM and IgA antibodies as well as anti-nucleocapsid IgG antibody, while children had anti-spike IgG antibody but not any anti-nucleocapsid antibody.

Rates of COVID-19 Rising in Children

  • The AAP reported a record number of cases on COVID-19 in children, 61,447 new cases in the last week of October. There were about 200,000 new cases in the month of October. We have been worried about young adults, who make up the majority of new cases, transmitting the virus to the elderly, but perhaps we should also be concerned about transmitting it to their children.
  • This transmission concern is supported by a prospective cohort study in North Carolina, which found that 77% of children and adolescents living with a close household contact infected with SARS-CoV-2 had a positive SARS-CoV-2 RT/PCR test. Increased infection risk was associated with Hispanic ethnicity (OR=1.7) or having an infected sibling (OR=1.5), whereas asthma was associated with a lower risk. 81% of the children in the study were Hispanic, and represented 21% of those tested and 59% of those infected. 70% of the children had one or more symptoms. The study can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


November 3, 2020

Here are today's important updates:

AAAAI Advocacy Success

  • Due to the pandemic and the turmoil it has caused practices, the AAAAI signed on with other health care organizations encouraging CMS to delay the compliance date for the Cures Act Information Blocking provisions, as well as initial requirements related to application programming interfaces (APIs) to April 5, 2021New standardized API functionalities will not be required until December 31, 2022.

Cyber Crime Attacks

  • The FBI and other federal agencies are warning of “an increased and imminent cybercrime threat” to U.S. hospitals and healthcare providers. Cyber criminals are sending emails to hospital employees with attachments and links to websites. Clicking the links or opening the attachment launches ransomware. Please be extremely vigilant for any email with attachments or links that come from unexpected sources. Be especially careful when clicking on or opening any attachments in emails referencing COVID-19.
     
  • Resources for physicians can be found here.

Impact of COVID-19 On Physician Practice Viability

  • Results of a nationwide AMA survey of physicians show that 81% have reported a reduction in revenue, averaging 32%, with 20% of practices reporting reductions of 50% or more.
     
  • Similar numbers of practices have noted a reduction in patient volume with a 50% or greater decrease in patient visits for more than 1/3 of respondents, which was not completely compensated for by the increase in telehealth.
     
  • Practice expenses increased 50% or more for 40% of practices.
     
  • Over 1/3 of practices reported difficulties in purchasing PPE.

HHS Updates PRF FAQs (Again)

  • Highlights: Providers will be allowed to make corrections to their submitted data up to five business days after the submission deadline. If PRF funds were held in an interest bearing account, the interest earned must be returned if you return the funds. The address for returning checks is listed on this site. PRF payments can be used to support COVID-19 vaccine distributionFunds must be expended by 6/21/21. Refer to the site for a listing of healthcare expenses attributed to coronavirus as well as detailed examples of determining expenses.
     
  • Remember the deadline for applying for additional PRF funds is November 6.

Cases In Children

  • The American Academy of Pediatrics and the Children’s Hospital Association, in a report that compiles state-by-state data on COVID-19 cases in children, found that from Oct. 8 to Oct. 22, there were 94,555 new child cases reported (697,633 to 792,188), a 14% increase in child cases over two weeks. Stay up to date with current infection rates by accessing the report.
     
  • The AAP also released interim guidance on child care during COVID-19.
     
  • Transmission rates in households have been variable in publications to date, and some experts have stated that young children are not usually the source of infection in a household. In the MMWR published on October 30, a prospective household transmission study carried out in 191 households in Nashville, Tennessee and Marshfield, Wisconsin indicates that transmission of SARS-CoV2 was frequent (53%) and equal from either children or adults. This was a carefully done study in which enrolled household contacts self-collected samples daily for 14 days for RT/PCR testing. The types of samples did vary. Recommendations from the CDC based on this data: “Persons should self-isolate immediately at the onset of COVID-like symptoms, at the time of testing as a result of a high risk exposure, or at time of a positive test result, whichever comes first. All household members, including the index case, should wear masks within shared spaces in the household.”

Prior Negative SARS-CoV2 Testing Not Always Reassuring

  • In a report in the October 30 MMWR, a single high school student who was PCR negative one week before attending a retreat became symptomatic shortly after arrival. The attack rate among the susceptible attendees was 91%. Twenty-four of the students with positive serology prior to the retreat did not get infected. There were no hospitalizations or deaths.

COVID-19 Reinfection

  • There are now reports, in various journals, of eight cases of reinfection with SARS-CoV2 around the world. In one of two cases in the U.S., genomic analysis indicated a different strain causing the second infection. Most but not all of the second infections were milder. More details are likely to follow, but this has major implications for vaccine administration.

Treatment Update

  • Eli Lilly’s monoclonal antibody LY-CoV555, in an interim analysis of Phase 2 clinical trial data from non-hospitalized patients, showed a reduction in viral load and some decrease in symptoms compared to placebo with the 2800mg doseThe rate of hospitalization or ER attendance was 1.6% in the treated group compared to 6.3% in the placebo group.
  • Regeneron has released an analysis of data from their randomized, placebo controlled, phase 2/3 trial of their monoclonal antibody cocktail REGN-CoV2 in almost 800 non-hospitalized patients. It has also shown a more rapid reduction in viral load and a reduction in medical visits, including hospitalizations, ER or clinic visits compared to placebo.
     
  • Both studies showed increased effectiveness in high risk patients.
     
  • On the other hand, both Regeneron and Eli Lilly have stopped the trial of their monoclonal antibodies in hospitalized patients due to a safety concern and lack of effectiveness.
     
  • The effectiveness of convalescent plasma for COVID-19, although approved by the FDA, has been called into question based on the latest study.
     
  • Non-pharmaceutical interventions: A nationally representative survey (n=6,475) conducted in three waves from April to June 2020 found that self-reported mask wearing increased across survey waves, while handwashing, physical distancing, and cancelling social activities decreased. Avoiding some or all restaurants did not change significantly. While >40% of respondents reported following all recommended behaviors across all waves, engagement was lowest among adults aged 18-29 years and highest among those aged >60 years.

Vaccine News

  • A very useful review of the immunologic response to SARS-CoV2 infection and its relationship to vaccine development was just published in Lancet. The article explains why multiple vaccines may be needed across different populations. A pdf of the article can be downloaded here.
     
  • CMS announced that any FDA approved vaccine for COVID-19 will be covered under Medicare at no cost. The vaccine will be given to providers to administer free of charge, and Medicare will reimburse the provider for the cost of administration. Patients may not be charged for administration.
     
  • CMS also issued an interim final rule with comment (IFC) which implements provisions of the CARES Act that ensure swift coverage by most private health insurance plans without cost sharing from both in and out-of-network providers during the PHE.
     
  • This IFC also requires that any provider who performs a COVID-19 diagnostic test must post their cash prices online.
     
  • State Medicaid and CHIP agencies must provide vaccine administration with no cost-sharing for most beneficiaries during the PHE.
     
  • For uninsured patients, providers will be able to be reimbursed for administration through the Provider Relief Fund.
     
  • CMS has issued toolkits for providers which give the information needed to administer and bill for the vaccines. In an effort to recruit more providers to administer the vaccines, new providers are now able to enroll as a “Medicare mass immunizer” through an expedited process, although this may not apply to allergists.
     
  • Reimbursement for administration of the vaccines are $28.39 for a single dose vaccine, and for a two dose: $16.94 for the first dose and $28.39 for the second.

Updates To AAAAI COVID-19 Resource Web Page

  • Results from an AAAAI survey on spirometry use in academic medical centers can be found on the web page.
     
  • New updated infographics for patients in English and Spanish are now available on the Patient Information section. These can be downloaded and shared with your patients.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


October 27, 2020

Here are today's important updates:

Modeling Reinforces Benefit of Mask Wearing and Social Distancing

  • In a study published in Nature Medicine on October 23, an Institute of Health Metrics and Evaluation (IHME) model suggests that universal mask use in the United States could save an additional 129,574 lives from September 22 through the end of February 2021, or an additional 95,814 lives assuming 85% mask adoption, when compared to the reference scenario.
  • The modelers also point out that current state strategies about social distancing, phased reopening and mask mandates could lead to over 500,000 deaths by the end of February.
  • Another model on social distancing in Annals of Internal Medicine evaluated the overall effect of social distancing, as well as the effect of timing and adherence. The authors conclude that social distancing can have a substantial effect on cumulative cases of COVID-19.

CMSS Issues Statement Condemning President Trump's Statement About Physicians Overcounting COVID-19 Deaths

  • The Council of Medical Specialty Societies (CMSS), of which the AAAAI is a member, issued a strong statement this week condemning the President’s statement that doctors were overcounting COVID-19 deaths for financial or political gain. Read the statement here. In addition to CMSS, other organizations released statements, including the American Medical Association (AMA), American College of Obstetricians and Gynecologists (ACOG), American College of Emergency Physicians (ACEP), and American College of Physicians (ACP).

Excess Deaths Don't Only Affect Older Adults

  • There has been a lot in the press lately about excess deaths. The issue of Morbidity and Mortality Weekly Report published on October 23 notes that at least two out of three of these excess deaths were from COVID-19 and the largest percentage increase in excess deaths occurred among Hispanic or Latino persons and adults aged 25 to 44.

CDC Issues New Guidance Defining "Close Contact"

  • The new definition includes exposure to a confirmed or likely case of COVID-19 for a total of 15 minutes or more over a period of 24 hours.

Asymptomatic Children Have Lower Viral Load

Repeat Testing Not Helpful in Low Prevalence Situations

  • In a population of 5,000 patients with symptoms in an area with a low prevalence of SARS-CoV-2 infection, repeat testing of negative patients who had persistent symptoms still yielded a negative result in 96% of cases. Read more details here.

What Factors Are Associated With SARS-CoV-2 Vaccine Effectiveness?

  • A survey (JAMA Netw Open 2020; 3(10):e2025594) of 1,971 U.S. adults found that attributes such as vaccine efficacy, adverse effects, duration of protection, Food and Drug Administration (FDA) approval process, national origin of the vaccine, and endorsements were associated with preferences for choosing a vaccine. Other factors include healthcare attitudes and practice, political partisanship, and demographic characteristics.

Other Vaccine News

  • Both AstraZeneca and Johnson & Johnson announced that they have resumed their vaccine Phase 3 clinical trials in the United States.
  • In a sobering article, the New York Times published a report reminding all of us about the “monumental task” healthcare experts face in determining whether a variety of serious healthcare issues are due to the vaccines or not, as millions are vaccinated in the upcoming months.
  • There is a nice discussion on Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials in an article published online October 22 in Annals of Internal Medicine.

Cigna Announces Extension of Telehealth Coverage

  • Effective January 1, 2021, Cigna’s new policy for commercial plans “ensures participating providers in the Cigna medical network can continue to receive reimbursement on parity for virtual services that are typically performed in an office.” These include routine check-ups and new patient exams.

AMA Article Stresses Importance of Key Role of Physicians in Promoting Vaccine Acceptance

  • The AMA published a helpful article on October 23 outlining reasons why physicians are important in convincing patients about the importance and safety of vaccines for SARS-CoV-2, as well as actions we can take now.

Herd Immunity Acquired Through Infection Isn't the Answer

  • Read this article in Nature that was published online on October 21, which discusses the false promise of herd immunity for COVID-19.

Influenza and COVID-19

Updates to the HHS Provider Relief Fund

  • In an effort to support additional practitioners during the pandemic, the Department of Health and Human Services (HHS) announced today an expansion of eligible providers for Phase 3 funding, which includes allopathic and osteopathic physicians regardless of whether they accept Medicare or Medicaid.
  • The deadline to apply is November 6 for a baseline payment of approximately 2% of annual revenue from patient care plus an add-on payment that considers changes in operating revenues and expenses from patient care.
  • HHS is amending the reporting instructions to increase flexibility around how providers can apply Provider Relief Fund money toward lost revenues attributable to COVID-19. After reimbursing healthcare-related expenses attributable to COVID-19 that were unreimbursed by other sources, providers may use remaining Provider Relief Fund money to cover any lost revenue.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


October 20, 2020

Here are today's important updates:

CMS Examining CLIA Certifications

  • Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under Clinical Laboratory Improvement Amendments (CLIA).
  • Since August 12, 2020, the Centers for Medicare and Medicaid Services (CMS) issued 171 cease and desist letters to entities across the United States that were testing for COVID-19 without an appropriate CLIA certificate. Of those 171 letters, 34% went to facilities conducting laboratory testing without a CLIA certificate and 66% were issued to laboratories performing COVID-19 testing outside the scope of the existing CLIA certification.
  • If your office needs to obtain CLIA certification, here is the site to get started.

FDA Issues EUAs for New COVID-19 Tests

  • According to an article in Bloomberg that was summarized in the American Medical Association (AMA) Morning Rounds, the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Access Bio’s rapid, self-contained single use COVID-19 testwhich is similar to an at-home pregnancy test.
  • According to a summary of a TIME article, the FDA has issued an EUA for a test called SalivaDirect that doesn’t require a special container, any standard sterile container will do. This test is run in a CLIA certified lab and requires the patient spit in the presence of a healthcare professional.

SARS-CoV-2 Immunity

  • In a study from Germany among a group of convalescent potential blood donors, the researchers found evidence for T-cell immunity against SARS-CoV-2 in 78% of volunteers who had a confirmed infection but undetectable antibodies. A similar frequency (80%) of T-cell immunity was observed in donors with strong antibody responses, but was not found in negative controls.
  • The article can be read here under expedited articles.

Physicians Need to Promote SARS-CoV-2 Vaccination

  • On a recent AMA call for healthcare providers, public health specialists from the Centers for Disease Control and Prevention (CDC) cited research indicating that personal healthcare providers are a resource people trust the most regarding vaccines, so they will be asking for physician engagement in encouraging and administering vaccines as they become available, especially for vulnerable populations.
  • Trust for America’s Health is holding a webinar on October 21 at 1:00 pm EDT on Ensuring COVID-19 Vaccine Access, Safety and Utilization: Building Vaccination Confidence in Communities of Color. You can register here.

Duration of Infectiousness in Individuals With COVID-19

  • A review in the The Journal of Infection published on October 9 notes: “The detection of SARS-CoV-2 via culture among patients with COVID-19 illness was highly unlikely beyond 10 days of symptom onset in patients with mild-to-moderate disease. In a systematic review of 15 studies with more than 800 patients (5 studies did not specify sample size), the authors estimate that only six out of 217 patients had culturable virus beyond 10 days. For patients who were immunocompromised or with severe-to-critical COVID-19 illness, SARS-CoV-2 could be isolated for up to 32 days following onset of symptoms.”
  • The article can be found here.

Latest Expansion in Telehealth Services

  • CMS announced 11 new services were added to the Medicare telehealth services list on October 14. Of importance to allergists is that cardiac and pulmonary rehabilitation services are included.
  • These new services will be covered through the end of the public health emergency. The other services can be found here.
  • To further drive Medicaid and CHIP telehealth use, CMS released a new supplement to its Telehealth Toolkit, which is intended to help states plan and explain temporary versus permanent changes, identify services that can be accessed through telehealth, by whom and how these services can be delivered, and circumstances under which these services can be paid once the public health emergency expires.

HHS Adds Information to Provider Relief Fund Reporting Requirements

  • Final reporting requirements do not apply to Health Resources and Services Administration (HRSA) Uninsured Program reimbursement receipts.

Risk of Contracting SARS-CoV2 During Hospitalization

  • Among 101,533 patients hospitalized for a non-COVID-19 related illness included in a global research database representing 45 healthcare organizations, only 44 (0.043%) tested positive for SARS-CoV-2 within 14 days of discharge.
  • Implications: The risk of contracting COVID-19 during a hospital admission is low.
  • The article can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


October 14, 2020

Here are today's important updates:

FDA Guidelines for Vaccine Emergency Use Authorization

  • The Food and Drug Administration (FDA) guidelines for approval of a SARS-CoV-2 vaccine, after some controversy, have been released and can be found here.
  • The guidelines specify, among other things, evidence for clinical efficacy as well as safety. To quote the guidelines: "Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect.

AMA Webinar on FDA Review Process for Vaccine Candidates

  • A recording of the American Medical Association (AMA) webinar interviewing Peter Marks, MD, PhD, from the FDA on October 7 was recorded and is available for viewing here

Two COVID-19 Trials Delayed

  • In a story from Medscape, Johnson & Johnson announced a pause in their vaccine trial due to an adverse event. Eli Lilly also announced a pause in their trial of a monoclonal antibody for inpatients with COVID-19 for similar reasons.

First U.S. Patient To Be Reinfected Reported

  • A man in Nevada is the first U.S. patient to have documented reinfection with SARS-CoV-2. He was first positive in April, with two negative tests in May, followed by a positive test in June. There were significant genetic differences in the viral strains.
  • The case report was published October 9 in Lancet Infectious Disease.

AMA Adds New CPT Codes for Viral Testing

  • Now released for immediate use, these codes are for nucleic acid testing for SARS-CoV-2 plus other respiratory viruses.
  • 87636: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique
  • 87637: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique
  • They also revised codes for antigen detection by immunoassay for SARS-CoV-2 and added a new one—87811: Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

Assistant Secretary for Preparedness and Response & Technical Resource, Assistance Center and Information Exchange Release PPE Preservation Planning Toolkit

  • The fact sheet can be found here, along with links to the guide and spreadsheet.
  • This is designed to aid any PPE-using organization to plan and implement preservation strategies.

NIH to Launch Serological Sciences Network

  • Using funding from the Paycheck Protection Program and Health Care Enhancement Act, the National Institutes of Health (NIH) has launched this network of more than 25 of the top academic, government and private sector biomedical research institutions to study the immune response to COVID-19 to “speed delivery of testing, treatments and vaccine development.”

New Treatment Trial

  • The NIH announced an international clinical trial to test the safety and efficacy of hyperimmune IVIG plus remdesivir in hospitalized adults with COVID-19 (ITAC Trial). The National Institute of Allergy and Infectious Diseases is sponsoring and funding the study.

CMS Announces New Repayment Terms for Medicare Accelerated and Advance Payment Program

  • Repayment will now be delayed until one year after the payment was issued. After that first year, Medicare will automatically recoup 25% of Medicare payments otherwise owed to the provider for 11 months. At the end of the 11 month period, recoupment will increase to 50% for another six months.
  • If the provider is unable to repay the total amount of the Accelerated and Advance Payment within this time frame, the Centers for Medicare and Medicaid Services (CMS) will issue letters requiring repayment of any outstanding balance, at an interest rate of 4%.
  • The letter will also provide guidance on how to request an Extended Repayment Schedule if you are experiencing financial hardship. This would be a three to five year installment debt repayment plan.
  • In a reversal to what was said last week, Provider Relief Funds CANNOT be used to repay the loan.
  • Details can be found here.

HHS Updates Provider Relief Fund FAQs

  • On October 12, the Department of Health and Human Services (HHS) updated their FAQs for the Provider Relief Fund, one of which related to delaying audit submission dates but the rest concerned Phase 3 issues.
  • Details can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


October 8, 2020

Here are today's important updates:

HHS Extends Public Health Emergency

  • On October 2, Department of Health and Human Services (HHS) Secretary Alex Azar approved the extension of the public health emergency from the current end date of October 23 to January 23, 2021Read the announcement.

CDC Updates Guidance on Transmission of COVID-19 and Other Guidance

National Academies Release Final Report on Equitable Distribution of COVID-19 Vaccine

  • The CDC and Food and Drug Administration (FDA) tasked the National Academies of Medicine, Sciences and Engineering to develop a Framework for Equitable Distribution of COVID-19 Vaccine. The final report has been released and a summary has been posted here on the AAAAI COVID-19 resources page (under the Vaccines heading).
  • The Framework lists the ethical and procedural principles, goal and allocation criteria followed by the group.
  • Four allocation phases are recommended as follows: Phase 1a) high-risk healthcare workers and first responders; Phase 1b) people with significant comorbid conditions (two or more) and older adults in congregate or overcrowded settings; Phase 2) teachers and school staff, critical workers in high-risk settings, people with moderate comorbid conditions, people in homeless shelters, or group homes and staff, incarcerated/detained people and staff, and all older adults; Phase 3) young adults, children, and workers in industries important to the functioning of society; Phase 4) all other individuals in the United States who want it.
  • Equity is a crosscutting consideration: In each population group, vaccine access should be prioritized for geographic areas identified through CDC’s Social Vulnerability Index or another more specific index."

More Vaccine News

  • An article published October 1 in Health Day News quoted the CEO of Moderna as stating, "Moderna will not be ready to seek U.S. approval for the vaccine to be used in the general population until at least late January. If it is proven safe and effective, the vaccine is not likely to be available for nationwide use until later March or early April." This was also covered by CBS News.
  • According to an article published online September 29 in The New England Journal of Medicine, the results from trials of the same vaccine noted safety and immunogenicity in older adults.

FDA Revokes Individual and Umbrella EUA for Rapid SARS-CoV-2 Antibody Testing

  • The individual Emergency Use Authorization (EUA) was specifically revoked for Autobio’s Anti-SARS-CoV-2 Rapid Test and the FDA also revoked the umbrella EUA for all rapid SARS-CoV-2 antibody tests, although individual manufacturers can apply for their own EUA. Read more details.

Portal for Phase 3 Provider Relief Funds Now Open

  • See the AAAAI COVID-19 advocacy page for updates. Be sure to clear your cache at each visit to get the latest information.
  • The deadline to complete an application is November 6. Early application is encouraged to expedite the calculation and distribution of payments.
  • Refer to the FAQ page, which has been updated to reflect questions concerning Phase 3.
  • Eligible providers include all who were eligible for a previous Provider Relief Fund distribution, plus new 2020 providers.
  • Providers may be eligible regardless of whether they were eligible for, applied for, received, accepted or rejected payment from prior Provider Relief Fund distributions.
  • Receipt of Small Business Administration funds does not preclude eligibility for this distribution.
  • Phase 3 General Distribution supports providers who have been most significantly impacted by COVID-19, as measured by changes in their revenues and expenses from patient care.
  • If a provider did not previously receive approximately 2% of annual revenues from patient care, they will receive this amount consistent with prior general distributions, plus their Phase 3 allocation.
  • Payments received in prior Provider Relief Fund distributions will be considered when calculating a provider’s Phase 3 payment.

CDC Reports Case Series of Adults With Multisystem Inflammatory Syndrome

  • The Morbidity and Mortality Weekly Report from October 2 presents information on 27 adults patients who were either directly referred to the CDC or from case reports or series published in the peer-reviewed literature.
  • These patients had cardiovascular, gastrointestinal, dermatologic, and neurologic symptoms without severe respiratory illness and concurrently received positive test results for SARS-CoV-2, the virus that causes COVID-19, by polymerase chain reaction or antibody assays indicating recent infection.
  • Signs included markedly elevated inflammatory markers and markers of coagulopathy (D-dimer).
  • Many patients require ICU care and fatality is possible.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


October 5, 2020

Here are today's important updates:

AMA Announces Webinar Series on COVID-19 Vaccine Development

  • The first episode is Wednesday, October 7 at 2:00 pm CDT, where American Medical Association (AMA) President Susan R. Bailey, MD, FAAAAI, will speak with Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), and will cover the vaccine review processRegister here.
  • This will be followed by another webinar on October 13 at the same time, covering the Centers for Disease Control and Prevention (CDC) Update on COVID-19 Vaccine Development and Distribution.

HRSA Issues Proposed Rule to Improve Access to EAIs

  • The Health Resources and Services Administration (HRSA) has issued a proposed rule that Federally Qualified Health Centers who purchase epinephrine auto-injectors (EAIs) through the 340B program must have practices that make these drugs available to eligible patients at the discounted price paid under the 340B program.
  • Eligible patients include those with incomes below 350% of the federal poverty level and have health insurance with a deductible or co-pay or who have no health insurance.
  • The rule is subject to a 30-day comment period.

$20 Billion in New Phase 3 Provider Relief Funding

  • The Department of Health and Human Services (HHS) announced the availability of this new funding for providers. Those that have already received Provider Relief Fund payments can apply for additional funding that considers financial losses and changes in operating expenses due to the pandemic. Previous ineligible providers, such as those who started practice in 2020, can now apply. The application process begins on October 5 and ends November 6Early applications are encouraged to ensure rapid distribution of the funds by HHS.
  • This would be an add-on payment over and above the 2% annual revenue limitation for Phase 1 and 2 distributions.
  • Further details can be found here.

UnitedHealthcare Updates Telehealth Policy

  • We noted in a previous message that UnitedHealthcare (UHC) would change their telehealth policies effective October 1 based on a news article in STAT and previous UHC announcements. On October 1, UHC posted a reimbursement policy update with changes related to various UHC plans, including cost sharing waivers for COVID-19 diagnoses and non-COVID-19 diagnoses, billing instructions, originating sites, as well as coverage for audio-visual, audio only visits. Visit this site to determine the varying expiration dates depending on plans, which differ for diagnosis and in-network vs. out-of-network providers.

COVID-19: Optimizing Healthcare PPE and Supplies

  • The Office of the Assistant Secretary for Preparedness and Response hosted a webinar about personal protective equipment (PPE) preservation strategies, trends, challenges and lessons learned/promising practices on September 24. Access the recorded webinar.

AAP Releases Guidance For COVID-19 Testing For Children

  • The guidance, which is essentially the same as adult guidance, can be found here.

NIH Adds Further Funding to Support Testing For Underserved Communities

  • In a previous message, we noted the $12 million award from the National Institutes of Health (NIH) to RTI International to support a research effort on community education and awareness for the underserved in 11 states.
  • On September 30, the NIH announced awards totaling $234 million to improve COVID-19 testing for the underserved and vulnerable populations. This is a part of the Rapid Acceleration of Diagnostics (RADx) initiative, called the RADx Underserved Population (RADx-UP) program, which will support 32 institutions across the United States and will focus on populations disproportionately affected by COVID-19. In addition to ethnic groups that are at increased risk, this also includes older adults, pregnant women, the homeless and incarcerated. Details can be found here.

More NIH Research on SARS-CoV-2 Treatment

  • In this research bulletin, the NIH noted that researchers have designed synthetic “miniproteins” that bind tightly to the SARS-CoV-2 spike protein and prevent infection of cells in vitro.
  • These miniproteins appeared to work as well as monoclonal antibodies, are much easier to produce, are more stable, and could be delivered nasally.

Is Poor Outcome in Adults Related to the Quality of the Adaptive Immune Response?

  • Recent literature has postulated that one of the reasons children with COVID-19 fare better is that they have a more robust adaptive immune response.
  • This paper, published in Science Translational Medicine on September 21, compared immune responses between 65 patients <24 years of age to 60 patients >24 years at a metropolitan hospital system in New York City. The pediatric patients had milder disease in general. While concentrations of IL-17A and interferon gamma were inversely related to age, the adults mounted a more robust T cell response, serum neutralizing antibody titers and antibody-dependent cellular phagocytosis were higher in adults.
  • The authors concluded that based on these findings, the poor outcome in adults may not be attributable to failure to generate adaptive immune responses.

Check Your Hand Sanitizer Supply

  • The list on the FDA website now contains 196 products. The overwhelming number were manufactured in Mexico, but distributed by U.S. companies. There are also products listed that were manufactured in Guatemala (Genesis Partnership Co SA), Turkey and the United States (Leiper’s Fork Distillery, Tennessee; Open Book Extracts, North Carolina; Santa Cruz Biotechnology, Texas; SG24 LLC, Georgia; Volu-Sol, Inc, Utah). Most were contaminated with methanol or 1-propanol, or manufactured in the same plant as the contaminated product, but some contained subpotent concentrations of approved product or had microbial contamination.

Faulty KN95 Masks

  • USA Today reported on September 23 that 60-70% of KN95 masks do not meet National Institute for Occupational Safety and Healt (NIOSH) filtration standards.
  • It can be very difficult to determine if the masks that you buy are truly NIOSH certified or an equivalent. You cannot trust the manufacturer’s testimony. Most of the KN95 masks that are imported from China do meet Chinese specifications, which are very similar to NIOSH criteria.
  • The organization that USA Today quoted did mention that KN95 masks that come with ear loops do not, by definition, meet NIOSH criteria and 90% of the masks that they tested had ear loops.
  • A list of approved KN95 masks can be found on the CDC/NIOSH website.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


September 30, 2020

Here are today's important updates:

Coverage for Telehealth Changing October 1

  • STAT article reports that UnitedHealthcare (UHC) is ending a “virtual visit” benefit and Anthem is stopping waivers of copays, coinsurance and deductibles for virtual visits not related to COVID-19. According to the UHC website, virtual visits will be covered when you use one of the provider groups in the Virtual Visits network (Teladoc, American Well and Doctor on Demand).
  • These changes take place October 1.

Changing Age Distribution of COVID-19 Pandemic

  • This is probably not new news for you, but the Morbidity and Mortality Weekly Report from September 23 notes that during June-August of this year, COVID-19 incidence in persons ages 20-29 years accounted for >20% of all confirmed cases, the highest of all age groups.
  • Across the southern United States in June, increases in the percentage of positive SARS-CoV-2 tests among adults ages 20-39 preceded increases among those aged 60 and over by 4-15 days, suggesting that the younger adults were spreading disease to older contacts.
  • Children are making up a larger percentage of the cases as well. They now represent about 10% of COVID-19 cases in the United States, up from 2.2% in April according to data collected by the American Academy of Pediatrics and Children’s Hospital Association and published yesterday in Pediatrics.

Why Severe Disease?

  • National Institutes of Health scientists and their collaborators found that more than 10% of people who develop severe disease have neutralizing autoantibodies against type I interferon. Another 3.5% or more carry a specific mutation that impacts immunity. Both groups lack effective immune responses that depend on type I interferon.
  • More information can be found here.

How Many COVID-19 Patients Are Really Asymptomatic?

  • The study results are all over the map and depend on the setting of the study. In a review and meta-analysis of 79 studies through June 10 that was published online in PLOS Medicine on September 23, the authors noted that 20% (95% confidence interval 17-25%, prediction interval 3-67%) of people with SARS-CoV-2 infection remained asymptomatic during follow-up, but biases in study design limit the certainty of the estimate.
  • In seven studies of defined populations, 31% were asymptomatic and remained so.
  • Some evidence noted that infection in contacts of asymptomatic people is less likely (RR 0.35).

Vaccine News

  • Save the date of October 7 at 3:00 pm EDT for Episode 1 of an American Medical Association webinar series on COVID-19 Vaccine Development – What Physicians Need to Know. This episode will cover the Food and Drug Administration review process for vaccine candidates. Registration information will be coming soon.

Items of Interest in Pending Legislation

  • The Senate is scheduled to vote next week on the stopgap measure to continue funding the U.S. Government, H.R. 8337.
  • The measure would extend the time in which healthcare providers must repay the Medicare accelerated and advanced payments, and reduce the interest rate to 4% until the public health emergency ends.
  • The House released its pared down version of the HEROES Act this week, which may be voted on later in the week. The spending amount on the bill was reduced by shortening the duration of many of the changes and now stands at $2.2 trillion. This bill would impact the Paycheck Protection Program, Economic Injury Disaster Loans, Medicare, Medicaid, private insurance provisions, vaccine development and distribution, add an additional stimulus check, and restore the expanded unemployment payments through January. This has yet to be passed by the House, and will need to get through the Senate.

CRS Not a Risk Factor For Severe COVID-19

  • In an article published online in JACI: In Practice on September 24, researchers from China found that the prevalence of hospitalized COVID-19 patients with chronic rhinosinusitis (CRS) in a cohort from Wuhan, China was slightly less than the prevalence in the general population in China, suggesting that this condition is not a risk factor for severe disease.

National Academies of Sciences and Medicine Release Statement on Political Interference in Science

  • The National Academies of Sciences and Medicine released the following statement on September 24: “As advisers to the nation on all matters of science, medicine, and public health, we are compelled to underscore the value of science-based decision-making at all levels of government. Our nation is at a critical time in the course of the COVID-19 pandemic with important decisions ahead of us, especially concerning the efficacy and safety of vaccines. Policymaking must be informed by the best available evidence without it being distorted, concealed, or otherwise deliberately miscommunicated. We find ongoing reports and incidents of the politicization of science, particularly the overriding of evidence and advice from public health officials and derision of government scientists, to be alarming. It undermines the credibility of public health agencies and the public’s confidence in them when we need it most. Ending the pandemic will require decision-making that is not only based on science but also sufficiently transparent to ensure public trust in, and adherence to, sound public-health instructions. Any efforts to discredit the best science and scientists threaten the health and welfare of us all.”

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


September 22, 2020

Here are today's important updates:

CDC Updates Testing Guidelines

  • In response to widespread criticism about their last recommendations, the Centers for Disease Control and Prevention (CDC) has updated its guidelines for testing to include asymptomatic individuals who have had contact with a confirmed case of COVID-19 (closer than six feet for more than 15 minutes), as well as those that have symptoms consistent with COVID-19 and those who are referred by their healthcare provider. If you do get tested, you need to self-quarantine/isolate until tests results are known.
  • The guidelines can be found here.

Review on SARS-CoV-2 Transmission

Vaccine News

  • We announced in our last message that the Oxford/AstraZeneca vaccine trial had restarted, but actually that is only true for the European Union. It is still on hold in the United States pending Food and Drug Administration (FDA) evaluation.

Provider Relief Fund Updates

  • The Department of Health and Human Services (HHS) has released information on its reporting requirements, which can be found here. As a reminder, in July, HHS provided additional clarity regarding the reporting requirements. These revised requirements still have lowered the threshold, from $150,000 in the Terms and Conditions to $10,000 in the notice. In addition, the notice altered the timeframe for reporting, from 10 days after each calendar quarter to two new reporting deadlinesAll recipients must submit a report by February 15, 2021, and this can be a final report if all funds have been expended by December 31, 2020. Otherwise, the final report deadline is July 31, 2021. The portal for report submission will be open as of October 1, 2020.
  • TIN validation issues: If the TIN is subsequently marked as valid, the provider will be notified to proceed submitting data into DocuSign even if validation occurs after the September 13, 2020, deadline. Applicants validated after that date will have until September 21, 2020, to start an application and must complete and submit an application by September 28, 2020, to be considered for funding under Phase 2. TINs that cannot be validated will not receive funding. Please note, the additional TIN validation may result in a delay in processing the application. When is the deadline to submit an application? (Modified 9/17/2020) The deadline to submit a TIN for validation for the Phase 2 – General Distribution is September 13, 2020. Applications must be started by September 21, 2020, and submitted by September 28, 2020. Applications that are not completed by September 28 will be voided. Will healthcare providers that have not had their TINs validated by the application deadline of September 13, 2020, be able to submit an application after that date? (Modified 9/17/2020) Yes. A healthcare provider must submit their TIN for validation by end of day September 13, 2020. If they receive the results of that validation after September 13, they must start an application by September 21 and submit the application by September 28 for consideration under Phase 2. Applications that are not completed by September 28 will be voided.

CDC Announces COVID-19 Science Update

  • The CDC has created this series which provides brief summaries of new COVID-19 related studies on epidemiology, clinical treatment and management, laboratory science and modeling, and more. The update can be found here.
  • These summaries are released on Tuesdays and Fridays.

NIH Funds Community Engagement Research

  • On September 16, the National Institutes of Health (NIH) announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic.
  • The awardee—RTI International, a non-profit research institution—will support Community Engagement Alliance (CEAL) Against COVID-19 Disparities teams in 11 states.
  • The teams will focus on COVID-19 awareness and education research among populations most impacted by COVD-19, and will also promote and facilitate the inclusion and participation of these groups in vaccine and therapeutic trials.
  • States included: Alabama, Arizona, California, Florida, Georgia, Louisiana, Michigan, Mississippi, North Carolina, Tennessee and Texas.
  • More details can be found here.

IDSA Publishes Guidelines on the Use of Serologic Testing

  • The Infectious Diseases Society of America (IDSA) has published evidence-based guidelines on the use of serologic testing in the diagnosis of COVID-19 to help guide clinicians, and others, in decisions related to the “optimal use of SARS-CoV-2 serologic tests”.
  • The article can be found here.
  • Conclusions: "The panel identified three potential indications for serologic testing: 1) evaluation of patients with a high clinical suspicion for COVID-19 when molecular testing is negative and at least two weeks have passed since symptom onset; 2) assessment of MIS-C in children; and 3) for conducting serosurveillance studies. The certainty of available evidence supporting the use of serology for either diagnosis or epidemiology was, however, graded as very low to moderate."

2020-2021 Influenza

  • Widespread concern has been expressed about the coincident occurrence of influenza and SARS-CoV-2 this fall and winter. There is potential good news from the flu activity in the southern hemisphere during their winter this year.
  • In the September 18 issue of the Morbidity and Mortality Weekly Report (MMWR)following widespread adoption of community mitigation measures there were only 51 influenza positive specimens among 83,307 tested from April-July 2020 in Australia, Chile and South Africa (0.06%) compared to 13.7% positive in the same time period in 2017-2019.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


September 15, 2020

Here are today's important updates:

Hand Dermatitis Advice From the American Contact Dermatitis Society

  • This society has written a practical article relative to prevention and treatment of hand dermatitis during COVID-19. Allergists will find it useful in counseling patients, staff and for their own information.
  • The pre-proof article can be found here.

Is It Flu or COVID-19?

  • A cohort study of 315 children with COVID-19 and 1,402 children with seasonal influenza at Children’s National Hospital this past spring showed that rates of hospitalization, ICU admission rates and ventilator use were no different between the groups. Asymptomatic COVID-19 children tested pre-admission or pre-procedure were excluded.
  • No patients were hospitalized with coinfection, and there was a sharp decrease in influenza cases after local school closures and stay at home orders.
  • Patients hospitalized for COVID-19 were older (mean age 9.7 versus 4.2 years). Patients over 15 years accounted for 37% of hospitalizations (versus 6% for influenza).
  • Sixty-five percent of hospitalized COVID-19 patients had an underlying medical condition compared to 42% with influenza, with developmental delay or seizures most common. There was no significant difference in patients reporting a history of asthma.
  • Fever was the most common reported symptom in both groups, followed by cough. A greater proportion of patients hospitalized with COVID-19 reported fever, diarrhea or vomiting, headache, body ache or myalgia and chest pain. There was no significant difference in cough, congestion, or shortness of breath.
  • It is reassuring to know that asthma patients were not at higher risk for hospitalization, but this study points out the difficulty in differentiating these two illnesses so rapid, reliable testing will be required for both.
  • Allergists may have to rethink how they handle these patient calls this fall and winter. Do they want to have COVID-19 patients tested in their offices?
  • Limitations in the study include its retrospective design and the single center.
  • The complete article can be found here.
  • Look for the Coronavirus Symptoms infographic (available in English and Spanish) under the Patient Information section of the AAAAI COVID-19 resources page, which compares and contrasts symptoms of COVID-19 versus influenza.

Young Children Can Transmit SARS-CoV-2 to Family Members

  • In the September 11 issue of the Morbidity and Mortality Weekly Report (MMWR), the Centers for Disease Control and Prevention (CDC) reports on the Transmission Dynamics of COVID-19 Outbreaks Associated with Childcare Facilities – Salt Lake City, Utah, April- July 2020.
  • This study looked at COVID-19 outbreaks associated with three childcare facilities based on contact tracing. Twelve children acquired COVID-19 in childcare facilities. Transmission was documented from these children to at least 12 (26%) of 46 nonfacility contacts. One parent was hospitalized.
  • Three of the 12 children were asymptomatic. Transmission was observed from two of these three children.
  • The youngest child to transmit the virus was eight months old, had only mild symptoms and infected both parents.
  • None of the facilities required masks for children, and the largest outbreak occurred in a facility where masks were not required for staff or children.
  • The index patients were typically staff members, who contracted the virus outside of the facility, but 54% of the cases occurred in children.
  • Cases and transmission were probably underestimated since testing criteria initially only included staff or children with fever, cough or shortness of breath.

Upcoming CDC COCA Call

  • A Clinician Outreach and Communication Activity (COCA) call on Testing and Treatment of 2020-2021 Seasonal Influenza During the COVID-19 Pandemic will take place on Thursday, September 17 at 2:00 pm EDT.
  • CME credit is available.
  • Information on signing on is available here. If unable to attend, you can access the webinar at the same website address beginning a few hours after the call.

Another Reason for Masks

  • In a Perspective article published online in The New England Journal of Medicine on September 8, the authors from the University of California, San Francisco note epidemiologic evidence suggesting that the rate of asymptomatic COVID-19 patients in areas of universal masking is 80-95%, perhaps related to the effect of universal masking on reducing the viral load upon exposure to COVID-19 for the mask wearer, suggesting viral load influences the severity of the disease.
  • The article can be found here.

CDC Updates Guidance on Antigen Testing for SARS-CoV-2

  • The interim guidance was updated on September 4, and can be found here.
  • It includes good discussion on testing overall, with specifics related to antigen testing performance and interpretation.

Ensuring Telehealth Expansion Act

  • Texas Congressman Roger Williams has introduced a bill (H.R. 8156) to extend telehealth provisions in the CARES Act through December 31, 2025.

Vaccine News

  • From the American Medical Association (AMA) Morning Rounds on September 14: Oxford and AstraZeneca restart their COVID-19 vaccine trial after a halt due to a case of transverse myelitis in one study participant. Pfizer and BioNTech have also asked the Food and Drug Administration (FDA) to expand their COVID-19 vaccine trial to 44,000 volunteers to increase the diversity of the participants. The initial goal of 30,000 participants is expected to be reached by next week.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


September 8, 2020

Here are today's important updates:

AAAAI Statement on Asthma and COVID-19

  • There continues to be mixed messaging about asthma and COVID-19 severity risk. An updated Centers for Disease Control and Prevention (CDC) webpage from last week still states that moderate or severe asthma may be a risk for more severe disease.
  • The majority of studies published in the peer-reviewed literature do not support this statement, and most indicate that asthma is NOT a risk factor.
  • A summary of the literature to date with a bibliography has been posted on the COVID-19 Resource page here. Review this before all the phone calls start.

CDC Offers New Webpage on Masks

  • This new webpage offers advice in cartoon/poster format on how to select, wear and clean your mask. This could be posted in the allergist’s office, on their website or offered as a handout to patients.
  • The webpage can be found here.

CDC Clarifies Its New Testing Guidelines

  • From The Hill publication: “The director of the Centers for Disease Control and Prevention (CDC) on Thursday issued a clarification of earlier guidance on coronavirus testing, days after a quiet change sparked protests from the scientific and medical communities. In a statement, Director Robert Redfield said those who come into contact with confirmed or probable COVID-19 patients could be tested themselves, even if they do not show symptoms of the virus. “Testing is meant to drive actions and achieve specific public health objectives. Everyone who needs a COVID-19 test, can get a test. Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action,” Redfield said.”

More About COVID-19 and Children

  • In a study published online in JAMA Pediatrics on August 28, Han et al looked at a case series of 91 children with COVID-19 in Korea, 22.0% of which were asymptomatic. Only 8.5% of symptomatic cases were diagnosed at the time of symptom onset, while 66.2% had unrecognized symptoms before diagnosis and 25.4% developed symptoms after diagnosis. SARS-CoV-2 RNA was detected for a mean of 17.6 days overall and 14.1 days in asymptomatic cases. The authors conclusions: symptom screening fails to identify most COVID-19 cases in children, and SARS-CoV-2 RNA in children is detected for an unexpectedly long time.
  • As pointed out in the accompanying editorial, “the authors estimate that 85 infected children (93%) would have been missed using a testing strategy focused on testing of symptomatic patients alone."

Salivary Detection of COVID-19

  • You may have read reports in the press concerning salivary testing for COVID-19. Here are two recent studies on the sensitivity compared to nasopharyngeal swabs.
  • In a letter published in Annals of Internal Medicine on August 28, 2020, the authors reported on 1,939 paired swab and saliva samples in a prospectively enrolled cohort of asymptomatic, high-risk persons (not otherwise defined) and those with mild symptoms suggestive of COVID-19. Testing was performed at a centralized testing center. SARS-CoV2 E gene was detected in 70 samples, 80% with swabs and 68.6% with saliva samples. The results were concordant (both positive) in only 48.6%. 31.4% tested positive with swab alone and 20% tested positive with saliva alone. Most of the swabs were oropharyngeal.
  • In a letter published in The New England Journal of Medicine on the same day, authors reported on 70 inpatients with confirmed COVID-19 who were tested using standard NP swabs and saliva samples at the same time point during their hospitalization. Saliva samples were positive to SARS-CoV2 RNA more often than NP swabs, and were more likely to be positive for up to 10 days after diagnosis compared to swabs. They also performed testing in 495 asymptomatic health care workers using simultaneous NP swabs and salivary samples. Saliva samples were positive in 13, nine of whom also did simultaneous NP swabs. Seven of the nine NP swabs were negative. Diagnosis in all 13 was later confirmed by additional NP swabs taken by a CLIA-certified lab (earlier NP swabs were self-performed).
  • All of our discussions about testing are hampered by the lack of a gold standard test for SARS-CoV2, with frequent false negative tests on RT/PCR related to variations in sampling and timing of the tests. There is also recent conversation about RT/PCR tests being too sensitive if the cycle threshold is too high. All of this makes interpretation of these results challenging, but salivary samples may be sensitive enough in the majority of cases for allergists to perform in the office, or before office visits without placing staff at risk. This may allow for more procedures to be performed in our offices.

Seroprevalence of SARS-CoV2 Among Healthcare Personnel

  • Reported in the Morbidity and Mortality Weekly Report on September 4, serological testing was performed in 3,248 frontline healthcare personnel who cared for COVID-19 patients in 13 geographically distinct academic medical centers from April-June. Of those, 6% had evidence for previous infection, and 29% of these were asymptomatic in the previous months and 69% had not received a diagnosis of COVID-19. Prevalence of antibodies was lower in those who wore a face covering (6%) compared to those who did not (9%).

HHS Again Updates Provider Relief Fund FAQs And Extends Deadline

  • The eligibility criteria response was updated on September 1. Application deadline for Phase 2 distribution is September 13.
  • A health care provider may enter the Provider Relief Fund Application and Attestation Portal and enter their TIN for validation and submit a new application for Phase 2 even if there is an application still under consideration as part of Phase 1 of the General Distribution. Please note that Phase 2 applications will not be considered until all applications submitted for a Phase 1 – General Distribution payment have been adjudicated, either by receiving an additional payment or being determined ineligible for a Phase 1 payment. The payment amount received under Phase 2 will reflect total payments received under Phase 1 General Distribution (Added 8/27/20)

NIH Announces Support For Testing

  • On September 2, the NIH announced the award of contracts with nine companies (part of the Rapid Acceleration of Diagnostics (RADx) Initiative) for technologies that include point-of-care tests and high-throughput laboratories than can return results within 24 hours. These awards are in addition to contracts awarded to seven companies in June.
  • Novel technologies in development include a portable, battery-powered RT-PCR device that gives accurate results in 15 minutes, and a portable mini-lab with reagent flexibility that can perform RT-PCR assays in community hospitals and clinics in underserved, rural populations. Additional technologies include a lateral-flow immunoassay test strip that can be read without specialized equipment (similar to home pregnancy tests) and a sample concentrating method that significantly improves the sensitivity and performance of many different types of tests.
  • Details are available here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


August 31, 2020

AAAAI members should be aware that the Centers for Disease Control and Prevention and the National Institutes of Health commissioned a study to be done by the National Academies of Science, Engineering and Medicine to develop a Framework for Equitable Allocation of COVID-19 Vaccine.

It is unlikely that enough vaccine will be available initially to immunize everyone, so this is an attempt to develop criteria for allocation based on most need. The study will recommend priorities to inform allocation of a limited initial supply of COVID-19 vaccine, taking into account factors such as racial/ethnic inequities and groups at higher risk due to health status, occupation, or living conditions.

A Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine will be available for download at this link beginning at 12:00 pm ET on September 1, and two opportunities are being provided to offer comments.

There will be a public listening session on September 2 from 12:00 to 5:00 pm ET, where comments can be made. Registration for the public listening session is now open, and members of the public can sign up to speak. However, please note that due to time constraints, the opportunity to make oral comments is not guaranteed.

Since it is not guaranteed that everyone who signs up will have the opportunity to make a comment during the public listening session, there will also be a written comment period on this discussion draft. It will be open from September 1-4.

Read More Information

Continue to check the AAAAI COVID-19 advocacy page, and refresh your browser to update the links each time. Also, our COVID-19 resources page is frequently updated with the latest useful information, patient resources, and more.


Wednesday, August 26, 2020

Here are today's important updates:

Updates on SARS-CoV-2 Treatment

Allergists are not usually involved in the treatment of patients with COVID-19, but you might like to be updated on the latest headlines and research.

  • Plasma treatment: Data from the largest study to date were “insufficient to justify approval” according to leadership from the National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases. While mortality in hospitalized patients was lowered when given within three days of diagnosis, it is not clear that such early treatment is realistic, plus there was no placebo group. The published results of the study have yet to be peer reviewed. The story can be found here.
  • Although remdesivir has been noted to reduce the duration of hospitalization in severe COVID-19, a study looked at its use in moderate disease. In this randomized, open-label phase three trial that included 584 patients, where remdesivir for five or 10 days was compared to standard care alone, "...those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance." The study can be found here.
  • The NIH has a continuously updated link on treatment guidelines that can be found here.

SARS-CoV-2 Transmission

  • Breast milk: A recent study in The Journal of the American Medical Association (JAMA) involving 18 U.S. women with symptomatic COVID-19 suggests that breast milk may not be a source of infection for the infant. The study was small, with only 64 breast milk samples tested. The article can be found here.
  • Back-to school guidance: The American Academy of Pediatrics has updated its guidance and now says that cloth face coverings should be required for all children over 2-years-old in school settings. Previous guidance suggested that masking of the youngest may not be practical. The updated guidance can be found here.
  • Child care programs: A Morbidity and Mortality Weekly Report from August 21, which was a study of 666 child care programs in Rhode Island from June 1-July 31, indicated that it is possible to re-open child care programs with limited secondary transmission when community incidence of COVID-19 is low, and strict policies about adult masking and limited adult and student mixing, case identification, contact tracing and isolation/quarantine of positive cases are adhered to. It should be noted that 75% of the cases related to child care occurred in the last two weeks of July when cases in Rhode Island were increasing.
  • Face shields: A research letter in JAMA noted that transmission of SARS-CoV-2 was reduced when community health workers in India added face shields to masks and other PPE. The study can be found here.

SARS-CoV-2 Testing

The Centers for Disease Control and Prevention updated its Test for Current Infection guidance on August 24.

  • Considerations for who should get tested: people who have symptoms, people who have been exposed to someone with confirmed COVID-19 (within six feet for at least 15 minutes without PPE) and people who have been asked or referred to get testing by their healthcare provider, or local or state health department.
  • “Not everyone needs to be tested. If you do get tested you should self-quarantine/isolate at home pending test results..."

Pediatric SARS-CoV-2

Data from the Mass General Pediatric COVID-19 Biorepository were published online in The Journal of Pediatrics on August 19. This includes 49 children, from less than 1-years-old to 22-years-old with acute SARS-CoV-2 infection (majority were 5 to 22-years-old, although two-thirds were 5 to 15-years-old).

  • Presenting symptoms were non-specific, only 51% had fever. Nasopharyngeal viral load was highest in the first two days of symptoms and was significantly higher than hospitalized adults with severe disease. Age did not impact viral load.
  • ACE2 receptor gene expression was higher in infected children compared to uninfected, but within the infected cohort, ACE2 expression did not correlate with viral load. Children less than 10-years-old had lower ACE2 expression than those who were over 10-years-old.
  • Incidence of asthma was lower (12.2%) in those with SARS-CoV-2 infection than those without (20.8%). High prevalence was most likely due to the population selected for respiratory illness.

CMS Announces Relief From 2020 MIPS Due to COVID-19

  • The Centers for Medicare and Medicaid Services (CMS) announced that physicians will have the option to opt-out completely or partially from the 2020 MIPS program by completing a hardship exemption application and indicating it is due to the COVID-19 public health emergencyThe application deadline is December 31. This was done automatically for 2019, but clinicians need to apply for the exemption for 2020.

Ultraviolet Lights and Lamps: UVC Radiation, Disinfection and Coronavirus

SARS-CoV-2 Vaccines

  • There was a very interesting interview with Paul A. Offit, MD, of the Children's Hospital of Philadelphia in JAMA Online First from August 24. Access it here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Thursday, August 20, 2020

Here are today's important updates:

Certain Children's Hospitals to Begin Receiving Relief Funds

  • Perhaps of interest to our members who work in Children’s Hospitals, the Department of Health and Human Services (HHS) has announced the distribution of $1.4 billion of monies appropriated through the CARES Act and Paycheck Protection Program.
  • Qualifying hospitals are free-standing Children’s Hospitals that are either an exempt hospital under the Centers for Medicare and Medicaid Services Inpatient Prospective Payment System or a Health Resources and Services Administration defined Children’s Hospital Graduate Medical Education facility.
  • For updates and to learn more, go here.

HHS Provider Relief Fund Phase 2 General Distribution

  • As announced in previous messages, applications for this second distribution are currently available on the Provider Relief portal, and the deadline for applications is August 28.
  • Eligible providers must have billed Medicaid/CHIP programs during the period of January 2018 through December 2019 OR must have billed Medicare during 2019, AND provided patient care after January 31, 2020.
  • Clinicians who received funds from the Phase 1 distribution can still apply if the funds they received were less than 2% of annual revenue. You can also apply if you didn’t receive any Phase 1 funds or rejected/did not accept Phase 1 funds.

FDA Publishes Device Shortage List

  • The CARES Act provided the Food and Drug Administration (FDA) with the authority to monitor, help prevent and help mitigate device shortages during a public health emergency. This authority requires the FDA to keep a publicly available, up-to-date list of devices (including PPE) that the FDA has determined to be in shortage.
  • The information and list can be found here.

FDA Discusses Rapid Testing

  • In its updated FAQs on testing, the FDA pointed out that testing of asymptomatic individuals should be done using the more sensitive RT/PCR testing with nasopharyngeal swabs. Currently antigen tests are only indicated for screening of symptomatic patients, all other scenarios are considered “off label.”
  • Rapid turnaround, point-of-care tests are less sensitive, so negative results should be considered presumptive, and serial testing or sending the sample or a new sample for the standard RT/PCR should be done.
  • The FAQs about testing can be found here.
  • On the other hand, the American Medical Association just released guidance documents for physicians and the general public to limit RT/PCR testing to those with a medical need (those exhibiting symptoms, those requiring a negative test to pursue medical treatment/procedures or healthcare workers). At-home quarantine is recommended as an alternative for those not at an immediate risk of illness or other medically indicated need.
  • And the Centers for Disease Control and Prevention (CDC) also just released interim guidance for antigen testing for SARS-CoV-2 with a good discussion on the uses and limitations of the tests. The details can be found here.

CDC Releases Media Statement Announcing That Updated Isolation Guidance Does Not Imply Immunity

  • This statement was released on August 14 to correct media reports about immunity to reinfection with SARS-CoV-2 in the three months following infection.
  • On August 3, the CDC updated its isolation guidance based on the latest science that people can continue to test positive for up to three months after diagnosis and not be infectious to others. This does not imply that a person is immune to reinfection.
  • This latest data means that retesting is not helpful unless the patient is exhibiting symptoms which cannot be attributed to another illness.
  • More information can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, August 11, 2020

Help in Evaluation of COVID-19 Data

  • Although allergists aren’t usually involved in public policy or recommendations to agencies related to COVID-19, we often are asked to interpret the data for our patients and to make decisions about our employees or practices relative to community transmission.
  • This 11-page publication from the Societal Experts Action Network, an activity of the National Academies of Sciences, Engineering and Medicine, can help us understand the limitations of the various data types reported for COVID-19, and the best ones to use.
  • The PDF can be downloaded for free from this website.

President Issues Executive Order on Telehealth

  • You may have heard the news, but here are some details that apply to allergists, although most of the order is directed at rural healthcare.
  • The order instructs the Secretaries of the Department of Health and Human Services (HHS) and Agriculture to develop and implement a strategy to improve the physical and communications healthcare infrastructure available to rural Americans. This is subject to applicable laws and availability of appropriations. This would help us communicate with our rural patients, since recent information related to remote learning for schools indicate that up to 30% of rural America lacks the bandwidth to participate.
  • The order also instructs the Secretary of HHS, within 60 days, to review the temporary measures related to telehealth services to Medicare beneficiaries and propose a regulation to extend them beyond the duration of the public health emergency, and some of the temporary measures require a legislative fix.
  • This order does not apply to Medicaid extension of telehealth, which depends on the states. The AAAAI has advocated for you to the states to consider similar extensions for Medicaid patients.

HHS Provider Relief Fund FAQs Updates

  • Don't forget that the HHS Provider Relief Fund Phase 2 General Distribution is now accepting additional applicants, after HHS had announced that certain Medicare providers would be given another opportunity to receive additional Provider Relief Fund payments. More details can be found here. These eligible providers may now submit their application for possible funds by August 28, 2020.
  • There are several updates to the FAQs, but here are the important ones that impact most allergists:

Is there a set period of time in which providers must use the funds to cover allowable expense or lost revenues attributable to COVID-19? (Modified 7/30/2020)

As explained in the notice of reporting requirements on the Provider Relief Fund website, reports on the use of Provider Relief Fund money must be submitted no later than July 31, 2021, and accordingly HHS expects that providers will fully expend their payments by that date. HHS will provide directions in the future about how to return unused funds. HHS reserves the right to audit Provider Relief Fund recipients in the future and collect any Relief Fund amounts that were used inappropriately. All payment recipients must attest to the Terms and Conditions, which require the submission of documentation to substantiate that these funds were used for increased healthcare related expenses or lost revenue attributable to coronavirus.

Are Provider Relief Fund payments to commercial (for-profit) organizations subject to Single Audit in conformance with the requirements under 45 CFR 75 Subpart F? (Modified 7/30/2020)

Commercial organizations that receive $750,000 or more in annual awards have two options under 45 CFR 75.216(d) and 75.501(i): 1) a financial related audit of the award or awards conducted in accordance with Government Auditing Standards; or 2) an audit in conformance with the requirements of 45 CFR 75 Subpart F. Audit reports of commercial organizations must be submitted directly to the U.S. Department of Health and Human Services, Audit Resolution Division at AuditResolution@hhs.gov.

CMS Updates FAQs on Medicare FFS Billing

  • There have been several updates to the FAQs since mid-July, which includes questions about subsequent E/M billing for visits after assessment and collection of COVID-19 specimen for a new patient (page 10), and how the CS modifier should be applied to telehealth services and/or E/M visits (page 69).

AMA Starts #MaskUp Campaign

  • In an effort to increase the use of masks among the U.S. population, the American Medical Association (AMA) has started the #MaskUp campaign with a toolkit that contains a variety of social media posts/videos that emphasize the importance of mask use. These can be used by your practices to encourage your patients to wear a mask. The toolkit can be found here.

Hospitalization Rates and Characteristics of Children Hospitalized With COVID-19

  • As our patients potentially head back to school in the next month, allergists need to be aware of the data related to children and COVID-19, since their parents are getting mixed messages from several sources.
  • The August 7 edition of the Morbidity and Mortality Weekly Report (MMWR) presents the results of rates and characteristics of hospitalized patients <18 years of age from COVID-NET, which is a surveillance for confirmed COVID-19 cases in 99 counties in 14 states.
  • From March 1 to July 25, 576 hospitalized children were reported to COVID-NET. The median age was 8 years old, infants <3 months accounted for 18.8%. Of all the children, Hispanics (45.8%) and Blacks (29.7%) accounted for the majority of admissions. The cumulative rate was 8.0 per 100,000 (adults are 164.5 per 100,000) and was highest among children <2 years old (24.8) followed by 5-17 years old (6.4) and 2-4 years old (4.2).
  • 42.3% had an underlying medical condition: obesity in 37.8% (children over age 2), chronic lung disease in 18%, and prematurity 15.4% (children <2 years).
  • 33% were admitted to the ICU (about double the estimates for children with influenza), 5.8% were intubated, and one child died.
  • 10.8% of 83 children for whom information was received were diagnosed with MIS-C.
  • The MMWR can be accessed here

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, August 3, 2020

AAMC Issues Roadmap for COVID-19

  • The Association of American Medical Colleges (AAMC) has issued The Way Forward on COVID-19. “This plan focuses on a set of immediate, evidence-based, commonsense actions the AAMC believes is essential to contain the virus and end the pandemic by addressing critical shortages, improving and broadening testing, reducing the virus’s spread, reopening schools safely, expanding health insurance coverage, and prioritizing distribution of the vaccine. It also identifies longer-term actions that must be taken to protect and strengthen public health, reduce health disparities, and improve the overall health of our nation and its people.”

HHS Report on Expanding Telehealth Favorable

  • The Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) issued a brief on telehealth on July 28, which stated: “The report concludes there is evidence that Medicare’s new telehealth flexibilities played a critical role in helping to maintain access to primary health care services – when many beneficiaries and providers were concerned with transmission of COVID-19. Future research could examine whether these flexibilities were effective and if telehealth may have improved access to care and health outcomes among underserved beneficiaries.” The brief can be found here.

Cigna Announces Extension of COVID-19 Coverage 

  • Cigna announced on July 29 that their virtual care and eConsult guidelines are extended until December 31, 2020. Cigna will allow providers to bill a standard face-to-face visit for all virtual care services, including those not related to COVID-19, through December 31, 2020. Read more.

Reimbursement for Counseling About Self-Isolation at the Time of COVID-19 Testing

  • The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have announced provider reimbursement is available for counseling patients to self-isolate at the time of COVID-19 testing.
  • These counseling services are covered by Medicare. Physicians and other practitioners furnishing counseling services to people with Original Medicare should use existing and applicable coding and payment policies to report services, including evaluation and management visits.
  • Further details can be found on pages 7-9 of this resource.

CDC COCA Call on August 4

  • The CDC holds regular Clinician Outreach and Communication Activity (COCA) calls that are available to all clinicians on a variety of topics. Most are related to COVID-19 or aspects of care related to the public health emergency (PHE).
  • On August 4 from 2:00 to 3:30 pm ET, the call will cover COVID-19 & Telehealth Implementation: Stories from the Field.
  • These calls are recorded and will be available starting a few hours after the call. Free CE is offered for this call and advanced registration is not required.
  • Connection information is available on the CDC COCA Call webpage.

Congressional Activity to Expand and Extend Telehealth

  • There are now three bills in Congress to make the changes, expansions and flexibilities established during the PHE permanent. The COVID-19 HEALS Act provides telehealth access to part time and hourly employees and extends the telehealth flexibilities through the end of the PHE or through 2021, the CONNECT for Health Act explores ways to expand telehealth and begins to permanently remove some of the restrictions, and the Telehealth Modernization Act would make permanent in-home visits and rural telehealth access and make permanent other current temporary changes.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, July 28, 2020

Here are today's important updates:

HHS Telemedicine Hack Series

  • HHS Telemedicine Hack is a 10-week virtual, peer-to-peer learning community to accelerate telemedicine implementation for ambulatory providers. Components of Telemedicine Hack include: Five teleECHO sessions; five virtual “office hour” discussion panels; and inter-session peer-to-peer learning facilitated via virtual discussion boards. CME/CEU credits are available at no cost to participants.
  • Telemedicine Hack sessions take place on Wednesdays from July 22 to September 23, 2020, at 12:00 to 1:00 pm ET.
  • You can still sign up for individual sessions here.

Possible ACP Bulk Buying Program Pending AAAAI Member Interest

  • The American College of Physicians (ACP) is offering a collaborative PPE buying opportunity to medical specialty societies. The AAAAI would like to know how many RSL societies would be interested in participating.
  • The AAAAI would need to commit to making a bulk purchase so there would be some financial risk to the organization. The price break for PPE items would be dependent on how many members participated in the program. The society decides what PPE items to offer to their members and promotes the sale over a one week period (probably August 24-31). A verified members link from the society website to Project N95 (an independent entity) takes orders, purchases the PPE from suppliers, and fulfills and ships orders. The AAAAI needs to commit by the end of the week if we would be interested in participating. Let your RSL Governor know if you are interested.

Guidance for Asthma and Food Allergic Children in School Will Be Coming

  • The AAAAI Office of School-based Management of Asthma, the AAAAI Asthma, Cough, Diagnosis and Treatment Committee, and the National Association of School Nurses are working on a pragmatic approach for treatment of asthma and prevention of food allergy reactions in schools this fall. Look for this to come out in August.

FDA Announces Additional Hand Sanitizer Recalls

  • There are now 77 different hand sanitizer products on the Food and Drug Administration (FDA) recall list, all manufactured in Mexico. The list can be found here.

Senate GOP Stimulus Plan Highlights

  • Senate Majority Leader Mitch McConnell and his Republican colleagues released a series of bills on Monday which constitute the initial drafts of the Senate Republican COVID relief package.
  • American Workers, Families, and Employers Assistance Act: Portions that are important to our membership include the extension of federal unemployment compensation at $200/week until October 5, 2020, and after that an amount equal to 70% of average weekly wages minus base amount which is defined in the bill, until November 30, 2020, (base amount is determined by a somewhat complicated formula) but return to work rules will apply. Also included are grants to states for certain increased expenditures; a stimulus payment in the form of a tax refund of $1,200 ($2,400 for joint filers) and $500 for each dependent, with adjustments for high incomes; enhanced employee hiring and retention payroll tax credit which increases the previous payroll tax credit to 65% from 50% (with limits and modifications to the definition of an eligible employer); employment tax credits for PPE; workplace reconfigurations and technology expenses; and an extension of telehealth waivers and policies to the end of 2021 (although the Secretary is not required to extend a specific waiver or policy if not appropriate for extension) subject to Medicare Payment Commission (MedPac) evaluation and analysis. The bill can be found here.
  • Paycheck Protection Program (PPP): Continuing Small Business Recovery and Paycheck Protection Program Act, which has four main components: SBA 7(a) loans to Recovery Sector Businesses, PPP second draw loans, PPP improvements, and Small Business Growth and Domestic Production Investment Facility. Details can be found here.
  • Liability reforms: The SAFE TO WORK Act.
  • The Safely Back to School and Back to Work Act includes improving earlier access to diagnostic tests, sustained on-shore manufacturing capacity for public health emergencies, improving and sustaining state stockpiles and strengthening the Strategic National Stockpile, modernizing infectious disease data collection, Centers for Public Health Preparedness, telehealth benefits for employees, protection of human genetic information, back to work child care grants, and several other education provisions. For details, go here.
  • An appropriations package, including an additional $5.3 billion for the Defense Production Act, $25 billion for the CARES Act Provider Relief Fund, $3.4 billion for the Centers for Disease Control and Prevention (CDC), $15.5 billion for the National Institutes of Health (NIH), $16 billion for testing and contact tracing, etc.
  • There is much negotiation that still needs to take place with the Democrats, so many of these items may change.

NIH Leaderhip Details Unprecedented Initiative to Ramp Up Testing for COVID-19

  • In this article published in the New England Journal of Medicine, scientific leaders from the NIH set forth a framework to increase significantly the number, quality and type of daily tests for detecting SARS-CoV-2, the virus that causes COVID-19, and help reduce inequities for underserved populations that have been disproportionally affected by the disease.
  • The Rapid Acceleration of Diagnostics (RADx) program was established to fill the need for the nationwide deployment of low complexity, point of care molecular diagnostics with rapid results.
  • RADx includes four major components to enable approximately 6 million daily tests in the United States by December 2020: RADx-tech aims to identify, accelerate development, scale up and deploy innovative point-of-care technologies throughout the fall of 2020; RADx Advanced Technology Platforms (RADx-ATP) will support the scale-up of more advanced technologies that can achieve immediate, substantial increases in capacity; RADx Radical (RADx-rad) will focus on truly non-traditional approaches for testing that have a slightly longer horizon; and RADx Underserved Populations (RADx-UP) will establish community-engaged implementation projects to improve access to testing in underserved and vulnerable populations.

Executive Order Related to Epinephrine Auto-Injector Pricing

  • One of President Trump’s recent Executive Orders stated that injectable epinephrine would be available to patients at 340B pricing. This order only applied to Federally Qualified Health Centers (FQHCs) who are 340B providers.
  • According to health lawyers, this will not significantly impact the price for the majority of our patients. FQHCs already sell drugs at a discount to patients and there is some doubt whether the Executive Order will change much of that, according to an article in Bloomberg News.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, July 24, 2020

Here are today's important updates:

HHS Extends the Public Health Emergency

  • On July 23, Department of Health and Human Services (HHS) Secretary Alex Azar extended the public health emergency, which was due to expire July 25, for another 90 days.
  • This means that all the waivers, rules and regulatory flexibilities that have been in place will continue.

More Vaccine News

  • The Adenovirus vector COVID-19 vaccine being developed by Oxford University and AstraZeneca demonstrated the ability to generate both T cell and antibody responses against SARS-CoV-2 in a study of over 500 adults. The results of this phase 1/2 study were published in The Lancet.

Updated CDC Guidance: When You Can Be Around Others After You Had or Likely Had COVID-19

  • This guidance was updated on July 16.
  • If a person thinks or knows they had COVID-19, and had symptoms, they can be around others after at least 10 days after symptoms first appeared, and at least 24 hours with no fever without fever-reducing medications, and symptoms have improved.
  • If asymptomatic and testing positive, 10 days must have passed since the test, and repeat testing depends on the availability of testing.
  • If you have been around someone with COVID-19, stay home for 14 days after exposure.
  • If you develop symptoms after testing, or after exposure, then follow the first recommendation listed.
  • For healthcare personnel (HCP), a test-based strategy is no longer recommended. If HCP have severe to critical illness or are severely immunocompromised, the recommended duration for work exclusion has been extended to 20 days after symptom onset (or for asymptomatic severely immunocompromised HCP, 20 days after initial positive test). However, because the majority of severely or critically ill patients no longer appear to be infectious 10 to 15 days after onset of symptoms, facilities operating under critical staffing shortages might choose to allow HCP to return to work after 10 to 15 days, instead of 20 days.
  • For HCP without severe disease or who are not severely immunocompromised, use the first criteria noted above.
  • The rationale behind these changes can be found here.

New Updates to HHS Provider Relief Fund FAQs Added on July 17

  • The following is from Hart Health: Not only has HHS updated its Provider Relief Fund FAQs, but HHS has also released additional information on the reporting requirements. According to the reporting requirements document, “[t]he reporting system will become available to recipients for reporting on October 1, 2020.” And “[d]etailed PRF reporting instructions and a data collection template with the necessary data elements will be available through the HRSA website by August 17, 2020.”
  • Updates include new organizations that did not bill Medicare in 2019, Medicaid and CHIP distributions, Enhanced Provider Relief Fund Payment Portal and specific revenue information required.
  • Revenue worksheet can be found here.

Yet Another Hand Sanitizer Recall

  • LIQ-E S.A. de C.V.’s Optimus Instant Hand Sanitizer due to potential presence of methanol. Read more details.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 20, 2020

Here are today's important updates:

Latest Updates From The Provider Relief Funds FAQs

May a health care provider that receives a payment from the Provider Relief Fund exclude this payment from gross income as a qualified disaster relief payment under section 139 of the Internal Revenue Code (Code)? (Added 7/10/2020)
No. A payment to a business, even if the business is a sole proprietorship, does not qualify as a qualified disaster relief payment under section 139. The payment from the Provider Relief Fund is includible in gross income under section 61 of the Code. For more information, visit the Internal Revenue Services' website. (Task Force Note: In our message released on 7/13, we noted that there is bipartisan support in Congress to correct this in the next coronavirus relief bill.)

Is a tax-exempt health care provider subject to tax on a payment it receives from the Provider Relief Fund? (Added 7/10/2020)
Generally, no. A health care provider that is described in section 501© of the Code generally is exempt from federal income taxation under section 501(a). Nonetheless, a payment received by a tax-exempt health care provider from the Provider Relief Fund may be subject to tax under section 511 if the payment reimburses the provider for expenses or lost revenue attributable to an unrelated trade or business as defined in section 513. For more information, visit the Internal Revenue Services' website.

Who is eligible to receive payments from the Provider Relief Fund? (Modified 7/14/2020)
Provider Relief Fund payments are being disbursed via both “General” and “Targeted” Distributions. To be eligible for the General Distribution, a provider must have billed Medicare fee-for-service in 2019, be a known Medicaid and CHIP or dental provider and provide or provided after January 31, 2020 diagnoses, testing, or care for individuals with possible or actual cases of COVID-19, or prevented in the spread of COVID-19. HHS broadly views every patient as a possible case of COVID-19. U.S. healthcare providers may be eligible for payments from future Targeted Distributions. Information on future distributions will be shared when publicly available. All providers retaining funds must sign an attestation and accept the Terms and Conditions associated with payment.

I received an email from the Provider Relief Fund’s DocuSign application web portal informing me that my CARES Act Provider Relief Fund Application DocuSign submission (“envelop”) has expired. Does this mean I am not eligible to receive a General Distribution payment? (Modified 7/14/2020)
No. You received an automated email sent by DocuSign to providers who initiate one or more entries that were not completed or submitted. A number of providers opened duplicate entries in the DocuSign web portal, resulting in one or more of the entries (referred to as “envelopes” by DocuSign) becoming “orphaned” and incomplete. The expiration status of one DocuSign entry does not affect any other submissions by that provider. If an application was completed and submitted, no further action is required on the healthcare provider’s part.

I am a provider using financial statements to complete the application. In Field 10 where it asks for “gross revenue,” should I report net patient revenue, gross patient revenue, or total operating income from the financial statements? (Added 7/14/2020)
The amount reported in Field 10 should be net patient revenue plus other operating income. Net patient revenue is gross patient revenue less contractual adjustments, charity care/financial assistance, and bad debt expense. Other revenues, such as rental income, grants and contributions, joint venture income, and investment income, should be excluded from the amount reported in Field 10.

 

Face Coverings Do Work!

  • In this issue of the Morbidity and Mortality Weekly Report (MMWR), the authors report on a case of two hairstylists who worked for 8 and 5 days respectively with about 139 different clients while symptomatic with COVID-19.
  • Both of the hair stylists and their clients, per salon policy, wore face coverings or masks when working with clients.
  • None of the 139 clients reported symptoms after exposure and 67 were tested and were negative.
  • The index salon worker presumably passed the infection on to her co-worker during periods when they were conversing without masks or face coverings.
  • Both salon workers passed the infection on to family members and/or close contacts outside of work, when not wearing masks or face coverings.
  • Here is a great link to share with your patients about mask effectiveness.
     

Advocacy Opportunity: Protecting Access to Post-COVID-19 Telehealth Act

  • Members of the Congressional Telehealth Caucus have introduced HR 7663, the Protecting Access to Post-COVID-19 Telehealth Act. This bill would eliminate most geographic and originating site restrictions on the use of telehealth in Medicare and establish the patient’s home as an eligible originating site, prevent a sudden loss of telehealth services for Medicare by authorizing CMS to continue reimbursement for 90 days beyond the end of the PHE, make permanent the disaster waiver authority, enabling HHS to expand telehealth in Medicare during all future emergencies and disasters, and require a study on the use of telehealth during COVID-19.
  • Members of the caucus who announced the introduction of the bill include Representatives Mike Thompson (CA-05), Peter Welch (VT-AL), Bill Johnson (OH-06), David Schweikert (AZ-06) and Doris Matsui (CA-06).
  • If one of these caucus members is your representative, contact them and thank them for introducing the bill. If not, then contact your representative and ask them to support the bill.
  • Learn more about advocacy during the Virtual Practice Management webinar this Thursday, July 23.

FDA Announces Additional Hand Sanitizer Recalls

  • 4e Brands North America is recalling several of their hand sanitizer products. All carry the BLUMEN Brand and include Advanced Instant Hand Sanitizer Clear, Advanced Hand Sanitizer, Clear LEAR Advanced Hand Sanitizer, Clear Advanced Hand Sanitizer, and Aloe Advanced Hand Sanitizer with 70 Alcohol.

Vaccine News

CDC Updates Guidance For Healthcare Workers About COVID-19 Testing

  • Updated July 14, this covers testing in healthcare settings, testing in communities, schools and workplaces.
  • Testing in healthcare settings includes testing for healthcare personnel.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 13, 2020

Here are today's important updates:

CDC Announces COVID-19 Social Media Toolkit

  • While not specific for allergists, the Centers for Disease Control and Prevention (CDC) has developed sample messages and graphics related to various COVID-19 topics for Twitter, Facebook and Instagram that we all might find useful for posting on our social media. Access the toolkit.
  • Other useful information from the CDC for posting includes recommendations on summer travel and visiting beaches and pools.

More on Asthma and COVID-19

  • publication in Nature this week showed markedly increased mortality with COVID-19 in those individuals with increasing BMI or non-white ethnicity, and further suggested that asthma patients who had received OCS in the past year also had increased mortality. However, when the data were limited to those in whom BMI, smoking history, and ethnicity were known (and, thus, could be controlled for), asthma with or without OCS use did not demonstrate a significant increased risk for death from COVID-19. Therefore, even with this paper, the preponderance of published data continues to demonstrate no increased severity or mortality with COVID-19 in asthma patients.

Provider Relief Fund FAQ Update

  • New questions and responses were added to the FAQs on July 8. Here are a couple that may be of interest to most:

How can a healthcare provider find more information on the status of their Provider Relief Fund payment or application? (Added 7/8/2020)
Providers should contact the Provider Support Line at (866) 569-3522 (for TTY, dial 711), if they have questions about the status of their payment or application. When calling, providers should have ready the last four digits of the recipient’s or applicant’s Tax Identification Number (TIN), the name of the recipient or applicant as it appears on the most recent tax filing, the mailing address for the recipient or applicant as it appears on the most recent tax filing, and the application number (begins with either “DS” or “CR”) if they have submitted an application in the Provider Relief Fun Payment Portal.

Will healthcare providers that have not had their TINs validated by the application deadline of July 20, 2020, be able to submit an application after that date? (Added 7/8/2020)
Yes. A healthcare provider must submit their TIN for validation by end of day July 20, 2020. If they receive the results of that validation after July 20, they will still be able to complete and submit their application.

COVID-19 Vaccine News

  • The National Institutes of Health (NIH) has launched a clinical trials network to test COVID-19 vaccines and other prevention tools.
  • Established by the National Institute of Allergy and Infectious Diseases (NIAID), the aim is to enroll thousands of volunteers in large scale clinical trials to test a variety of investigational vaccines and monoclonal antibodies. This COVID-19 Prevention Trials Network (COVPN) merges four existing NIAID-funded clinical trial networks, three of which have been doing HIV trials.
  • The vaccine effort will be led by Larry Corey, MD, of the Fred Hutchinson Cancer Research Center in Seattle and Kathleen M. Neuzil, MD, MPD, of the University of Maryland School of Medicine. The monoclonal antibody effort will be led by Myron S. Cohen, MD, of the University of North Carolina, Chapel Hill and David S. Stephens, MD, of Emory.
  • Learn more about this effort at the COVPN’s website. Interested individuals can sign up for a rolling clinical trial participant registry on the website (there are security-enhanced protections).

SARS-CoV-2 Transmission and the Risk of Aerosol Generating Procedures (AGPs)

  • In a Public Health Information Series article from the American Journal of Respiratory and Critical Care Medicine that was published online on June 30, the authors list sputum induction, nebulizer administration, pulmonary function testing and procedures that trigger cough reflex have the potential to generate respiratory aerosols.
  • The authors state that many institutions and professional societies recommend postponing non-urgent AGPs.
  • If AGPs have to be done, optimizing the patient environment (negative pressure rooms) and use of maximal PPE is recommended.
  • This publication reinforces the previous Task Force suggestions that these procedures are and remain high risk for in-office use.

Paycheck Protection Program (PPP) Tax Glitch

  • The American Medical Association (AMA) and others are urging Congress to correct some unintentional tax consequences related to PPP funds received by healthcare providers.
  • Congress specifically exempted PPP funds from taxation, but in drafting the bill, this exemption was not applied to “entities receiving PPP funds from maintaining their tax deductions for expenditures attributable to PPP funds”.
  • Fortunately there is bipartisan support to fix the problem in upcoming legislation.
  • Read more here.

CDC COCA Call This Thursday, July 16

  • CDC’s Clinician Outreach and Communication Activity (COCA) call this week will focus on Clinical Management of Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19.
  • Details are available here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, July 6, 2020

Here are today's important updates:

HHS Will Likely Extend Public Health Emergency

  • HHS spokesperson Michael Caputo tweeted that HHS intends to extend the COVID-19 PHE that is set to expire on July 25 by 90 days. Notable policies affected would include waivers of telehealth restrictions and no cost-sharing for COVID-19 testing.
  • This is only a tweet and a magazine quote, nothing official has been received so far.
     

More Provider Relief Fund FAQ Updates
This list is not inclusive of all updates, but highlights those of interest to the majority of allergists. Latest updates were made on 6/30/20.

Is a healthcare provider eligible to receive a payment from the Provider Relief Fund Medicaid Distribution even if the provider received funding from the Small Business Administration’s (SBA) Payroll Protection Program or the Federal Emergency Management Agency (FEMA)? (Added 6/25/2020)
Yes. Receipt of funds from SBA and FEMA for coronavirus recovery does not preclude a healthcare provider from being eligible for the Medicaid Distribution if the healthcare provider otherwise meets the criteria for eligibility and can substantiate that the Provider Relief Fund payments were used for increased healthcare related expenses or lost revenue attributable to COVID-19, so long as they are not reimbursed from other sources and other sources were not obligated to reimburse them.

What is the difference between the first Provider Relief Fund Payment Portal and the Enhanced Provider Relief Fund Payment Portal for the Medicaid Distribution? (Modified 6/25/2020)
The first Provider Relief Fund Payment Portal was used for providers who received a General Distribution payment prior to Friday, April 24. These providers were required to submit financial information in order to receive approximately 2% of gross revenues derived from patient care.

HHS has developed the new Enhanced Provider Relief Fund Payment Portal for providers who did not receive payments under the previous General Distribution, including those providers who bill Medicaid and CHIP (e.g., pediatricians, long-term care, and behavioral health providers.)

What are the audit requirements that need to be met to comply with Terms and Conditions of the Provider Relief Fund payments? (Added 6/30/2020)
HHS will have significant anti-fraud monitoring of the funds distributed, and the Office of Inspector General will provide oversight as required in the CARES Act to ensure that Federal dollars are used appropriately. HHS will notify recipients of applicable audit requirements in the coming weeks.

PPP Application Extended to August 8

  • There is still $120 billion dollars left in the PPP fund, so if for some reason you didn’t apply during the initial round, you have until August 8 to do so.

Myths and Rumors

  • Misinformation is always present in social media and in conversations among friends. This is even more true when we don’t know everything about a topic, such as COVID-19, although we have certainly learned a lot in the last few months. The CDC now has a webpage called "Stop the Spread of Rumors" that lists known facts about COVID-19. Refer your patients to this page for the most important facts about the disease.

Considerations for Travelers

  • It’s summertime and people are anxious to get out and vacation now that areas are re-opening. We should be encouraging people to remain at home as much as possible and limit non-essential travel, but if your patients are insistent, then refer them to this CDC website for information.

More Telehealth Legislation

  • Representatives Hern (NJ) and Sherrill (OK) have introduced legislation (HR 7391) entitled Protect Telehealth Access Act which would codify Medicare reimbursements for telehealth services including removal of the geographic and location restrictions. Encourage your legislators to co-sponsor if appropriate.

More Hand Sanitizers Containing Methanol

  • The FDA has discovered additional hand sanitizers that contain methanol and are listed at this website. Products include Hand sanitizer Gel Unscented 70% alcohol made by Grupo Insoma S.A.P.I de CV (Mexico); Mystic Shield Protection hand sanitizer, made by Transliquid Technologies (Mexico); Bersih Hand Sanitizer Gel Fragrance Free, and Antiseptic Alcohol 70% Topical Solution hand sanitizer both made by Soluciones Cosmeticas SA de CV (Mexico); and Britz Hand Sanitizer Ethyl Alcohol 70% made by Tropicosmeticos SA de CV (Mexico). Previously we reported on several products made by Eskbiochem SA de CV (Mexico).

American Academy Of Pediatrics (AAP) Releases Guidance for School Re-entry

  • Released on June 29, this guidance does offer some limited discussion on food allergies and treatment of students with asthma and the need for PPE for staff, but is likely to raise some concerns among parents of children with asthma and allergies. We encourage allergists to read it and be familiar with the statements made in the guidance. The guidance can be found here.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, June 26, 2020

Here are today's important updates:

HHS Provider Relief Fund FAQs Update

Additional information has been added to the Department of Health and Human Services (HHS) FAQs on this program. Some items of particular interest:

For how long are the Terms and Conditions of the Provider Relief Fund applicable? (Added 6/19/2020)
All recipients receiving payments under the Provider Relief Fund will be required to comply with the Terms and Conditions. Some Terms and Conditions relate to the provider’s use of the funds, and thus they apply until the provider has exhausted these funds. Other Terms and Conditions apply to a longer time period, for example, regarding maintaining all records pertaining to expenditures under the Provider Relief Fund payment for three years from the date of the final expenditure.

Can a healthcare provider that has not billed Medicaid/CHIP during the eligibility window (January 1, 2018 to December 31, 2019), but is a Medicaid/CHIP enrolled provider, apply for a Medicaid Targeted Distribution payment? (Added 6/19/2020)
Providers who are enrolled in Medicaid and were not eligible for a General Distribution payment may apply for a payment through the Enhanced Provider Relief Fund Payment Portal as long as they provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 after January 31, 2020. HHS broadly views every patient as a possible case of COVID-19. Providers that are not eligible for this distribution may be eligible for future allocations of the Provider Relief Fund.

HHS’ press release indicated that the eligibility timeframe for billing Medicaid or CHIP was January 1, 2018, to May 31, 2020, but the Medicaid/CHIP Provider Relief Fund Payment Forms and Guidance’s instructions indicates the timeframe is January 1, 2018, to December 31, 2019. Are healthcare providers that started billing Medicaid or CHIP in 2020 eligible to apply for these fund? (Added 6/19/2020)
No, new Medicaid or CHIP providers are not eligible to apply yet. Providers who began billing Medicaid/CHIP between January 1 and May 31, 2020 may be eligible for future allocations of the Provider Relief Fund.

HHS collected 2018 and 2019 Medicaid and CHIP provider data from state and federal sources, including corporate names, TINs, and payment amounts, and is using this data to validate Portal submissions. Data is not yet available for new providers who submitted claims between January 1 and May 31, 2020.

Is there a set period of time in which providers must use the funds to cover allowable expense or lost revenues attributable to COVID-19? (Added 6/22/2020)
HHS expects that providers will only use Provider Relief Fund payments for as long as they have eligible expenses or lost revenue. If, at the conclusion of the pandemic, providers have leftover Provider Relief Fund money that they cannot expend on permissible expenses or losses, then they will return this money to HHS. HHS will provide directions in the future about how to return unused funds. HHS reserves the right to audit Provider Relief Fund recipients in the future and collect any Relief Fund amounts that were used inappropriately. All payment recipients must attest to the Terms and Conditions, which require the submission of documentation to substantiate that these funds were used for increased healthcare related expenses or lost revenue attributable to coronavirus.

Telehealth Expansion

  • The AAAAI has been an active co-signer and originator of letters to the Centers for Medicare and Medicaid Services (CMS), HHS and Congress to continue the expansion of telehealth beyond the public health emergency (PHE), and ideally forever. Apparently CMS and HHS do not have the capability of extending these changes beyond the PHE, because it was the PHE that allowed for them. Congress, on the other hand, does have the legislative power to move this forward. On that note, Representative Liz Cheney (R-WY)  has introduced The Advancing Telehealth Beyond COVID-19 Act (H.R. 7338) to permit the Secretary of HHS to waive requirements relating to the provision of telehealth services under Medicare. This bill is co-sponsored by Representatives Greg Gianforte (R-MT), David Kustoff (R-TN) and Jason Smith (R-MO).
  • With passage of this bill, the Secretary would be able to waive the originating site and geographical limitations beyond the PHE period and would make permanent the telehealth coverage at Federally Qualified Health Centers and Rural Health Clinics.
  • The bill has the support of the Connected Health Initiative, a coalition of healthcare systems and industry. Contact your representatives and ask them to co-sponsor this bill.
  • CMS just released the Calendar Year (CY) 2021 Home Health proposed rule, which would update the home health prospective payment system (HH PPS) payment rates and wage index for 2021 and make permanent the changes to the home health regulations regarding the use of technology in providing services, as well as make revisions in response to the COVID-19 PHE interim final rule with a comment period. The rule discusses policies finalized in the CY 2020 HH PPS final rule regarding the permanent home infusion therapy services benefit for CY 2021. Details can be found here. The comment period for this proposed rule is open for 60 days, and the AAAAI and Hart Health will be considering comments.

NIH News

  • Experts identify steps to expand and improve antibody tests in COVID-19 response. More than 300 scientists and clinicians from the federal government, industry and academia published a report of their conclusions and recommendations on COVID-19 serology studies online in Immunity. More information is available here.

FDA Warns About Hand Sanitizers Containing Methanol

  • The Food and Drug Administration (FDA) advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol. Included products are: All Clean, Esk Biochem, CleanCare NoGerm and CleanCare NoGerm Advanced, Lavar 70 Gel, The Good Gel, and Saniderm Advanced. Read the FDA announcement.

More on Asthma and COVID-19

  • A research letter published online in CHEST on June 6 (Lieberman-Cribbin W, Rapp J, Alpert N, Tuminello S, Taioli E, The impact of asthma on mortality in COVID-19 patients, CHEST (2020), doi: https://doi.org/10.1016/j.chest.2020.05.575.) noted that among the 11,405 patients within the Mount Sinai Health System in New York City who had a COVID-19 related hospital encounter, “asthma was not associated with a higher risk of mortality” and the authors noted a low prevalence of asthma in the Mount Sinai Health System COVID-19 registry. Asthma was self-reported in this group.
  • Chhiba et al. (Chhiba KD, Patel GB, Vu THT, Chen MM, Guo A, Kudlaty E, Mai Q, Yeh C, Muhammad LN, Harris KE, Bochner BS, Grammer LC, Greenberger PA, Kalhan R, Kuang FL, Saltoun CA, Schleimer RP, Stevens WW, Peters AT, Prevalence and characterization of asthma in hospitalized and non-hospitalized patients with COVID-19, Journal of Allergy and Clinical Immunology (2020), doi: https://doi.org/10.1016/j.jaci.2020.06.010) in a retrospective study of 1,526 patients with confirmed COIVD-19 infection in the Northwestern University health system, noted a higher prevalence of asthma (14%) in this population, but asthma was not associated with an increased risk of hospitalization (RR of 0.96) after adjusting for age, sex, gender and co-morbidities, regardless of the use of inhaled steroids.
  • Killerby et al. (Killerby ME, Link-Gelles R, Haight SC, et al. Characteristics Associated with Hospitalization Among Patients with COVID-19 — Metropolitan Atlanta, Georgia, March–April 2020. MMWR Morb Mortal Wkly Rep 2020;69:790–794. doi: http://dx.doi.org/10.15585/mmwr.mm6925e1) analyzed data from 220 hospitalized and 311 non-hospitalized COVID-19 adult patients from six metropolitan Atlanta hospitals and associated clinics. Risk factors associated with hospitalization included older age, Black race, lack of insurance, male sex, smoking and obesity. Of note was that chronic respiratory disease was not a risk factor.

New Addition to AAAAI COVID-19 Resources Page

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, June 19, 2020

Here are today's important updates:

Provider Relief Fund Update From Hart Health Strategies
Additional information has been added to the Department of Heath and Human Services (HHS) FAQs on this program. Some items of particular interest:

Who is eligible to receive payments from the Provider Relief Fund? (Modified 6/12/2020)
Provider Relief Fund payments are being disbursed via both “General” and “Targeted” Distributions. To be eligible for the General Distribution, a provider must have billed Medicare fee-for-service in 2019 and provide or provided after January 31, 2020, diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. HHS broadly views every patient as a possible case of COVID-19. $50 billion will be disbursed in the General Distribution. A description of the eligibility for the announced Targeted Distributions can be found here. U.S. healthcare providers may be eligible for payments from future Targeted Distributions. Information on future distributions will be shared when publicly available. All providers retaining funds must sign an attestation and accept the Terms and Conditions associated with payment.

The Terms and Conditions for all Provider Relief Fund payments require recipients who receive at least $150,000 in the aggregate from any statute primarily making appropriations for the coronavirus response to submit quarterly reports to HHS and the Pandemic Response Accountability Committee. This requirement is from section 15011 of the CARES Act. What do providers need to do in order to be in compliance with this provision in the Terms and Conditions? (Added 6/13/2020)
Recipients of Provider Relief Fund payments do not need to submit a separate quarterly report to HHS or the Pandemic Response Accountability Committee. HHS will develop a report containing all information necessary for recipients of Provider Relief Fund payments to comply with this provision. For all providers who attest to receiving a Provider Relief Fund payment and agree to the Terms and Conditions (or retain such a payment for more than 90 days), HHS is posting the names of payment recipients and their payment amounts on its public website. HHS is also working with the Department of Treasury to reflect the aggregate total of each recipient’s attested to Provider Relief Fund payments on usaspending.gov. Posting these data meets the reporting requirements of the CARES Act. However, the Terms and Conditions for all Provider Relief Fund payments also require recipients to submit any reports requested by the Secretary that are necessary to allow HHS to ensure compliance with payment Terms and Conditions. HHS will be requiring recipients to submit future reports relating to the recipient’s use of its PRF money. HHS will notify recipients of the content and due date(s) of such reports in the coming weeks.

Why might a provider that bills Medicare fee-for-service not have received a payment from the initial $30 billion General Distribution? (Added 6/15/2020)
Some providers who did bill Medicare fee-for-service in CY2019 were not eligible for payment because either the provider is terminated from participation in Medicare or precluded from receiving payment through Medicare Advantage or Part D; is currently excluded from participation in Medicare, Medicaid, and other Federal health care programs; or currently has Medicare billing privileges revoked as determined by either the Centers for Medicare & Medicaid Services or the HHS Office of Inspector General.

If the provider’s TIN that was intended for payment identifies both a social security number of an individual Medicare provider and another Medicare provider’s employer identification number, that TIN was excluded from the General Distribution. Providers were also excluded from the General Distribution if there was incomplete banking information and/or personal contact information. HHS is working to determine eligibility for a General Distribution payment for those affected providers.

  • Many of the answers to the previous questions have been modified as of June 12, so be sure and double check questions that you checked prior to this date.

MedPAC Releases June 2020 Report to Congress

  • This report includes seven chapters focused on key issues related to the Medicare program and healthcare delivery. The portion applicable to allergists and a focus of AAAAI advocacy efforts relates to extension of the telehealth modifications arising out of the COVID-19 pandemic. Here is what the Commission had to say: “[p]olicymakers and researchers will need to evaluate the effects of recent legislative and regulatory changes on Medicare spending and outcomes to determine which policy changes are worth keeping in place once the pandemic has ended."

New CDC Guidelines on SARS-CoV-2 Testing

  • Revisions were made on June 13, 2020, to reflect the following: Changes noted were made in a retired document, “Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19),” which has been replaced by this Overview of Testing for SARS-CoV-2.
  • The document covers viral testing, antibody testing, and categories of people for viral testing (PCR): testing individuals with signs or symptoms consistent with COVID-19; testing asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission; testing asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings; testing to determine resolution of infection (i.e., test-based strategy for Discontinuation of Transmission-based Precautions, HCP Return to Work, and Discontinuation of Home Isolation); and public health surveillance for SARS-CoV-2.
  • U.S. testing data was updated on June 12. Total tests reported: 23,290,724 (7% of U.S. population). Total tests positive: 2,469,684 (11%). Percent positive varies by location. Check your location for relevant information.

NIH Announces All of Us Research Program to Seek New Insights into COVID-19

  • The All of Us research program is part of the National Institutes of Health (NIH), and it was announced on June 16 that they would be leveraging their significant and diverse participant base (350,000 participant partners across the United States) to seek new insights into COVID-19—through antibody testing, a survey on the pandemic’s impacts, and collection of electronic health record (EHR) information.
  • Data gathered through these activities will be accessible to approved researchers over time, in future releases of its data platform, the Researcher Workbench, now in beta testing.
  • Antibody testing will be done on 10,000 or more participants starting with samples from March 2020 and working backwards until positive tests are no longer found. Study collaborators include the Frederick National Laboratory for Cancer Research, the National Institute of Allergy and Infectious Diseases, the Centers for Disease Control and Prevention, and Quest Diagnostics.
  • Participants will be asked to complete an online survey on physical and mental health effects of COVID-19 monthly until the pandemic ends.
  • More than 200,000 participants have shared their EHRs so far and the program is collecting relevant information related to COVID-19 symptoms and associated health problems.
  • Read more information here. New participants can still sign up at joinallofus.org.

UnitedHealthcare Extends COVID-19 Temporary Telehealth Expansion and Cost Share Waivers to September 30

  • This applies to Medicare Advantage, individual and fully insured group market health plans and Medicaid.
  • State-specific and Medicaid rules, regulations and limitations may apply.
  • Providers will be reimbursed at parity with in-person visits.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, June 15, 2020

Here are today's important updates:

CMS Announces Possible 2020 MIPS Relief

  • Hart Health Strategies informed the AAAAI that the Centers for Medicare and Medicaid Services (CMS) released a 2020 MIPS Exception Applications Fact Sheet on June 5, which discusses its MIPS Extreme and Uncontrollable Circumstances application-based and automatic exception policies.
  • Individual clinicians, groups, and virtual groups can submit an application to have their 2020 MIPS Quality, Cost, Improvement Activities, and/or Promoting Interoperability performance categories reweighted to 0% if they experience an extreme and uncontrollable circumstance outside of their control, including COVID-19, that prevents them from collecting data for an extended period of time, or that could impact their performance on cost measures. Applications may be submitted now through December 31, 2020.
  • Unlike 2019 MIPS data, where clinicians were automatically reweighted based on COVID-19, CMS has not yet identified any qualifying events that would qualify for automatic exceptions for the 2020 MIPS performance year (so you have to apply).

Considerations for Peanut OIT

  • As with most other procedures we have discussed, the ultimate decision on what to do in your practice is up to you. Given that, here are considerations that you should be aware of. Safety of the patient and staff and level of need related to medical decision making should be the guiding factors for your decision. Safety would involve consideration of the community spread, which determines the risk of a patient having asymptomatic or pre-symptomatic disease, availability of PPE and physical distancing in your office.
  • Based on data from the pivotal trials with Palforzia, the initial dose escalation visit had a low risk for anaphylaxis but the highest time of prolonged contact with staff and room utilization. The updosing visit had the highest risk for a systemic reaction with 3.5% of patients with a mild reaction, 5.1% with a moderate reaction, and 0.6% with a severe reaction. To be fair, the rates of mild and moderate systemic reactions in the placebo group were 1.4% and 2.1%, respectively. Moderate reactions are likely to involve respiratory or moderate GI symptoms, which would result in high risk exposure for staff.
  • Because of the potential for anaphylaxis and respiratory symptoms during these in-office visits, each office should consider the most appropriate form of PPE for staff involved in direct patient care and/or treatment should symptoms occur, including gown, gloves, respirator (N95 or equivalent mask) and eye protection.

From the NIH

  • National Institutes of Health (NIH) researchers have identified key genomic features that could differentiate SARS-CoV-2 from other coronaviruses that cause less severe disease. You can read more here.
  • There are now 365 clinical trials listed at clinicaltrials.gov related to COVID-19. These trials include anti-inflammatory treatments such as TNF inhibitors, kinase inhibitors and IL-6 inhibitors, convalescent plasma, nutritional supplements, and inhaled nitric oxide, to name a few. As we have stated before, at this time there is no evidence for an effective treatment for the virus other than the modest effect of remdesivir in shortening the time to clinical improvement.
  • Vaccines: Previous research on SARS-CoV-1 and MERS has led to more rapid development of potential vaccines against SARS-CoV-2. As part of Operation Warp Speed, the federal government is funding three vaccine candidates for Phase 3 trials this summer: mRNA-1273 developed by National Institute of Allergy and Infectious Diseases (NIAID) scientists and collaborators at Moderna, which directs cells to express a viral protein to elicit an immune response, starting in July; AZD1222, which uses a chimpanzee adenovirus vector to deliver a SARS-CoV-2 protein, being developed by Oxford’s Jenner Institute in partnership with AstraZeneca, starting in August; and BNT162, an mRNA-based vaccine being developed by BioNTech and Pfizer, which will start in September. A nice table and summary can be found in this article.
  • It is always important to remember that some vaccines have caused more harm than good, so safety is as important as effectiveness in the development of vaccines. Safety not only refers to direct adverse effects, but possible enhancement of disease with exposure to the virus. This article by Barney Graham at NIH provides a perspective on this issue.

HHS Medicaid Targeted Distribution

  • As noted in our last message, HHS has set up a new Portal for another $15 billion distribution of Provider Relief Funds to eligible clinicians who have NOT received payment from the $50 billion General Distribution, and must have directly billed Medicaid for healthcare-related services in 2018 or 2019 and provided patient care after January 1, 2020.
  • A section about the Medicaid Targeted Distribution has been added to the CARES Act Provider Relief Fund FAQs.

CDC Social Media Toolkit

  • The Centers for Disease Control and Prevention (CDC) has created a toolkit to help public health officials, health departments, community organizations, healthcare systems and providers to reach populations who may need COVID-19 prevention messaging in their native language.
  • It appears to be only available in Spanish at this time.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, June 9, 2020

Here are today's important updates:

Safe Use of Disinfectants

  • This week's Morbidity and Mortality Weekly Report (MMWR)—Gharpure R, Hunter CM, Schnall AH, et al. Knowledge and Practices Regarding Safe Household Cleaning and Disinfection for COVID-19 Prevention - United States, May 2020. MMWR Morb Mortal Wkly Rep. ePub: 5 June 2020. DOI: http://dx.doi.org/10.15585/mmwr.mm6923e2—describes the results of an opt-in internet survey report that indicated 39% of respondents were using these products in nonrecommended high-risk practices. Those who were using the products in this fashion were more likely to have an adverse health effect, but 25% of the group in general reported effects.
  • We all know that our patients are more sensitive to the effects of household cleaners and disinfectants, and allergists need to remind their patients about protection and proper use of these products in this time of heightened use. Here is a helpful one-page guide from the Environmental Protection Agency.

HHS Issues Amendment to Limit Liability

  • The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (HHS) to provide liability immunity to healthcare providers against claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (except for claims of willful misconduct) against COVID-19 (as amended by the CARES Act).
  • The amendment states that: "Covered countermeasures are 1) any antiviral, any other drug, any biologic, any diagnostic, any other device (authorized for investigational or emergency use), any respiratory protective device (NIOSH approved), or any vaccine used a) to treat, diagnose, cure, prevent, mitigate or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or b) to limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might otherwise cause; or 2) any device used in the administration of any such product, and all components and constituent materials of any such product."

HHS Updates FAQs on Provider Relief Funds on June 8

HHS Announces Enhanced Provider Portal, Relief Fund Payments for Safety Net Hospitals, Medicaid and CHIP Providers

  • On Wednesday, June 10, HHS will be launching an enhanced Provider Relief Fund Portal that will allow eligible Medicaid and CHIP providers to report their annual patient revenue. Payment to each provider will be at least 2% of reported gross revenue from patient care.
  • Eligible providers include clinicians that participate in state Medicaid and CHIP managed care organizations who have not yet received General Distribution funding from the Provider Relief Fund. More information can be found here.

NIH Announces Study That Identifies Potential Approach to Treat Severe Respiratory Distress in COVID-19

  • This is mentioned only because you may hear about it from patients or notice it in the news.
  • In a small, prospective off-label, proof-of-concept study of 19 hospitalized COVID-19 patients with low blood oxygenation and evidence of inflammation, eight of whom had been on ventilators, were treated with acalabrutinib, a BTK-inhibitor. Eight of the 11 patients on supplemental oxygen experienced a substantial drop in inflammation after one to three days and breathing improved. Four of the eight ventilator patients were able to be weaned off the ventilator. There was no comparator group. Results were used to inform the trial design for a randomized, controlled clinical trial in COVID-19 patients.
  • The study was published in the June 5 issue of Science Immunology and is available through open access.

More on Hydroxychloroquine

  • It was announced that studies on hydroxychloroquine in COVID-19 published earlier this year in Lancet and the New England Journal of Medicine (NEJM), both of which showed a lack of effect, were withdrawn due to problems with confirming the accuracy of patient data submitted via a registry.
  • A study was published in The BMJ on May 14 (BMJ 2020;369:m1849) from China on 150 hospitalized COVID-19 patients with mild-moderate disease who were enrolled in a multi-center, open-label randomized control trial of hydroxychloroquine plus standard care vs. standard care alone. The primary outcome measure was negative conversion of SARS-CoV-2 by day 28. There was no difference in conversion in the two groups. Adverse events were higher in the treated group, although only two had serious adverse events.
  • A study published in the NEJM on June 3 looked at the efficacy of hydroxychloroquine in over 800 patients as post-exposure prophylaxis after a high-risk or medium-risk exposure to a confirmed case of COVID-19 and noted no difference in rate of infection between treated and untreated groups.
  • Media headlines will likely grab the attention of our patients and we should be prepared to continue to offer guidance that there remains no evidence to support the use of hydroxychloroquine for prophylaxis or treatment of COVID-19.

Hazards of PPE

  • Prolonged use of PPE and hand hygiene during this pandemic can result in contact allergic/irritant dermatitis, pressure-related skin injury, acneiform eruptions, and moisture-associated skin irritation.
  • This pre-proof article (Desai SR, Kovarik C, Brod B, James W, Fitzgerald ME, Preston A, Hruza GJ, COVID-19 & PPE: Treatment and Prevention of Skin Conditions Related to the Occupational Use of Personal Protective Equipment, Journal of the American Academy of Dermatology (2020), DOI: https://doi.org/10.1016/j.jaad.2020.05.032) offers useful tips on how to deal with them.
  • Information summarized by InYoung Kim, MD, PhD, a reviewer, noted the following: For contact or irritant dermatitis due to masks, the authors recommend using alcohol-free barrier film wipes or thin foam dressings behind the ears and wearing N95 mask straps on the crown of the head to minimize contact with ears. To prevent and treat pressure-related facial skin injury, a thin hydrocolloid or foam dressing can be worn under surgical masks and an alcohol-free barrier wipe can be applied to areas of direct contact prior to wearing N95 masks. For those with skin damage, petroleum jelly (Vaseline) applied three to four times daily or hydrocolloid dressing applied to open wounds is recommended while not at work. To prevent acneiform eruptions and moisture-associated skin irritation, washing with noncomedogenic cleansers before and after work and taking breaks from the mask for 15 minutes every two hours are recommended. To mitigate irritant hand dermatitis and contact sensitization, emollients with either ceramides and/or petrolatum are encouraged, especially after washing hands.

EAACI Statement on Biologics in Times of COVID-19

Review on Prevalence of Asymptomatic SARS-CoV-2 Infection

  • A nice review was published in the Annals of Internal Medicine on June 3.
  • Key takeaway: We still don’t know for sure, but a “patchwork” of studies offer some insights.
  • It may be as high as 40 to 45%, but data has limits.

Now Is a Good Time to Reach Out

  • Several sources have noted a decline in emergency room use and scheduled visits due to patient concerns about risk, as well as a lack of availability for procedures, in-person visits and even telemedicine. Now that practices are resuming, allergists should reach out to their patients with chronic conditions such as severe asthma, food allergies and immune disorders and make sure that they are doing well. You can check and see if they are taking care of any additional chronic conditions as well.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, June 5, 2020

Here are today's important updates:

Great News! Paycheck Protection Program Flexibility Act Is Now Law

  • The Senate on Wednesday passed this act by unanimous consent, and the President signed it on June 5.
  • It was mentioned in earlier messaging, but to summarize the key points again: Borrowers would have 24 weeks instead of eight weeks to use the funds or until December 31, whichever comes sooner, and it lowers the amount they must spend on payroll to qualify for forgiveness to 60% from 75%.
  • More than $120 billion remains available for loans under the Paycheck Protection Program.
  • Some Senators noted that this bill does not allow for proportional forgiveness for payroll amounts less than 60%, but that may be changed with further legislative fixes.

HHS Updates CARES Act Provider Relief Fund FAQs 

  • This page is truly changing daily and you need to check it frequently. The following were added on June 2 and 3.

The Terms and Conditions state that Provider Relief Fund payments will only be used to prevent, prepare for, and respond to coronavirus and shall reimburse the Recipient only for healthcare-related expenses or lost revenues that are attributable to coronavirus. What expenses or lost revenues are considered eligible for reimbursement?

The term “health care related expenses attributable to coronavirus” is a broad term that may cover a range of items and services purchased to prevent, prepare for, and respond to coronavirus, including:

  • supplies used to provide healthcare services for possible or actual COVID-19 patients;
  • equipment used to provide healthcare services for possible or actual COVID-19 patients;
  • workforce training;
  • developing and staffing emergency operation centers;
  • reporting COVID-19 test results to federal, state, or local governments;
  • building or constructing temporary structures to expand capacity for COVID-19 patient care or to provide healthcare services to non-COVID-19 patients in a separate area from where COVID-19 patients are being treated; and
  • acquiring additional resources, including facilities, equipment, supplies, healthcare practices, staffing, and technology to expand or preserve care delivery.

Providers may have incurred eligible health care related expenses attributable to coronavirus prior to the date on which they received their payment. Providers can use their Provider Relief Fund payment for such expenses incurred on any date, so long as those expenses were attributable to coronavirus and were used to prevent, prepare for, and respond to coronavirus. The Department of Health and Human Services (HHS) expects that it would be highly unusual for providers to have incurred eligible expenses prior to January 1, 2020.

The term “lost revenues that are attributable to coronavirus” means any revenue that you as a healthcare provider lost due to coronavirus. This may include revenue losses associated with fewer outpatient visits, canceled elective procedures or services, or increased uncompensated care. Providers can use Provider Relief Fund payments to cover any cost that the lost revenue otherwise would have covered, so long as that cost prevents, prepares for, or responds to coronavirus. Thus, these costs do not need to be specific to providing care for possible or actual coronavirus patients, but the lost revenue that the Provider Relief Fund payment covers must have been lost due to coronavirus. HHS encourages the use of funds to cover lost revenue so that providers can respond to the coronavirus public health emergency by maintaining healthcare delivery capacity, such as using Provider Relief Fund payments to cover:

  • Employee or contractor payroll
  • Employee health insurance
  • Rent or mortgage payments
  • Equipment lease payments
  • Electronic health record licensing fees

All providers receiving Provider Relief Fund payments will be required to comply with the reporting requirements described in the Terms and Conditions and specified in future directions issued by the Secretary. HHS will provide guidance in the future about the type of documentation we expect recipients to submit on the CARES Act Provider Relief page.

  • If you were not able to submit your revenue information by June 3, you will not be considered for a portion of the $20 billion remaining funds.

CMS Summary of Policies in the Calendar Year 2020 Medicare Physician Fee Schedule Public Health Emergency Interim Final Rules

  • The Centers for Medicare and Medicaid Services (CMS) Medicare Learning Network has established a website that summarizes, in one place, the changes made over this public health emergency. It can be found here.
  • Topics include the multiple facets related to telehealth. We advise bookmarking this page for future reference.

House Energy and Commerce and Senate Finance Commitees Query HHS About Support for Medicaid Providers

  • Bipartisan leadership of these committees are concerned about HHS’ timeline to release a dedicated tranche of these funds for Medicaid-dependent practitioners, as well as the level of funding.

CDC Updates FAQs on K-12 Schools and Child Care Centers Relative to Children with Asthma

  • The Centers for Disease Control and Prevention (CDC) has released new FAQs regarding students going to school. In these FAQs it is suggested that peak flow meters could be used, as forceful exhalation “is not considered an aerosol-generating procedure”. The CDC does acknowledge that people with asthma may cough when performing a forceful exhalation. They also reference a meta-analysis (PLoS One. 2012; 7(4): e35797. doi: 10.1371/journal.pone.0035797) that suggests that aerosols generated from nebulizers may not be infectious. The supporting data for this is very poor, however. There were three studies that involved nebulization, all were retrospective. One found the relative risk of infection from SARS-CoV-1 to be 1.11-9.42 for using a nebulizer (Emerg Infect Dis. 2004 Feb; 10(2): 251–255. doi: 10.3201/eid1002.030838). Another reported a patient who infected a group of medical students, with reduced transmission when a nebulized beta-agonist was administered (Emerg Infect Dis. 2004 Feb; 10(2): 269–276. doi: 10.3201/eid1002.030452). The third examined health care workers and found none of nine individuals exposed to a nebulizer developed SARS (PLoS One. 2010; 5(5): e10717. doi: 10.1371/journal.pone.0010717). The CDC recommends wearing a mask, gloves and eye protection when assisting with nebulizer therapy or peak flow meter use, but the COVID-19 Response Task Force does not believe this is sufficient evidence to not wear full PPE (gown, gloves, N95 mask and eye protection) when performing nebulized therapy, and we question the overall safety of peak flow usage in public without wearing gloves, mask and eye coverage as recommended by the CDC.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, June 2, 2020

Here are today's important updates:

HHS Announces Providers Need to Take Action by June 3

  • The Department of Health and Human Services (HHS) has caused some confusion related to the Provider Relief Fund with its 90 day extension announced previously. On the HHS CARES Act Provider Relief Fund website, it now states: Providers need to take action by June 3, 2020. Providers must submit revenue information to the General Distribution Portal by June 3, 2020, to be considered for an additional payment from the Provider Relief Fund $20 billion General Distribution. Once providers submit their revenue information by June 3, 2020, if deemed qualified for additional payment, providers will then have 90 days from receipt of payment of the additional General Distribution funds to agree to the program Terms and Conditions.
  • We realize that some of you may have received an email from HHS informing you of this, but we want to be sure you are aware.
  • HHS has also updated the FAQs on this website effective May 26 and May 29. These updates include answers to questions about actions needed to take after receiving a payment, how to return a payment, what to do if a payment is greater than expected or received in error, the definition of Executive Level II pay ($197,300), how HHS will recoup funds from overpayment or payments in error, and other questions related to additional General Distribution, use relative to Paycheck Protection Program funds, and so on. We encourage you or your business manager to review these FAQs for information relevant to your practice.

CMS Updates FAQs on Medicare FFS Billing

  • View the FAQs.
  • Some changes were made related to Fee-for-Service (FFS) billing, including telehealth, on May 27.
  • Changes in telehealth related to the CARES Act are not included.
  • This is a long document, but most of the FAQs of interest to the practicing allergist start on page 35 and 46.

CMS Issues Final CY Medicare Advantage Part D Changes

  • The Centers for Medicare and Medicaid Services (CMS) has codified existing Part C and D program policies related to network adequacy, which includes encouraging and accounting for certain telehealth providers (i.e., Dermatology, Psychiatry, Cardiology, Otolaryngology, Neurology, Ophthalmology, Allergy and Immunology, Nephrology, Primary Care, OB/GYN, Endocrinology, and Infectious Disease) in Medicare Advantage (MA) plans.
  • Read more in this fact sheet.

CDC Updates Guidance on When You Can be Around Others After You Had or Likely Had COVID-19

CDC Provides New Guidance for Schools and Day Camps, As Well As Households Living in Close Quarters

UnitedHealthcare Announces Updates to Their Telehealth Policies

  • Extends waiver for originating site for MA to September 30. For Medicaid, will follow state regulations, and for commercial insurance to July 24 (end of current public health emergency).
  • For MA plans, reimbursement for telehealth will only apply to audio-video services. Telephone only visits must be billed using telephone codes. For commercial insurance, providers can bill for telehealth services for audio-video or audio only.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 29, 2020

Here are today's important updates:

What's New in Diagnosis and Treatment

  • There is an interesting collaborative study with Adaptive Biotechnologies and Microsoft (ImmuneRACE), which maps the genetic material of all immune receptors in the blood and then uses machine learning to determine those that respond to SARS-CoV-2 in patients with known exposure, current infection or prior infection. This study should enhance our understanding of the specific immune response, and thus enable earlier and more accurate detection of COVID-19.
  • As a reminder, you can get the latest on research on COVID-19 at this page.
  • Information on testing supplies, tests, and Emergency Use Authorizations can be found here.
  • The Centers for Disease Control and Prevention (CDC) has issued new guidance on serologic testing.

Telehealth Parity

  • A major focus of advocacy efforts by the AAAAI, American Medical Association, and other medical societies has been on the extension of parity between in-person visits and telemedicine visits. Research on the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services (HHS) websites indicate that a public health emergency (PHE) declaration is in effect for 90 days after the announcement, unless specifically stated that the PHE is over. The last renewal of the PHE by HHS was on April 20. This would indicate that the PHE, and all the waivers, flexibility, and regulations that were to be in effect as long as the PHE lasts, should continue until at least the third week in July, unless the PHE is declared over. Check your insurer’s website to see if they have also extended their rules with respect to parity for virtual visits. As an example, Cigna changed their website to indicate that they would continue to offer their interim policies concerning virtual care until July 31.
  • In fact, the AAAAI is hosting a Virtual Advocacy Day on Wednesday, June 3, and one of the three priority issues is extending and strengthening access to telehealth beyond the COVID-19 PHE. The other two issues are food allergy research funding, and allergy and asthma management for school-aged children. Watch your email for instructions on how you can participate in AAAAI's June 3 Virtual Advocacy Day, and as always, you can contact advocacy@aaaai.org with any questions.

Another Update from HHS on the Provider Relief Fund

  • On May 22, HHS announced a 45 day extension for providers who are receiving payments from the Provider Relief Fund to accept the terms and conditions. That means that providers have a total of 90 days to respond or return the funds.

Changes Proposed for PPP

  • The House passed the Paycheck Protection Program Flexibility Act sponsored by Representatives Chip Roy (R-TX) and Dean Phillips (D-MN) on Wednesday by a vote of 417-1, which proposes to allow forgiveness for expenses beyond the eight week covered period, remove the 75/25 rule, eliminate the restriction limiting the loan terms of two years, and expand forgiveness for businesses unable to rehire due to the continuing pandemic. This bill would not change the allowable expenses under the current Paycheck Protection Program (PPP). Also under consideration is the TRUTH Act. This legislation would require the Small Business Administration to provide details on loans made over $2 million and justify policy decisions like the recent slashing of Economic Injury Disaster Loan limits, ensuring transparency and accountability from the agency while protecting the privacy of recipients of smaller loans.
  • On a separate front, Representative Abby Finkenauer (R-IA) introduced the Protecting Paychecks and Employees Act, which would allow small businesses to use funds from PPP loans on personal protective equipment (PPE) for their employees. The bill would also eliminate the requirement that small businesses use 75% of loan proceeds on payroll.

FDA Announcement on Policy Changes Regarding Food Labeling

  • Hopefully you read the email blast from AAAAI President Mary Beth Fasano, MD, MSPH, FAAAAI, concerning this announcement from the Food and Drug Administration (FDA), which came out May 26. If not, the FDA established a temporary policy regarding certain food labeling requirements based on requests from the food industry about the need for omissions or substitutions of minor ingredients in the manufacture of some foods, and the inability to make label changes for these substitutions without slowing food distribution. This came about as the result of shortages in some food ingredients.
  • This change has led to several announcements/concerns expressed by food allergy advocates concerning risk to food allergic patients.
  • The allergist should be aware that the FDA policy guidance recommends against substitutions for the eight major food allergens, gluten, sulfites, or "other foods known to cause sensitivities" (sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard). Substitutions will be allowed only for ingredients present at 2% or less, spices, fats and oils, artificial flavors, colors, or acids.
  • The AAAAI has sent a letter to the FDA emphasizing the potential impact of these changes and the need to ensure that the guidance issued is followed for the sake of the food allergic patient.
  • Experts from the AAAAI feel that these changes are not likely to have any significant impact on our food allergic patients, with rare exceptions, and the allergist should be reassuring to their patients and/or parents.
  • Patients that might be impacted could include FPIES infants with severe rice sensitivity or perhaps some EoE patients, since their trigger foods are not excepted, but the 2% limit is reassuring.

Guidance on Spirometry and Peak Flow Measurements

  • Click to View as a PDFThe Task Force has received a few letters related to our Suggestions or Considerations for Resuming Practices document and our statement in that document that spirometry and peak flow measurements are “high risk” procedures. We want to reiterate that such considerations are fluid and affected by your local situation. We assumed that any patient, even with screening, could be an asymptomatic or pre-symptomatic infected patient since the availability and reliability of testing remains in question and the incidence of asymptomatic infected patients is likely to be unknown. We also know that current PPE supply is variable and an office may not be able to adequately protect their staff. The CDC has provided some conflicting information. On the one hand, they state in their guidance for schools that peak flow measurements are not considered a risk because forced exhalation is not a method of infection transmission, but then state to consider the use of PPE in such situations. In their guidance on aerosol-generating procedures, they state that the data is lacking and they are unable to provide a list of aerosol-generating procedures.
  • The Task Force remains concerned about spirometry and forced exhalation being potential avenues of viral transmission. A potential example of this is a published report (Hamner L, Dubbel P, Capron I, et al. High SARS-CoV-2 Attack Rate Following Exposure at a Choir Practice — Skagit County, Washington, March 2020. MMWR Morb Mortal Wkly Rep 2020;69:606–610. DOI: http://dx.doi.org/10.15585/mmwr.mm6919e6) where a single infected and symptomatic individual appears to have infected 32 (confirmed, and a potential additional 20) other individuals (out of 61 total people in the room) during a 2.5 hour choral practice (where face masks and physical distancing were NOT practiced).
  • Also, spirometry and peak flows in patients with bronchial hyperresponsiveness often results in cough, and coughing has been shown to be a route for infection transmission.
  • Therefore, at this time, the Task Force has not changed its opinion that these procedures are high risk, but recognizes that each practice is different with respect to physical structure, knowledge of their community, and availability of PPE. Ultimately, the decision to perform these tests rests with the individual practitioner.
  • Alternative approaches to performing these tests in the office include providing a patient with a peak flow meter to be used at home before a visit, or utilizing one of the home FEV1 monitoring systems.

Please continue to regularly visit the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 22, 2020

Here are today's important updates:

From the CDC

  • As the community around us “re-opens” and we consider resuming practice, allergists need to remind their patients, particularly those most vulnerable, that COVID-19 spreads easily in groups. There are myriad examples, but specifically outbreaks reported in the Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC) include spread in a church gathering and a choir practice. This doesn’t just affect older patients. In the church gathering, the largest infected group were 18 to 64-year-olds.
  • Multisystem inflammatory syndrome slides and the recorded presentation can be obtained here. This Clinician Outreach and Communication Activity call presents data and treatment information on two cohorts with this disorder, one from New York and the other from the UK. Symptoms varied in the two cohorts except for fever, but most patients in both presented with GI symptoms, with a majority having shock and myocardial involvement, with markedly elevated inflammatory markers. Treatment varied between the two groups, but IVIG and systemic steroids were used in a majority of patients. Prognosis was pretty good, only one death among 60+ patients.
  • Information for schools newly released by the CDC has some FAQs that are important for allergists in counseling parents of school-aged children. The two questions of note relate to management of an asthma attack in school and use of a school stock albuterol inhaler.

State Level Information

  • Many members have asked for information on COVID-19 regulations at the state level. Although the AAAAI doesn’t track state regulations on a consistent basis, here are two excellent websites that do track each state, with interactive, ongoing information: the National Governors Association and the Council of State Governments. Here is a resource from the American Academy of Pediatrics specifically on telehealth and state plans.

Interstate Medical Practice

  • For some time now, although it's been recently increasing, states have formed interstate licence compacts which offers a pathway to licensure for practitioners who wish to practice in multiple states. The Centers for Medicare & Medicaid Services (CMS) has determined that these compacts will be treated as valid, full licenses for the purpose of meeting CMS’ federal license requirements. CMS notes that MACs will accept CMS-855 enrollment applications from providers reporting an interstate license compact.

COVID-19: Payment for Diagnostic Laboratory Tests

  • As testing becomes more available and allergists are considering resuming practice, CMS released additional clarification on May 19. Healthcare providers may bill Medicare and other health insurers for SARS-CoV-2 tests performed on or after February 4 using HCPCS code U0001 for tests developed by the CDC, or U0002 for non-CDC lab tests. Health providers can also bill Medicare for tests using these CPT codes: 87635 for infectious agent detection by nucleic acid tests for dates of service on or after March 13, or 86769 and 86328 for serology tests for dates of service on or after April 10.

Neutralizing Antibody

  • You have undoubtedly heard about this one, in the search for treatment for COVID-19. Published in Nature on May 18, the researchers identified several monoclonal antibodies from memory B cells from a patient who had survived SARS in 2003, several of which were directed at targets on the coronavirus spikes. One of the antibodies appeared to be particularly effective at targeting and disabling the spike protein that promotes SARS-CoV-2 entry into cells in vitro. Combining this antibody with other weaker antibodies appeared to enhance the effect. The research team still needs to show that this works in living systems. This has the potential to be used in prophylaxis or treatment.

Serologic Testing and Herd Immunity

  • The World Health Organization director announced recently that only about 20% of the population, even in the hardest hit areas, had coronavirus antibodies. While there remain questions about the accuracy of testing, the number of patients with immunity to this virus would need to approach 70% of the population to achieve herd immunity, according to the Johns Hopkins Bloomberg School of Public Health.

Latest Updates for HHS Provider Relief Fund

  • The Department of Health and Human Services (HHS) has once again updated the FAQs on the CARES Act Provider Relief Fund, with many updates on May 20.
  • Modified or new questions: What action does a provider need to take after receiving a payment? How can I return a payment? Is there a public list of providers and the payments they received? What should I do if a General Distribution payment is greater than expected or received in error? In the case of a merger of a provider entity (billing TIN) into another entity (billing TIN), or the consolidation of two or more entities (each with a billing TIN), resulting in the creation of a new entity (single billing TIN) between January 1, 2018, through January 31, 2020, how should the entities apply? How should an organization currently undergoing a change in ownership to purchase a practice report revenue in its application? An organization that sold part of a practice in 2019 or January 2020 received a payment under the General Distribution that reflected the 2019 Medicare fee-for-service billing of that part of the practice. Can it return a portion of the payment for the part of the practice it no longer owns? A parent entity submitting an application for a General Distribution payment from the $20 billion payment tranche has more than 20 subsidiaries with billing TINs. How should it complete the application in the Provider Relief Fund Payment Portal?
  • Probably most important to the majority of our members is: What should I do if a General Distribution payment is greater than expected or received in error? It states: Providers that have been allocated a payment must sign an attestation confirming receipt of the funds and agree to the Terms and Conditions within 45 days of payment via ACH or within 60 days of check payment issuance. If a provider believes it was overpaid or may have received a payment in error, it should reject the entire General Distribution payment and submit the appropriate revenue documents through the General Distribution portal to facilitate HHS determining their correct payment. If a provider believes they are underpaid, they should accept the payment and submit their revenues in the provider portal to determine their correct payment.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, May 18, 2020

The AAAAI COVID-19 Response Task Force has created a list of Suggestions or Considerations for Resuming Practices that includes staff safety protocols, practice space logistics, and a classification of low, medium and high-risk procedures.

Click the image to download a PDF that you can easily print or share. You can also read a full text version.


Here are today's important updates:

HEROES Act Preliminary Information

Here are the key health policies in H.R. 6800, which still faces scrutiny in the Senate and with the administration:

  • Provides $75 billion in grants to state, local, tribal and territorial health departments to support testing, contact tracing, isolation or quarantine while requiring the Centers for Disease Control and Prevention to establish a coordinated evidence-based testing system, and creates centralized national reporting of testing capacity and results.
  • Provides stable and affordable health coverage for millions with subsidies for the cost of COBRA premiums, allows state Medicaid programs to cover COVID-19 treatment for uninsured, and establishes special enrollment periods for Affordable Care Act exchanges.
  • Ensures all can access COVID-19 treatment without concern for cost by eliminating cost sharing for Medicaid, Medicare, TRICARE, VA and private health insurance, requires coverage of items and services related to treatment, and mandates coverage for a vaccine with no cost-sharing.
  • Stabilizes and reinforces the public health system by making supply chain improvements, investing in vaccine manufacturing capacity, and requires the Department of Health and Human Services (HHS) to create a distribution and administration plan, improves national stockpile management, authorizes funding for the Medical Reserve Corps, and establishes a loan repayment program to enhance recruitment of a public health workforce.
  • Supports hospitals and frontline healthcare providers by appropriating an additional $100 billion into the Provider Relief Fund and provides clear guidance on efficient and equitable distribution, increases payments to facilities that serve a high proportion of Medicaid patients, improves the Accelerated and Advance Payment Program (which is currently on hold) by lowering the interest and extending the payment period.
  • Supports state governments and their Medicaid programs by increasing the Federal Matching Assistance Percentage by 14% through June 30, 2021.
  • Additional actions: provides nearly $1 trillion to state, local, territorial and tribal governments to pay first responders, healthcare workers and teachers, provides a second round of economic impact payments of $1,200 per family member, enhances the employee retention tax credit, strengthens the Paycheck Protection Program (PPP) and provides an additional $10 billion for the Economic Injury Disaster Loan (EIDL) program, extends the weekly $600 federal unemployment payments through January, and adds $175 billion in new rent and mortgage assistance.
  • Changes to PPPExtends the authorization period to December 31 from June 30, or sooner if funds are exhausted. The Small Business Administration (SBA) must set aside at least 25% of PPP funds to guarantee loans issued to eligible recipients with 10 or fewer employees. Any amounts returned from canceled loans would be reserved to guarantee new loans issued to recipients with 10 or fewer employees. Expands the PPP eligibility rules to cover nonprofit organizations of any type or size including 501(c)(6) trade associationsExtends the forgiveness period to cover costs incurred over 24 weeks or through December 31, whichever comes first (was 8 weeks). Bars the SBA from limiting loan forgiveness for expenses other than payroll (including PPE), expands forgivable expenditures to include payments on refinanced disaster loans and interest payments on additional types of debt, and maintains forgiveness amounts for businesses that were unable to rehire employees or resume business levels as of February 15, or find similarly qualified workers by the end of the year.
  • Accelerated and Advance Payment Programs modified and interest rate reduced to 1%. Provides up to one year before claims are offset and sets a recoup percentage maximum of 25% per claim, with up to two years for the outstanding balance to be paid.
  • And much, much more that we will report on as we can.
  • REMEMBER, THIS BILL STILL HAS TO PASS THE SENATE AND BE SIGNED BY THE PRESIDENT, WHO HAS ALREADY DECLARED IT DOA.

SBA and Treasury Release PPP Loan Forgiveness Application 

  • We still have to abide by the current regulations, even though they may change. Here is the website for this application.

Update on CMS Ruling on Telephone Payment

  • Just in from the American Medical Association (AMA): The Centers for Medicare & Medicaid Services (CMS) made the new payments for telephone-only visits retroactive to March 1. CMS specifically told the AMA that the MACs will be expected to automatically adjust retroactive changes to the claim payment, so practices will not have to resubmit the claims. CMS also noted that it will take time to implement these changes, and recommends that practices give their MACs some time to catch up and then check with the MACs if they have questions. Apparently CMS implemented a new Physician Fee Schedule on April 30 for these codes.

Update on HHS Provider Relief Fund

  • Many questions and answers have been listed on this webpage on May 12 and 14.
  • There are too many to list here, but there are a couple of highlights and corrections related to previous statements. The distribution of the additional $20 billion that was discussed in an earlier email is proportional to a provider’s share of 2018 (or the latest completed tax year) NET patient revenue. We previously reported this as gross revenue. This revenue is regardless of the provider’s payer mix. Total payments are determined based on the lesser of 2% of a provider's net patient revenue for 2018 (or most recent completed tax year) or the sum of incurred losses for March and April. If your initial distribution was at least 2% of annual patient revenue, you will not receive additional payments. You can estimate your total payments from the $50 billion Provider Relief Fund using this equation: (Individual Provider Revenues/$2.5 trillion) x $50 billion = expected combined general distribution.

More on Asthma and COVID-19

  • A pre-print paper to be published in JACI: In Practice, which is a single center report with a small number of subjects, found that those with self reported asthma who were intubated for COVID-19 had a longer intubation course than those without asthma. Interestingly, this was seen only in those younger than age 65, but again there were a small number of subjects.

More on Serologic Testing

  • The Food and Drug Administration (FDA) has published a webpage on the current EUA-approved serologic testing with respective sensitivity and specificity numbers for each test. A caveat is that the data is from the company's own testing and the details of the tested population is not given.
  • The AMA has published very useful guidance on Serological Testing for SARS-CoV-2 Antibodies that you can print and share with colleagues and patients.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. If you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, May 12, 2020

Here are today's important updates:

United Healthcare News

  • United Healthcare announced on May 8 that they are waiving all cost shares (copays, coinsurance and deductibles) for their Medicare Advantage members for all covered office-based professional services performed by both primary care and specialists starting May 11 until at least September 30.
  • Coverage for telehealth mirrors the recent Centers for Medicare & Medicaid Services (CMS) waivers and new interim rule.

Updated FAQs on HHS Provider Relief Fund

  • The Department of Health and Human Services (HHS) has released updated FAQs related to the CARES Act Provider Relief Fund, which can be accessed here.
  • Any provider who has already received a payment from the Provider Relief Fund as of 5:00 pm EST Friday, April 24 can and should apply for additional funding via the Provider Relief Fund Application Portal.
  • Providers who have not received funding as of 5:00 pm EST Friday April 24 are NOT eligible to use the Provider Relief Fund Application Portal, HOWEVER these providers may still be eligible for payments from the Provider Relief Fund through targeted distributions for care of the uninsured, areas of high impact, or rural health care. Descriptions are noted here.
  • To be eligible for the general distribution, a provider must have billed Medicare in 2019 and provide or provided after January 31, 2020, diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. HHS broadly views every patient as a possible case of COVID-19.

NIH and COVID-19

  • At the Senate HELP Committee hearing on May 7, Francis Collins, MD, PhD, director of the National Institutes of Health (NIH), announced that they had started a partnership with 18 pharmaceutical companies called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). He also announced the recent Rapid Acceleration of Diagnostics (RADx) project. This project is engaging scientists across the country to improve current tests and advance completely new technologies, ideally for point of care testing. More information on that project can be found on the NIH website here.

Food Allergy Issues Again

  • Interim Guidance for Administrators of US K-12 Schools and Child Care Programs from the Centers for Disease Control and Prevention (CDC) recommends avoiding mixing students in common areas and includes the example of having students eat breakfast and lunch in the classrooms. The allergist needs to be sure to discuss this issue with food allergic children and their parents.
  • The Food Allergy & Anaphylaxis Connection Team (FAACT) has written to the director of the CDC asking for exceptions for classrooms with food allergic students.

What Are Other Practices Doing?

  • The Regional, State and Local Allergy, Asthma and Immunology Societies Assembly has provided us with some feedback on what practices are doing around the country. Responses from New Jersey and Texas indicate that most practices are doing telemedicine. Some are seeing a few patients in person and most continue allergy shots. All have seen a reduction in revenue and income, some approaching 50%. Most are not performing any pulmonary function procedures. It is important to understand that New Jersey is one of the hot spots and Texas is an early re-opening state, so the approach is expected to be somewhat different. Most offices require staff and patients to wear masks or face coverings, and the amount of PPE the staff is wearing depends on the supply. Some have placed “sneeze guards” at the check-in area, and one practice retrofitted waiting room chairs with table paper! Some are trying to keep their staff employed with the help of Small Business Administration loans, but many others have laid off or furloughed staff.
  • Academic centers in Chicago/the Midwest and Seattle are announcing pay cuts across the board for leadership and staff varying from 10-20%. In addition, they are trimming expenses, hires and capital projects.
  • Many academic centers have also removed academic enrichment funds to be used for travel/attendance at professional meetings and have placed travel restrictions pertaining to both professional and personal trips.

What Are Other States Doing?

  • Questions have come up about state regulations concerning telehealth, licensing, etc. Please visit the AAAAI COVID-19 advocacy page and select the State Resources link within the set of continually updated links from AAAAI’s professional advocacy team, Hart Health Strategies. Make sure you clear your browser cache before each visit to access the latest news.

Keep regularly visiting the AAAAI COVID-19 resources page, and if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 8, 2020

Here are today's important updates:

CDC Revises Ending Isolation Recommendations

  • In the context of community transmission where continued testing is impractical, the available evidence is nicely summarized on this webpage. The Centers for Disease Control and Prevention (CDC) has revised their terminology and recommendations to establish the end of isolation. They do attach a disclaimer that the practical application of a symptom-based strategy cannot prevent all infections, but the data they present is pretty reassuring that these recommendations are safe.
  • Symptoms-based strategy: For persons recovered from COVID-19 illness, isolation should be maintained for at least 10 days after illness onset AND at least three days (72 hours) after recovery.
  • Either a test-based strategy or a symptom-based strategy with more stringent requirements (not specified) may be used for recovered persons for whom there is low tolerance for post-recovery SARS-CoV-2 shedding and infectious risk because they are: 1) persons who could pose a risk of transmitting infections to vulnerable persons at high risk for mortality from COVID-19 or persons who support critical infrastructure; 2) persons normally residing in congregate living facilities (includes ships); 3) persons who because they are immunocompromised may have prolonged viral shedding.
  • Recommendations for immunocompromised patients have not changed from March 16. When possible, a test-based strategy is recommended: resolution of fever without fever-reducing medication AND improvement in respiratory symptoms AND negative results of a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) approved molecular assay for COVID-19 from at least two consecutive upper respiratory swab specimens collected >/=24 hours apart.
  • For healthcare personnel (HCP), there are approaches, one for symptomatic HCP with suspected or confirmed COVID-19, which includes either the symptom-based or test-based strategies outlined above. The other is for asymptomatic confirmed COVID-19 HCP where either a time-based strategy where the HCP is excluded from work until 10 days have passed since the date of their first (+) COVID-19 test or a test-based strategy as noted above. If the HCP develops symptoms, then revert to the symptom-based or test-based strategy for symptomatic HCP.
  • HCP should wear a mask at all times after returning to work until the symptoms have completely resolved or they are back to baseline and self-monitor for symptoms.

CMS New Interim Final Rule - Key Takeaways for Allergists

  • Time used for level selection for E/M telehealth visits: The Centers for Medicare & Medicaid Services (CMS) is finalizing on an interim basis, for the duration of the public health emergency for the COVID-19 pandemic, that the typical times for purposes of level selection for an office/outpatient E/M are the times listed in the CPT code descriptor. In the previous Interim Final Rule published March 31, the time was defined as all of the time associated with an E/M on the day of a visit, not just face-to-face time, as was listed in a CMS public use time file. For NP visits, use 15 minutes for 99202, 30 minutes for 99203, 45 minutes for 99204 and 60 minutes for 99205. For EST patients: 10 minutes for 99212, 15 minutes for 99213, 25 minutes for 99214, and 40 minutes for 99215.
  • Merit-based Incentive Payment System (MIPS) Qualified Clinical Data Registries (QCDRs): CMS is delaying by one year the new requirements that QCDRs collect data on a QCDR measure and that QCDR measures are fully developed and tested prior to self-nomination. These requirements will begin with the 2022 performance period.
  • Clarification of new telehealth waivers: Although the wording is confusing, our consultants confirmed that CMS was reluctant to remove the video requirement for telehealth E/M services provided under the codes 99212-99214. What they did is allow telephone only E/M services, billed using the current telephone coding, but increased the payment to levels close to what is paid for in-office visits for 99212-14. YOU WILL HAVE TO UPDATE YOUR BILLING SOFTWARE to reflect the new charges, otherwise Medicare will pay for the lower charge. PHONE ONLY: USE TELEPHONE CODES (billed at the higher rate), VIDEO/AUDIO: USE REGULAR E/M CODES.

Update to CARES Act Provider Relief Fund 

  • The Attestation Portal has been updated to provide additional information regarding the $50 billion Provider Relief Fund. The time limit to attest has been extended to 45 days from the time of receipt of the funds.
  • The first $30 billion has already been distributed, and the next $20 billion is on its way.
  • The Department of Health and Human Services (HHS) has clarified that the total distribution for a provider should be approximately 2% of 2018 gross revenue, based on the following instruction: To calculate your estimated total allocation, divide your “Gross Receipts or Sales” or “Program Service Revenue” by 2.5 trillion and then multiply by 50 billion. (Gross Receipts or Sales) / 2,500,000,000,000) x 50,000,000,000
  • To determine whether a provider will likely receive additional funding from the $20 billion, a provider should examine their 2018 gross patient revenue, as detailed: If the provider received less than 2% of 2018 gross revenue from the initial $30 billion distribution, then the provider may be eligible to receive additional funding up to the 2% calculation. If the distribution from the initial $30 billion is more than 2% of 2018 gross revenue, then the provider will likely need to contact the CARES Provider Relief Hotline to determine next steps. Note that this calculation should be done for all TINs tied to 2018 net patient revenue amount.
  • Further, HHS has stated (per below) that the “names of payment recipients and the amounts received” will be publicly available for “all providers who attest to receipt of a payment and acceptance of the Terms and Conditions.” HHS further notes that a provider should not attest unless the payment is consistent with the estimated allocation.
  • *To estimate the amount likely to be received via this portal application, subtract the amount of payments already received from your total estimated total allocation above.
  • Please do not attest if the payments you have received already exceed your estimated total allocation. Please contact the CARES Provider Relief Hotline at (866) 569-3522 if you believe that you have received an overpayment.

NIAID Study on Children with COVID-19 (HEROS Study)

  • This study will determine how many children are infected and how many go on to have symptoms.
  • The HEROS study team will enroll 6,000 people from 2,000 families already participating in NIH-funded research in 11 U.S. cities and follow them for six months.
  • Healthy children, as well as children with asthma and allergies, will be included.
  • You can read more here.

SBA Economic Injury Disaster Loans Have Changed?

  • According to an article in The Washington Post, the Small Business Administration (SBA) has reduced the maximum loan amount from $2 million to $150,000 and is not accepting new applications. Here is what it says today on the SBA website: SBA has resumed processing Economic Injury Disaster Loan (EIDL) applications that were submitted before the portal stopped accepting new applications on April 15 and will be processing these applications on a first-come, first-served basis. SBA will begin accepting new EIDL and EIDL Advance applications on a limited basis only to provide relief to U.S. agricultural businesses.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, May 5, 2020

The AAAAI COVID-19 Response Task Force has created a new document with Suggestions or Considerations for Resuming Practices.

Click here for a PDF that has been formatted to allow you to easily print or share the document, or access the full text version here from the AAAAI COVID-19 resources page.

The resuming of a practice depends on a risk assessment of community spread of COVID-19 cases and your state’s current status with respect to being open or closed. It is important to realize that this is a fluid and changing environment, that risk may change with time and decisions may need to change.

Everything in this document presumes that the actual infectious state of your patients is unknown and that asymptomatic or pre-symptomatic patients can spread the virus.

Please continue to send any questions to practicematters@aaaai.org.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, May 1, 2020

Here are today's important updates:

Clarification Concerning Coding for Procedures and Telemedicine Visits Performed on the Same Day

  • Questions have come up about how to code for the patient who has skin testing or an immunotherapy injection on the same day as a telemedicine E/M visit. This might arise in multi-location practices where the patient goes into one office for a procedure, but then has an E/M visit via telemedicine from another provider.
  • According to AAAAI coding expert Teresa Thompson: You may use two modifiers on a CPT code. You would place the 25 and then the 95 modifier. It will be carrier dependent on which procedures the payer will recognize for telehealth payment. You would not use any modifier on the allergy shot or test if it were performed in person. Place of service would be 11 for the in-person service and then payer dependent on place of service (02 or 11) for the E/M.

Templates and Talking Points for Local Media Outreach

  • It is critical for the practicing allergist to be seen as the expert when it comes to how COVID-19 may impact patients with allergies, asthma and immunologic disorders.
  • The AAAAI has created a template media alert describing the unique perspective an allergist can offer, a template press release on what patients need to know about asthma and COVID-19, and a set of talking points.
  • Update the templates and send them to media contacts in your local area and use the talking points to prepare for interviews. Please note that while the AAAAI is providing these materials to help you, you will be speaking on your own behalf in any interviews you may give.  
  • These communication and outreach tools have also been posted to the AAAAI Original Resources section of our COVID-19 resources page.

Update on Vaccines

  • New York Times report notes that scientists at the Oxford University Jenner Institute say their experimental vaccine protected rhesus monkeys from illness with exposure to SARS-CoV-2. They are scaling up a 6,000 person clinical trial. China has started a 144 participant clinical trial after their vaccine candidate also protected monkeys.

Legislation on Medical Equipment and Supplies

  • Senate Democrats Baldwin, Murphy and Schumer have introduced legislation that lays out a framework for an effective COVID-19 response by federalizing and adding critical oversight and transparency to the supply chain. Forty-six other Democrats have signed on to the Medical Supply Transparency and Delivery Act, which has also received support from unions and nurses. Representatives Porter, Crow, Slotkin and Ryan have introduced companion legislation in the House. Read more about the bill here. Write your members of Congress to support this if you agree.

New Rules and Waivers from CMS

  • The Centers for Medicare & Medicaid Services (CMS) announced a new round of “sweeping changes” on April 30. Here is how they might affect allergists, although most of the changes were announced at the end of March.
  • Pharmacists can work with a physician or other practitioner to provide assessment and specimen collection services, and the physician or other practitioner can bill Medicare for the services. Pharmacists also can perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory, in accordance with a pharmacist’s scope of practice and state law. With these changes, beneficiaries can get tested at “parking lot” test sites operated by pharmacies and other entities consistent with state requirements. Such point-of-care sites are a key component in expanding COVID-19 testing capacity.
  • CMS will allow certain provider-based hospital outpatient departments that relocate off-campus to obtain a temporary exception from payment linked to the PFS and continue to be paid under the OPPS. Importantly, hospitals may also relocate outpatient departments to more than one off-campus location, or partially relocate off-campus while still furnishing care at the original site.
  • CMS is broadening the list of services conducted by audio-only telephone services to include many behavioral health and patient education services. CMS is also increasing payments for these telephone visits to match payments for similar office and outpatient visits. This would increase payments for these services from a range of about $14-$41 to about $46-$110. The payments are retroactive to March 1, 2020.
  • CMS is revamping its processes to add new telehealth services, and will be using a subregulatory basis, considering requests by practitioners, instead of its rulemaking process, which should speed up the process.
  • CMS is waiving the video requirement for certain telephone evaluation and management services, and adding them to the list of Medicare telehealth services. As a result, Medicare beneficiaries will be able to use an audio-only telephone to get these services.
  • Virtual check-in services, or brief check-ins between a patient and their doctor by audio or video device, could previously only be offered to patients that had an established relationship with their doctor. Now, doctors can provide these services to both new and established patients.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, April 28, 2020

Here are today's important updates:

Testing

  • Lay and medical press reports are talking about serological testing for SARS-CoV-2. Assays for IgM and IgG antibodies are being developed by several commercial laboratories as well as university labs.
  • IgG assays measure the antibody response to SARS-CoV-2, indicating a prior infection (assuming the test accurately distinguishes IgG against SARS-CoV-2 from IgG directed against other coronaviruses, such as circulating CoV) that MAY indicate immunity. It may also help identify sources for donation of convalescent plasma for treatment of patients with COVID-19. We do not know whether the presence of IgG antibody signifies protection, or how long that protection lasts.
  • Antibody tests should not be used to diagnose current COVID-19 infections, and cannot differentiate between those with a current infection (who could still be shedding virus) and those who have already recovered from an infection and are no longer shedding virus.
  • Serological tests typically undergo an approval process by the Food and Drug Administration (FDA), but during this pandemic, a few tests have been authorized through Emergency Use Authorization (EUA) which means that the FDA has reviewed the test, the manufacturer of the test has validation data, and the FDA has authorized the test to be used. To date, the FDA has authorized four tests under the EUA.
  • To help speed up the process, the FDA has developed a collaboration with the National Cancer Institute, National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and Prevention (CDC) to help evaluate tests, including those currently on the market as well as those not yet available.
  • Last month, as part of a broader strategy, the FDA issued a policy explaining that FDA does not intend to object when developers of serological tests market or use their tests without prior FDA review where: 1) the tests are validated by the developer to determine that they are accurate and reliable, 2) notification of the developer’s validation is provided to FDA, and 3) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis. The FDA policy does not apply to at-home specimen collection or at-home testing. Once the National Institutes of Health (NIH) has been able to provide further data, these tests may be authorized under the EUA or approved.
  • To facilitate awareness of these serological tests, the FDA has been posting on its website the tests for which it has received a notification under this policy since mid-March. They have also updated their website to better clarify which tests have been authorized by FDA and which have not been authorized. However, some test developers have misused the serology test kit notification list to falsely claim their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19.
  • See here and here for more information.

NSAIDs and COVID-19

  • In case you were still wondering, the World Health Organization carried out a rapid systematic review on March 20 on NSAIDs and respiratory viral infections (not just COVID-19).
  • Bottom line: "At present, there is no evidence of an impact of NSAID use on severe adverse events, acute health care utilization, long-term survival or quality of life in patients with COVID-19."
  • Limitations of the study: There was no direct evidence from patients with COVID-19, SARS or MERS available, and studies were largely underpowered to detect rare adverse events.

Treatment for COVID-19

  • The NIH has established a “living” webpage that offers a nice overview and perspective on treatment for COVID-19. As expected, no treatment has been identified that has proven effectiveness.

Counterfeit Respirators

  • The CDC and National Institute for Occupational Safety and Health (NIOSH) have posted warnings about counterfeit respirators and how to spot them. They will post the names of the counterfeit manufacturers on this website as they become aware of them.
  • NIOSH-approved respirators have an approval label on or within the packaging of the respirator (i.e., on the box itself and/or within the users’ instructions). Additionally, an abbreviated approval is on the FFR itself. You can verify the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page to determine if the respirator has been approved by NIOSH. NIOSH-approved FFRs will always have one of the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.
  • Signs that a respirator may be counterfeit:
    1. No markings at all on the filtering facepiece respirator.
    2. No approval (TC) number on filtering facepiece respirator or headband.
    3. No NIOSH markings.
    4. NIOSH is spelled incorrectly.
    5. Presence of decorative fabric or other decorative add-ons (e.g., sequins).
    6. Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children).
    7. Filtering facepiece respirator has ear loops instead of headbands.

CMS Suspends Advance Payment Program

  • On April 26, the Centers for Medicare & Medicaid Services (CMS) announced it is suspending its Advance Payment Program for Part B suppliers effective immediately. This was the temporary loan program for advance payment of Medicare based on the previous years payments, to be paid back over time.
  • Funding will continue to be available from the Provider Relief Fund.
  • CMS had approved 24,000 applications advancing $40.4 billion to health care providers (does not include hospitals).

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 24, 2020

Here are today's important updates:

CARES Act Provider Relief Fund Update

  • The first tranche of relief checks, $30 billion in total, have been mailed out to practitioners who see Medicare patients, with the last checks going out April 17.
  • An additional $20 billion is being distributed beginning today, Friday, April 24, to those providers with a relatively small share of their revenue coming from Medicare FFS, such as children’s hospitals and those practices who see a lot of Medicaid patients. A portion of providers will automatically be sent an advance payment based off the revenue data they submit in Centers for Medicare & Medicaid Services cost reports. Providers without adequate cost report data will have to submit their revenue information to a portal opening this week for additional general distribution funds, which will go out weekly as information is validated. Even those who receive automatic payments will need to submit revenue information to be verified. If a provider received a first stimulus amount, he/she may still receive this second stimulus, which is proportional to providers’ share of 2018 net patient revenue.
  • $10 billion will be allocated for hospitals in areas that have been particularly impacted by COVID-19.
  • Allocation for treatment of the uninsured: Every healthcare provider who has provided treatment for uninsured COVID-19 patients on or after February 4 can request reimbursement through the program and will be reimbursed at Medicare rates, subject to available funding. Steps will involve: enrolling as a provider participant, checking patient eligibility and benefits, submitting patient information, submitting claims, and receiving payment via direct deposit. Providers can register for the program on April 27, 2020, and begin submitting claims in early May 2020. Visit this website for more information. Balance billing not allowed.

Latest Coronavirus Relief Package

  • The total package is $484 billion, bringing the total amount of relief to $2.8 trillion dollars.
  • $310 billion will replenish the Small Business Administration (SBA) Paycheck Protection Program, with $60 billion earmarked for community banks and smaller lenders, which should help smaller and rural businesses who tend to use these types of financial institutions. An additional $60 billion is directed to the SBA for emergency business grants and loans (e.g., Economic Injury Disaster Loan program).
  • $75 billion goes to hospitals and community health centers.
  • $25 billion will boost COVID-19 testing. These monies will be divided between the federal and state governments with $11 billion going to states and localities to scale up testing capacity, $1 billion to the Centers for Disease Control and Prevention for surveillance, epidemiology, lab capacity expansion, and contact tracing, $1.8 billion to the National Institutes of Health to develop, validate and improve testing, $1 billion for the Biomedical Advanced Research and Development Authority for advanced research, and development of testing or related supplies, $22 million for the Food and Drug Administration to support activities associated with testing, $825 million for community health centers and rural health clinics, and up to $1 billion may be used to cover the costs of testing for the uninsured.
  • Check with your banker about the status of your application. If you haven’t applied yet and are getting mixed messages from your banker, remember that smaller practices may have better luck with community banks or lenders.

Keep regularly visiting the AAAAI COVID-19 resources page and advocacy page. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, April 21, 2020

Before we get into the important updates we have for you today, we wanted to alert you that the Department of Health and Human Services has again released an updated set of terms and conditions related to the release of the $30 billion in funding from the Public Health and Social Services Emergency Fund. You can find more details by visiting the AAAAI COVID-19 advocacy page and selecting the Physician Provisions link. Hart Health Strategies, the professional advocacy partner of the AAAAI, has been providing this continually updated information on critical issues related to COVID-19. Clear your browser cache before each visit to access the latest news. And don't forget about the JACI: In Practice Twitter chat tomorrow, April 22, at 8:30 pm EDT about this article on Clinician Wellness During the COVID-19 Pandemic. Use the hashtag #JACIIPCOVID.

AMA Advocacy Efforts

  • In a letter to Congressional leaders, the American Medical Association (AMA) urges additional direct financial support for physician practices, additional funding for the Small Business Association Paycheck Protection Program, implementing a positive Medicare fee update for 2020 and beyond, and postponing recoupment of advances until 365 days after the payment is issued, instead of the current 120 days. Please contact your members of Congress today to tell them we need more help.
  • A letter to the Federal Emergency Management Agency urged the creation of a national system for acquisition of PPE, as well as a system of distribution managed by the federal government.
  • Resources that might help state allergy societies and medical societies on the AMA Advocacy Resource Center include an updated state telemedicine chart and COVID-19 state policy guidance on telemedicine, as well as options to address liability protections, reduce administrative barriers and expand coverage.
  • The AAAAI advocacy team has been working closely with AMA advocacy to support these efforts.

Financial Support

  • There was hope that Congress may have reached some sort of consensus this past weekend on additional funding for practices. Now there appear to be sticking points on funding for testing, and the vote may be delayed until later this week.

MIPS Reporting Relief

  • Practices can submit an Extreme and Uncontrollable Circumstances application until April 30 if you are unable to complete your data submission. Completion of the application will result in a neutral payment adjustment. Failure to file the application could result in a negative payment adjustment for practices that have to report.

Updated Guidance from CDC for Healthcare Settings (Updated April 13, 2020)

  • You can read more details here.
  • Implement source control for everyone entering a healthcare facility (staff, patients, visitors) to help prevent transmission from asymptomatic or pre-symptomatic individuals.
  • Measures should be implemented before patient arrival and upon arrival.
  • Temperature and symptom screening should still be performed, but this is not sufficient to prevent transmission.
  • Healthcare facilities should consider implementing policies requiring everyone to wear a cloth face covering (if tolerated and over age 2) while in the building, regardless of symptoms. Patients and visitors should be instructed to avoid touching the face covering, but if they must, they should perform hand hygiene before and after adjusting the mask. Patients may remove their face covering when in the patient room, but should put them back on (see hand hygiene above) if anyone enters the room.
  • HCP should wear a facemask at all times while in the facility. If there are anticipated shortages of facemasks, facemasks should be prioritized for HCP and then for patients with symptoms of COVID-19 (as supply allows). Cloth face coverings should NOT be worn instead of a respirator or facemask if more than source control is required. HCP should also self screen for symptoms and fever before every shift.
  • Clerical personnel or personnel not in patient care areas might continue to wear their cloth face covering while in the facility, but to avoid the risk of self-contamination, they should consider continuing to wear their respirator or facemask.
  • HCP who enter the room of a patient with known or suspected COVID-19 should adhere to Standard Precautions and use a respirator (or facemask if a respirator is not available), gown, gloves, and eye protection.
  • Manage visitor access by limiting points of entry, and limiting visitors to only those essential for care of the patient. Screen visitors as you do patients.

CMS Issues Recommendations to Re-Open Healthcare Systems

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 17, 2020

We have a variety of important updates for you today:

Management of Asthma and Allergies During the Pollen Season and COVID-19
Current data (emphasis on current) indicates that it is safe to use nasal and inhaled corticosteroids in the management of asthma and allergic rhinitis during the pandemic. It is probably even more important to use these medications to prevent asthma exacerbations and poorly controlled rhinitis with sneezing and rhinorrhea. It is also okay to use systemic corticosteroids when indicated for asthma exacerbations.

CARES ACT Provider Relief Payment Information

  • The CARES Act Provider Relief Fund Payment Attestation Portal is now open. Providers who have been allocated a payment from the initial $30 billion general distribution must sign an attestation confirming receipt of the funds and agree to the terms and conditions within 30 days of payment. The portal has a variety of steps, including confirmation of eligibility, billing TINs, verifying payment information, attestations (likely related to the terms and conditions), and confirmation.
  • As a reminder, payment by the U.S. Department of Health and Human Services (HHS) of this initial tranche of funds is conditioned on the healthcare provider’s acceptance of the terms and conditions (the link was provided in our April 16 message), which acceptance must occur within 30 days of receipt of payment. Not returning the payment within 30 days of receipt will be viewed as acceptance of the terms and conditions, so the provider must do the following: Contact HHS within 30 days of receipt of payment and then remit the full payment to HHS as instructed. The CARES Act Provider Relief Fund Payment Attestation Portal will guide providers through the attestation process to accept or reject the funds.
  • The American Medical Association has received several questions about how to verify eligibility for payment and who to contact when a physician believes they are eligible but did not receive a payment. HHS partnered with UnitedHealth Group (UHG) to deliver the stimulus payments, and physicians should contact UHG’s Provider Relations at 866-569-3522 about eligibility, whether a payment has been issued, and where it was sent. If a physician or practice did not already set up direct deposit through the Centers for Medicare & Medicaid Services or UHG’s Optum Pay, they will receive a check at a later date. Practices that would like to set up direct deposit now can call the UHG Provider Relations number.
  • The Small Business Administration (SBA) Paycheck Protection Program (PPP) is no longer accepting applications since the appropriated monies have been exhausted. The SBA announced that they had processed 1.637 million applications for $339 billion dollars as of April 14. The administration has not released information on how much money has been disbursed, but according to a Washington Post article, anecdotal reports from banks are that only a small proportion of the funds have been disbursed. If you have placed an application already, there is still a possibility of getting some money.

Physician Wellness and Resilience
The American Academy of Pediatrics (AAP) has a new webinar on physician resilience on the AAP YouTube page.

Convalescent Plasma

Genentech Letter on Home Administration of Xolair
Genentech sent a DHCP (Dear Health Care Provider) letter out this week announcing that after consultation with the FDA, they have proposed some criteria for home administration of Xolair. The Task Force would caution that practitioners carefully evaluate each individual patient if considering home administration. Just having an epinephrine auto-injector at home doesn’t always assure appropriate treatment of anaphylaxis. Once home administration starts, it will become the norm, regardless of the FDA black box warning, and in-office administration will likely become the outlier that will require PA.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Thursday, April 16, 2020

Before getting into today's Task Force message, we wanted to point out a new AAAAI podcast episode on Using Telemedicine to Provide Care for Allergic Conditions. It features Jennifer Shih, MD, who discusses the practical elements of performing virtual visits. You can listen here. A link to this new podcast episode has also been added to the AAAAI COVID-19 resources page.

The AAAAI COVID-19 resources page also has a new section on clinician wellness and resilience and JACI: In Practice will be hosting a Twitter chat on April 22 at 8:30 pm EDT on this paper: Clinician Wellness During the COVID-19 Pandemic: Extraordinary Times and Unusual Challenges for the Allergist/Immunologist. Use the hashtag #JACIIPCOVID during the chat. 

Comments From the Field
On the RSL call held on April 13, RSL governors shared their experience on getting loans through the Small Business Administration (SBA). Working with the bank that has had your business over the years is probably best, but some of the banks may be too worried about their liability. If you are having problems getting your bank to allow applications, there may be smaller community banks that are anxious for your business and would be willing to move forward a little more rapidly. Don’t be afraid to reach out.

The Task Force would like to know how all of you are coping, and what changes have you made? Don’t hesitate to email us at practicematters@aaaai.org and let us know what you need or what has worked for you.

Be Wary of Legislative Promises
Unfortunately, legislation often reflects politics and not promise. The regulations to fulfill that legislation are what matters, and those have been changing daily. Take everything with a large grain of salt. The AAAAI is trying to provide help on these issues as they arise.

HHS Relief Fund Certification
As an example of changing regulations, here is the latest version of Relief Fund Payment Terms and Conditions.

Key takeaways for recipient certification:

  • Provide, or provided after January 31, 2020, diagnoses, testing or care for individuals with possible or actual cases of COVID-19. Care does not have to be specific to treating COVID-19. The U.S. Department of Health and Human Services (HHS) broadly views every patient as a possible case of COVID-19. If you ceased operation as a result of the COVID-19 pandemic, you are still eligible to receive funds so long as you provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. If you haven’t received a check, please check this website to find out details on the payment process.
  • Payment will only be used to prevent, prepare for and respond to COVID-19, and payment is only for healthcare related expenses or lost revenue.
  • Payment will not be used to reimburse expenses or losses that have been reimbursed from other sources.
  • Special reporting required for any entity receiving more than $150,000 from any of the COVID-19 support programs.
  • Maintain appropriate records and cost documentation including, as applicable, documentation required by 45 CFR § 75.302 – Financial Management and 45 CFR § 75.361 through 75.365 – Record Retention and Access.
  • There is a Surprise Billing component as well. Accordingly, for all care for a possible or actual case of COVID-19, recipient certifies that it will not seek to collect from the patient out-of-pocket expenses in an amount greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network recipient.
  • None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II ($197,300).
  • For additional information, visit this website or the CARES Provider Relief Line can be contacted at (866) 569-3522.

Priorities for the Next $70 Billion
The current payment came from $30 billion of the $100 billion laid out in the CARES Act for provider relief. The Administration is working rapidly on targeted distributions that will focus on providers in areas particularly impacted by the COVID-19 outbreak, rural providers, providers of services with lower shares of Medicare reimbursement or who predominantly serve the Medicaid population, and providers requesting reimbursement for the treatment of uninsured Americans.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. And please remember if you need to refer back to any of the previous Task Force messages, you can do so here.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 13, 2020

Where Is This Pandemic Headed?
In a recent conversation with JAMA Editor Howard Bauchner, MD, Nicholas Christakis, MD, PhD, MPH, Director of the Human Nature Lab at Yale, discussed the current pandemic, with comparison to the 1957 flu epidemic. The key takeaway is that there may be a slight reduction in cases and spread this summer, but expect a return in the fall.

News on Vaccines
From the Foundation for Biomedical Research, a COVID-19 vaccine candidate being studied at the University of Pittsburgh is provoking the production of SARS-CoV-2 antibodies in mice and they are hoping to move the vaccine into human research soon. There are more than 50 vaccines in the pipeline now, with several being validated in animal studies. The virus doesn't appear to mutate quickly or evade the immune system, and scientists were already working on vaccines for other coronaviruses such as SARS and MERS that were showing promise in animal research.

Keep Well
Consider distancing yourself from the news. Read "Avoiding information overload during the pandemic", where University of Washington Information School Professor David Levy discusses some best practices for navigating our use of devices and the need to be thoughtful about the habits we have in place for choosing what we consume. Pro tip: Turn off your news app notifications.

Healthcare Worker Return-to-Work Criteria
Test-based strategy
Exclude from work until:

  1. Resolution of fever without the use of fever-reducing medications, and
  2. Improvement in respiratory symptoms (e.g., cough, shortness of breath), and
  3. Negative results of a Food and Drug Administration Emergency Use Authorized molecular assay for COVID-19 from at least two consecutive nasopharyngeal swab specimens collected 24 hours or more apart (total of two negative specimens). See Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19).

Non-test-based strategy
Exclude from work until:

  1. At least three days (72 hours) have passed since recovery defined as resolution of fever without the use of fever-reducing medications and improvement in respiratory symptoms (e.g., cough, shortness of breath); and,
  2. At least seven days have passed since symptoms first appeared.

After returning to work
Healthcare personnel should:

  1. Wear a facemask at all times while in the healthcare facility until all symptoms are completely resolved or until 14 days after illness onset, whichever is longer.
  2. Be restricted from contact with severely immunocompromised patients (e.g., transplant, hematology-oncology) until 14 days after illness onset.
  3. Adhere to hand hygiene, respiratory hygiene, and cough etiquette in the Centers for Disease Control and Prevention's interim infection control guidance (e.g., cover nose and mouth when coughing or sneezing, dispose of tissues in waste receptacles).
  4. Self-monitor for symptoms, and seek re-evaluation from occupational health if respiratory symptoms recur or worsen.

Read more details here.

Summary of CMS Rulings/Resources
This link
provides a nice summary for clinicians on the waivers/regulations instituted by the Centers for Medicare & Medicaid Services (CMS) during the public health emergency and also has a nice list of resources.

CARES Act Deposits
CARES Act Provider Relief Fund deposits have started to be deposited into accounts. This amount is about 6.2% of your 2019 Medicare FFS (not including Medicare Advantage payments). The portal to attest to receipt of money and agreement of terms will be open the week of April 13, 2020. Attestation must be made within 30 days of receipt of funds. The deposit will come from the U.S. Department of Health & Human Services.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

 Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 10, 2020

Today we have an asthma and COVID-19 update:

  • The Centers for Disease Control and Prevention (CDC) released a new Morbidity and Mortality Weekly Report (MMWR) on April 8 that suggests a possible increased risk for hospitalization due to COVID-19 in asthma patients.
  • This study evaluated hospitalization for COVID-19 in the month of March in the United States, and includes co-morbid disease data from 180 patients (out of 1,482 total subjects in the study). In patients 18-49 years old who were hospitalized with COVID-19, 27.3% (12 out of 44) had a history of asthma. In those patients 50-64 years old asthma was present in 13.2% (7 of 53) and in those 65 years old or older asthma was found in 12.9% (8 of 62). Given the prevalence of asthma in the United States (around 10%), the percentage of patients in the 18-49 year old group with asthma is higher than would be expected in the general population. This suggests that those with asthma in the 18-49 year old age range may be at increased risk of hospitalization due to COVID-19.
  • The prevalence of asthma in this age group is similar to what has been seen with hospitalizations for seasonal influenza. Most likely, this indicates that uncontrolled asthma may be a risk for hospitalization with COVID-19. However, it is important to note that neither asthma control or severity was recorded in this report. Also, the severity of the COVID-19 infection is also not documented.
  • Wheezing was noted in 6.7% of patients (12 out of 180) and was spread amongst the three age groups. This may suggest that patients were not having traditional asthma exacerbations at the time of their hospitalization for COVID-19. This seems to fit with what has been heard anecdotally from EDs around the country—that they aren’t seeing asthma exacerbations due to SARS-CoV-2 (and matches what is known about SARS).
  • As has been reported in the media, 33.1% of the patients were non-Hispanic black, which is markedly higher than the 18% in the study catchment area. The rates for other ethnicities were: white 45% of COVID-19 hospitalized, 59% in catchment area; Hispanic 8% COVID-19 hospitalized, 14% catchment area.
  • Limitations of this report are preliminary data based on 12% of hospitalized patients in 14 states that comprise the COVID-NET group, much of the data is from early in the pandemic in the United States, and an ongoing issue of ethnicity/socioeconomic status and comorbid conditions (do the underlying diseases reflect the risk, or is the risk due to poor healthcare delivery in a population with these underlying diseases). It is important to stress that the numbers may change. There remain no data on non-hospitalized patients, so we don’t know if asthma is a risk for getting the virus or having more severe disease. As this surveillance system develops, we will continue to report the outcomes. At this point, all we can offer for advice is to state that U.S. data suggests that asthma may be a risk factor for hospitalization with COVID-19 and that you need to emphasize asthma control with your patients.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Wednesday, April 8, 2020

Before getting into the topic of today's Task Force message, we wanted to point out a new episode from the AAAAI's Conversations from the World of Allergy podcast series. It's titled How to Manage a Pollen Tsumani in the Midst of a Global Pandemic and features Anne Ellis, MD, FRCPC, FAAAAI, who discusses the management of spring pollen allergies and how this intersects with the current COVID-19 pandemic. Listen here and be sure to share it with your patients. A link to this new podcast episode has also been added to the AAAAI COVID-19 resources page.

Albuterol Shortage

  • The AAAAI was given a link to a database that was provided to all of the dozens of organizations that have participated in the Choosing Wisely campaign. Based on that database, the shortage is currently spotty and does not affect all albuterol inhalers. Please remember to reinforce control with your asthma patients and do not prescribe more than two albuterol inhalers at one time in most of your asthma patients, in order to prevent hoarding.

Treatment for COVID-19

  • Most allergists are not going to be involved in the inpatient treatment of patients with COVID-19 at this point, but they may have to provide medical advice to patients concerning therapy.
  • There has been a considerable amount of coverage in the lay and medical press about the use of chloroquine and hydroxychloroquine for treatment of COVID-19. There was an editorial published in the Annals of Internal Medicine with considerations as to why this may not be a good approach at the current time.
  • Even though this drug has shown promise in in-vitro studies on growth of SARS-CoV-2, it has been shown to have similar effects on influenza virus, but clinical trials on patients with influenza have not shown any benefit. In-vitro effects don’t always pan out in clinical trials.
  • Current retrospective, uncontrolled trials using hydroxychloroquine in patients with severe COVID-19 infection have been small, uncontrolled, and methodologically flawed.
  • Inappropriate use or hoarding of this drug for prevention or treatment has adverse consequences:
  1. Shortages for proven treatment for patients with autoimmune disease, especially SLE.
  2. Shortages for controlled clinical trials in patients with COVID-19.
  3. Inability to recruit patients for clinical trials because they feel they can get the drug for this purpose anyway.
  4. These drugs have the potential for serious adverse consequences.
  5. Some state medical and pharmacy boards are monitoring activity and will be penalizing physicians who prescribe hydoxychloroquine for themselves, family members, across state lines, or when clearly not indicated.
  • Other therapies being studied or considered. There are currently 366 clinical trials on the government website, most of which are for treatment of COVID-19, that are being done internationally. Candidate treatments being evaluated, in addition to the anti-malarials and azithromycin, include iron chelation, anti-virals, a variety of biologic agents, inhaled and systemic steroids, PDE inhibitors, ARBs, recombinant ACE2, anti-IL6 and other biologic agents directed against the inflammatory response, convalescent sera, hyperimmune globulin. Vaccine trials have started with several additional ones planned.

Medicare Telehealth Video

  • The Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network (MLN) has produced a nice YouTube video on the different telehealth/electronic/telephone services that are available for Medicare patients and coding that should be used. Access the video here.
  • Other useful links that have been provided in previous messages include this CMS fact sheet, which has a table summarizing the telehealth visits and requirements, and this CMS list of telehealth services. These have also been covered on the AAAAI COVID-19 advocacy page, as provided by Hart Health Strategies.

Keep regularly visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

williams-sig_1014239.png

Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, April 7, 2020

Before getting into the topic of today's Task Force message, we wanted to remind you that Hart Health Strategies continues to update the various documents that are listed at the AAAAI COVID-19 advocacy page. In fact, there is a new document with an implementation timeline for what's in the COVID-19 legislation packages. 

To help you know if you are accessing the most recent documents at our COVID-19 advocacy page, we’ve noted the date of the most recent version next to each link. If you are seeing a different date in the footer of the document, please clear your cache so your device downloads the current version. 

Allergist/immunologists should be aware of several themes circulating widely on social media that directly impact our patients. It is important for allergist/immunologists to be aware of these to help discuss with patients, anticipate their questions/confusion, and recognize that these may impair their medical decision making. Many of these sites and accounts look legitimate, but we also must recognize the ongoing widespread deliberate misinformation campaigns across the internet. While some of these recommendations may seem harmless, some can cause direct harm. More importantly, the sheer volume is distracting and dilutes the important public health messaging that we should all be promoting. Examples include:

False Medical Claims

  • Claims of supplements, vitamins, or foods that ‘boost immunity’ are rampant, including from medical professionals and large healthcare organizations.
  • Specific COVID-19 treatments (all unproven) are being touted or sold, including essential oils, supplements, colloidal silver, Vitamin C, elderberry, homeopathy, and chiropractic adjustments.
  • False claims of COVID-19 vaccines are being offered online.
  • Common themes include extrapolation of laboratory/animal data from small studies, pseudoscientific explanations and anecdotal reports.
  • Allergists can help patients by guiding them towards these simple fact-checking questions for any claim: What are the qualifications of the person making the claim? What does the body of evidence demonstrate for both benefits and risks? Is the person making the claim directly profiting from services or products? How can this apply to my specific situation, including factors pertaining to my medical history and possible interaction with medications or underlying conditions?

Asthma

  • While asthma is a widely heterogeneous condition with various levels of severity, risk, and control, asthma in general is listed as a risk factor for severe COVID-19 outcomes by the CDC and WHO. As allergists, we can help patients understand that data from China and Seattle both indicate that asthma was not a risk factor for patients with severe COVID-19 infections. We can also help patients understand the variation in asthma risk according to their personal history.
  • Early reports of systemic corticosteroids being associated with death from COVID-19 are being extrapolated to include ALL steroids as being dangerous. However, patients with asthma should be counseled that their inhaled corticosteroids are safe and necessary to continue to use in order to prevent exacerbation. They should also be aware that systemic corticosteroids can and should be used to treat an asthma exacerbation, even if it is caused by COVID-19.
  • Online discussion of nebulizers is causing confusion for some, as this is misconstrued to indicate that someone can catch COVID-19 from using a nebulizer. Allergists can help clarify and use clear language to inform patients that if they require treatment with nebulized medications, such as albuterol or atrovent due to asthma, they should start treatment early and repeat until better. COVID-19 does not ‘live’ inside nebulizers. However, if the person with asthma who is receiving nebulized treatment has COVID-19, they could spread to others in close proximity due to the respiratory droplets created through the nebulizer.

Cytokine Storm

  • Information is circulating online that patients with severe COVID-19 infection experience a cytokine storm.
  • This is being extrapolated as some to infer that anyone with underlying ‘inflammation’, including allergic conditions, is at risk to experience this cytokine storm if they become ill with COVID-19.
  • Allergists can reassure patients that there is no evidence to suggest their allergic rhinitis, atopic dermatitis, chronic urticaria, food allergies, history of anaphylaxis, etc., places them at risk for severe outcomes should they become sick with COVID-19.

Conspiracy Theories

  • This is a constant presence on social media and underlies many of the anti-vaccine and pseudoscientific claims online. The COVID-19 pandemic has amplified some of these fringe groups and some common themes have circulated, which may impair people’s judgement and affect their medical decision making.
  • Media hoax: This aligns with political ideologies and is leading many to continue to gather in large groups or disregard risk mitigation.
  • Doctors are lying: A campaign has been circulating where people drive to their local hospital and take pictures of empty parking lots or waiting rooms, then claim that there are no sick patients with COVID-19 and this is being falsely amplified.
  • Vaccine development/COVID-19 treatment: Concepts surrounding the need for clinical trials to demonstrate safety, efficacy, and dosing are challenging concepts for many. Policy makers and medical professionals are making recommendations to skip these necessary steps and start using various treatments, including hydroxychloroquine, on a widescale. Allergists are in a position to explain the necessary steps involved in drug and vaccine discovery to patients in an effort to help them understand timeline, expectations, and why some early claims will not pan out.

Supplies

  • Be careful about ads proliferating on social media and even by direct email, from alleged suppliers of PPE. Some of these are legitimate, some do provide the materials but at exorbitant costs, and some are outright scams that take your money but do not provide the goods.

We urge you to keep visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Monday, April 6, 2020

Recent news has covered concerns about testing for SARS-CoV-2, the virus that causes COVID-19. Recent reports question the accuracy of negative RT-PCR tests and the coming availability of serologic testing. The scientific representatives on the Task Force have prepared the following information:

Specific SARS-CoV-2 Testing (As of April 3, 2020)

The current standard for making the diagnosis of COVID-19 depends on identifying SARS-CoV-2 in respiratory secretions typically testing a swab sample from the nasal-pharynx or oral cavity. The testing method involves a reverse transcriptase (RT) polymerase chain reaction (PCR) to amplify the viral RNA for qualitative detection. Currently the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to more than 20 companies and commercial laboratories. In most cases the assay takes ~2 hours, but there are at least three more rapid testing systems that are approved as a point of care (POC) assay: Abbott ID Now COVID-19 (13 minutes), Mesa Biotech Accula SARS-CoV-2 test (30 minutes), Cepheid Xpert Xpress SARS-CoV-2 test (45 minutes) and there may be additional testing systems that provide rapid results with instruments that are consistent with POC testing. The FDA website has a list of all testing systems having received an EUA including information for healthcare providers regarding each of these.

According to the CDC, “a positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and the patient is presumptively infected with the virus” while “a negative result does not exclude the possibility of COVID-19.” The rate of false negative RT-PCR tests is not currently defined. Some of the factors that could contribute include testing sensitivity, timing and location of the sample, as well as other issues.

There is increasing interest in serologic/antibody testing for SARS-CoV-2 and at the present time there are a number of companies providing either a POC test or a laboratory-based immunoassay test for IgM and IgG to SARS-CoV-2. There is interest in POC testing kits for SARS-CoV-2 and currently these are available from diagnostic companies, including 20/20 Bioresponse, BD Biomedomics, Biomerica, Cellex, Sunscreen Diagnostics, plus the distributor Ideal Rehab Care, Inc. This is an incomplete list as there are likely other companies that either have received or will receive in the near future EUA approval by the FDA. These POC tests use a very small volume of whole blood or serum/plasma as the test sample and typically are done on a small cartridge/cassette with results in ~15 minutes. The validation of these various tests varies and often has been done in Asia where the earliest cases of COVID-19 occurred. The FDA authorization includes the disclaimer that the serologic test alone is not for primary diagnosis of COVID-19. The biggest issue to keep in mind with these POC serologic tests is sensitivity (that is true positives) and specificity (the true negatives) from which one can calculate the false negative and false positive rates.

Some of the challenges with interpreting these tests include:

  • Some conflicting data as to how quickly IgM develops relative to the onset of symptoms
  • What is the time-line for IgG production?
  • Ruling out cross reactivity with other strains of CoV that cause URIs

More data on the performance of serologic testing to SARS-CoV-2 is likely to be forthcoming.

At this point the Task Force is unable to make any recommendations as to the appropriate use for these tests, as more information is needed.

Keep visiting the AAAAI COVID-19 resources page for updated resources. If you need to refer back to any of the previous Task Force messages, you can do so here. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, April 3, 2020

We want to remind you that if you need to refer back to any of the previous Task Force messages, you can do so here.

Here are our updates for you today:

There are some clinical issues we would like to share concerning questions we have received. Answers to questions we have been fielding, that would be helpful for a wider audience to see, have been posted to the AAAAI COVID-19 resources page.

Asthma

  • There is no data to support the belief that asthma is a risk factor for COVID-19. Available data suggest that the rate of asthma in patients with severe COVID-19 is the same or lower than the general population.
  • Systemic steroids are not recommended for the treatment of COVID-19, but are okay for asthma exacerbation.
  • It is important to continue to manage your asthma patients and asthma exacerbations according to the guidelines. Focus on asthma control to keep our patients well and out of the emergency room (ER) and urgent care, where the risk for infection with COVID-19 is much higher. This would be a good time to ensure that all of your asthma patients are up to date on medications and treatment plans.
  • There is no evidence that the biologics we use in asthma have any adverse effect on COVID-19 cases, and it would be important to continue them based on the need for asthma control.
  • Steroid dependent asthmatics: Remember adjustments for adrenal insufficiency and severe infection, may need to consider stress doses of hydrocortisone even for patients on high dose ICS. See this article.

Food Allergies

  • Additional counseling for food allergy patients regarding the inability to choose more familiar foods or query waitpersons/chefs when getting restaurant take-out was posted in a previous message.
  • The white paper on COVID-19 and the allergist just published in JACI: In Practice recommends adjusting counseling about epinephrine use in the case of a reaction, emphasizing that transportation to the ER was for the allergic reaction itself and not for potential adverse reactions to epinephrine. If the patient has a mild allergic reaction, an ER trip may not be needed even if epinephrine was administered, in order to reduce the risk for COVID-19 infection.

Prescriptions

The CARES Act removed the requirement that OTC medications require a prescription to allow patients to use HSA or FSA funds to pay for them.

Small Business Loans, Paycheck Protection Program, Loan Forgiveness and Now Employee Retention Credit

  • If you are confused by all the small business resources out there, you are not alone. Visit this very helpful website for an overview and FAQs.
  • Hart Health Strategies continues to add helpful information on small business resources to the AAAAI COVID-19 advocacy page. Look for FAQs on the Paycheck Protection Program (PPP). Expect further guidance as the program rolls out, thus current information should be reviewed with caution. Small businesses can apply for the PPP loans beginning today, April 3, 2020. The sample application form can be found here. Businesses/practices should contact their lender to determine what additional information they require. According to the U.S. Treasury Department, borrowers may “apply through any existing SBA lender or through any federally insured depository institution, federally insured credit union, and Farm Credit System Institution that is participating. Other regulated lenders will be available to make these loans once they are approved and enrolled in the program. You should consult with your local lender as to whether it is participating. Visit SBA.gov for a list of SBA lenders.
  • Employee Retention Credit (Visit this website)
  1. Eligibility: 50% reduction in revenue compared to similar quarter in 2019.
  2. Talk with the SBA or your banker about using this credit and applying for loan forgiveness. You may not be able to do both.
  3. Credit: 50% of qualifying wages and some benefits paid up to $10,000 between March 12, 2020, and January 1, 2021.
  4. Immediate reimbursement: Employers can be immediately reimbursed for the credit by reducing their required deposits of payroll taxes that have been withheld from employees’ wages by the amount of the credit.

Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Wednesday, April 1, 2020

Here are our important updates for today:

Attend the Special COVID-19 Edition of Virtual Journal Club Tonight

Join JACI: In Practice and the New Allergist/Immunology Assembly tonight, Wednesday, April 1, at 8:30 pm EDT for a special Virtual Journal Club webinar, which will discuss two recently published COVID-19 papers: Telemedicine in the Era of COVID-19 and COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic. This one-hour webinar is free for members and non-members alike. You can register here.

Small Business Loan Program Expected to Be Up and Running by April 3

  • Businesses can go to participating lenders, banks, and credit unions to apply for a loan and be approved the same day.
  • Participating lenders should be listed on the Small Business Administration (SBA) website.
  • Contact your local banker for more details.
  • As there are different loans, some of them must be filed online.

New CMS Rules and Waivers

On March 30, the Centers for Medicare & Medicaid Services (CMS) issued a “wave” of new rules and regulations, most of which affect hospitals and large healthcare institutions caring for acutely ill COVID-19 patients, and most of which do not affect the typical practicing allergist. Many of these seem to be already in place. Below are some changes that might affect our members. As always, regulations and in-place changes may lag behind announcements.

  • Medicare will pay laboratory technicians to collect specimens at home for COVID-19 testing.
  • Efforts to rapidly expand the healthcare workforce
  • Hospitals can provide meals, laundry services and childcare for their staff.
  • Attendings can supervise residents virtually.
  • Waived requirements for a nurse to conduct an onsite visit every two weeks for home health
  • Removed barriers for hospitals to hire community and out of state practitioners
  • Promote telehealth in Medicare
  1. 80 additional services, including ER visits, can be provided by telehealth.
  2. If a physician determines that a Medicare beneficiary should not leave home because of a medical contraindication or due to suspected or confirmed COVID-19, they will be considered homebound and qualify for the Medicare Home Health Benefit.
  3. Virtual Check-In services can now be provided for both new and established patients.
  4. E/M selection can be based on MDM or time, requirements for history and/or PE in the EHR removed for duration of the PHE.
  5. Hospitals can support physician’s practices by transferring items for telehealth.
  6. States who have not yet applied for Medicare waivers do not need to do so with these blanket waivers (15 states have already been granted these waivers).

Billing for Professional Health Services During the Public Health Emergency

  • This guideline was released by CMS on March 31.
  • Traditional Medicare telehealth services professional claims should reflect the designated POS code 02-Telehealth, to indicate the billed service was furnished as a professional telehealth service from a distant site. There is no change to the facility/non-facility payment differential applied based on POS. Claims submitted with POS code 02 will continue to pay at the facility rate.

Remember to visit the AAAAI COVID-19 resources page, which is being updated often. If you need to refer back to any of the previous Task Force messages, you can do so here.

Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Tuesday, March 31, 2020

Here are the updates we have for you today:

Accelerated and Advanced Medicare Payment Program

  1. Have billed Medicare for claims within 180 days prior to the date of the request
  2. Not be in bankruptcy
  3. Not be under active medical review
  4. Not have any outstanding delinquent Medicare overpayments
  • Medicare will start accepting and processing the requests immediately.
  • Providers can request up to 100% of the Medicare payment amount for a three month period (based on prior three month periods of Medicare payments). A specific amount must be listed.
  • Request forms are available on your MAC’s website.
  • Payment will be issued by your MAC within seven days of receiving the request.
  • Repayment begins 120 days after receipt of issuance of payment, and must be complete by 210 days after issuance.
  • Regarding recoupment and reconciliation, the provider/supplier can continue to submit claims as usual after the issuance of the accelerated or advance payment; however, recoupment will not begin for 120 days. Providers/suppliers will receive full payments for their claims during the 120-day delay period. At the end of the 120-day period, the recoupment process will begin and every claim submitted by the provider/supplier will be offset from the new claims to repay the accelerated/advanced payment. Thus, instead of receiving payment for newly submitted claims, the provider’s/supplier’s outstanding accelerated/advance pay will be deducted from the new claims.

Updates to the SBA Emergency Loan and Paycheck Program from Hart Health Strategies

  • Loans have to be processed through Small Business Administration (SBA)-affiliated lenders. Currently the “find a lender” link on the SBA website is non-functional. It is likely to take the SBA a few days to update their information and application processes.
  • Contacting banks may be the best way, but they have to be an SBA lender.
  • The 100 most active lenders for SBA 7(a) loans from 2019 can be found here.
  • Because of the changes to the 7(a) loan process, it still may take a few days for banks to update their application processes.
  • Once the SBA has figured out the application process for the loan, then they have to issue guidance or regulation on the forgiveness within 30 days.
  • The forgiveness is only for an eight week period, beginning on the date of loan origination. You will need to be ready to move forward quickly once the processes are established. In order for the forgiveness to be complete, you may need to rehire any furloughed employees and that has to happen before the end of June.

DEA Changes

  • In response to the COVID-19 outbreak, the Drug Enforcement Administration (DEA) has made some changes in its allowances for prescribing controlled substances. Details may be noted here.

EoE/EGID and COVID-19 World-Wide Data Collection Resource

  • This platform has been developed to collect information on patients previously diagnosed with Eosinophilic Esophagitis (EoE) and Eosinophilic Gastrointestinal Diseases (EGID) who are under high suspicion or confirmed with a diagnosis of COVID-19.
  • We encourage practitioners world-wide to report ALL confirmed cases (including asymptomatic cases identified by through public health screening) and severe cases for whom COVID-19 has not been confirmed because of the lack of available testing (these will be listed as unconfirmed in the questionnaire).
  • This case report form should be completed after the patient has had COVID-19 for a long enough duration to experience partial or complete recovery, hospitalization, or death.
  • To report a case of COVID-19 in an EoE/EGID patient please follow this link.

IDF Survey Project

  • The Immune Deficiency Foundation (IDF) has launched a COVID-19 & PI survey project to collect data each week on issues affecting the PI community. This survey is for patients, asks basic questions and allows the ability to sign up for the larger, ongoing study. It will only be live until Thursday, April 2. Please tell your PI patients and pass on this link from the IDF website that describes how to access the survey.

Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the COVID-19 Response Task Force

 


Monday, March 30, 2020

Today's message from the AAAAI COVID-19 Response Task Force will focus on some advocacy updates and highlights from the CARES Act.

Advocacy

CARES Act (Also Known As H.R. 748)

  • There are many tax provisions for individual, joint and corporate filers in this bill to allow for increased deductions and delayed payments. Talk to your accountant!
  1. Certain payroll taxes deferred through 2020, will not become due until the end of 2021 (50%) and 2022 (50%).
  2. Any business that does not have a loan forgiven under the new Small Business Administration (SBA) Paycheck Protection Program (see below) is eligible for the payroll tax deferral.
  • A $100 billion fund, run through the Public Health and Social Services Emergency Fund, will cover non-reimbursable expenses attributed to COVID-19.
  1. Designed to be immediately responsive to needs. The Department of Health and Human Services (HHS) will release funds to healthcare entities on a rolling basis as qualified applications are received. The HHS Secretary still needs to release guidance on the application process.
  2. Non-reimbursable expenses include PPE or foregone revenue from cancelled procedures, such as skin tests, spirometry, etc.
  • Specific details about the 7(a) SBA Paycheck Protection Program can be found here
  1. $500 billion, 100% federally guaranteed loans to employers who maintain their payroll during this emergency, maximum $10 million – loans forgiven if payroll maintained.
  2. Apply to an SBA-approved lender for a loan up to 250% of average monthly payroll costs (from 2/15/19 to 6/30/19) to cover eight weeks of payroll, benefits, and other expenses like rent, mortgage, and utilities.
  3. Loan can be forgiven based on maintaining employee and salary levels.

- Amount forgiven is reduced in proportion to number of employees retained, if any wages are reduced by more than 25%.

- This reduction will not apply if you rehire employees previously laid off or resume prior wages by June 30, 2020.
- For any portion of the loan not forgiven, payback terms include maximum term of 10 years and maximum interest rate of 4%.
- Available through June 30, 2020.

  • There is an employee retention tax credit for businesses that are not eligible or choose not to participate in the SBA Paycheck Protection Program.
  1. Any business forced to fully or partially suspend operations, or that has seen a significant drop in revenues are eligible for 50% credit for wages paid to furloughed or reduced-hour employees.
  2. For businesses with 100 employees or less, credit is based on all wages paid, regardless of whether the employee is furloughed.
  3. Can be claimed against the business quarterly payroll tax liability and is fully refundable to the extent of excess. Check IRS.gov and talk to your payroll service provider.
  • $17 billion for immediate relief to small businesses with non-disaster SBA loans. SBA will cover all loan payments for six months.
  • SBA Economic Injury Emergency Grant Program: Emergency advance of up to $10,000 to small businesses and private non-profits within three days of applying for an SBA Economic Injury Disaster Loan (which was discussed in a previous message). Ask for it when you apply for the loan – does not need to be repaid.
  • Medicare patients can fill up to 90 days of medications if prescribed.
  • Unemployment Insurance
  1. An additional $600 added to every check between now and July 31. Expands insurance to individuals who are not traditionally covered, including self-insured, and independent contractors. Contact your state unemployment office.
  2. Eligible for an additional 13 weeks of benefits if you have already exhausted your benefits.
  3. There are incentives for states to waive the waiting week.
  • Emergency Leave Provisions Changed
  1. With respect to the paid sick and family leave discussed in our last message, as provided by the Family Coronavirus Recovery Act, the CARES Act made some changes, including allowing the Secretary of Labor to exempt employers with fewer than 50 employees from the requirement to provide paid leave for childcare due to closures of schools and daycare. Additionally, employers of healthcare providers have the authority to unilaterally exclude their employees from all of the paid sick leave and family leave requirements.
  • Higher Education
  1. $13.9 billion Higher Education Emergency Relief Fund to support students and colleges/universities. Most will go to public institutions.
  2. Federal student loan borrowers do not need to make payments through September 30, 2020, and interest does not accrue.
  • Child Care
  1. States can use their funding through the Child Care and Development Block Grant to provide child care assistance to healthcare sector employees.

Your feedback makes our resources even better. Please continue to send your COVID-19 or any other comments and questions to practicematters@aaaai.org.

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Friday, March 27, 2020

Today’s message from the AAAAI COVID-19 Response Task Force will focus on resources for small businesses during this outbreak, as well as highlights from COVID-19 legislation passed by Congress. You can learn more at the AAAAI COVID-19 Advocacy page, under the heading Small Business Resources.

We also want to remind you to join JACI: In Practice and the New Allergist/Immunology Assembly on Wednesday, April 1 at 8:30 pm EDT for a special Virtual Journal Club webinar, which will discuss two recently published COVID-19 papers: Telemedicine in the Era of COVID-19 and COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic. This one-hour webinar is free for members and non-members alike. You can find the link to register on this page.

What We Need to Do as Employers

  • We all know that we want our employees who are sick to stay home. To accomplish this, be flexible about sick leave policies for employees who are sick or who have family members at home. The Centers for Disease Control and Prevention has guidelines for how to deal with sick employees.
  • Familiarize yourself with the “return to work” criteria and make sure the employee knows as well.
  • Make sure that contracted companies like janitorial and temp employees also understand about the importance of sick employees.
  • Cross-train employees to prepare for increased absenteeism.
  • Establish policies and practices for “social distancing” in the workplace.
  • Establish new policies for routine and enhanced cleaning of the workplace.
  • Discourage employees from using other workers' phones or equipment when possible. If not possible, clean and disinfect them before and after use.
  • Check with your insurance broker to see if you have business interruption coverage, and find out what the details of coverage are.
  • Communicate with your patients about changes.

Food Allergy Patients

  • Additional counseling may be needed for your food allergy patients, especially as the United States moves to grocery and restaurant pick-up service, and patients aren’t able to pick and choose their favorites or query wait staff or chefs.

Economic Injury Disaster Loans

  • The Small Business Administration (SBA) has set up a webpage. You can actually apply for loans from this webpage.
  • The SBA will work with state governors to provide small businesses with working capital loans of up to $2 million at low interest rates (3.75%).
  • Long-term repayment plans up to 30 years are available.
  • Loans can be used to pay fixed debts (rent, lease), payroll, accounts payable, and other bills.
  • For additional information, contact the SBA Disaster Assistance Customer Service Center at 1-800-659-2955 or email them at disastercustomerservice@sba.gov.

Family First Coronavirus Response Act

  • This is also known as the Phase II package or H.R. 6201. It applies to employers with fewer than 500 employees and is effective April 3, 2020.
  • Includes two weeks paid sick leave for full-time covered employees for COVID-19-related quarantine, symptoms, an ill family member with COVID-19, or for provision of childcare.
  • Includes 10 weeks of paid family and medical leave for employees (employed at least 30 days) who are unable to work due to childcare needs if schools or childcare facilities are closed.
  • Covers regular rate of pay (cap $511/day) for quarantine or symptoms of employee, or two-thirds regular rate (cap $200/day) for family or childcare.
  • Refundable payroll tax credit will reimburse businesses for sick leave, or family and medical leave wages paid to employees affected by COVID-19.
  • If you can’t afford the employee costs associated with such paid leave, the Treasury Department has stated that it will use its regulatory authority to advance funds to employers concerned about cash flow.
  • Employers must provide employees notice of eligibility for paid sick leave and family and medical leave. The Department of Labor is supposed to provide a model notification.
  • Be aware there are special rules for part-time employees and those who are self-employed.

Academic Institutions

  • The Accreditation Council for Graduate Medical Education has provided guidance to academic teaching centers regarding graduate medical education (GME) requirements. It allows institutions to declare pandemic emergencies and suspend all GME requirements, if needed.
  • The American Board of Allergy and Immunology and training programs are considering ways to compensate for lost teaching time for fellows-in-training.

 

Sincerely,

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Paul V. Williams, MD, FAAAAI
Chair of the AAAAI COVID-19 Response Task Force


Thursday, March 26, 2020

How do these emergency declarations affect the allergist/immunologist? Here are some highlights. To learn more visit the AAAAI COVID-19 resources page and remember to bookmark the page and check it often.

Federal Guidelines/Legislation
Although details are changing daily, these declarations allow the Department of Health and Human Services to:

  • adjust Medicare reimbursement for certain Part B drugs
  • modify the practice of telemedicine (see below)
  • provide financial and other assistance to state and local governments to respond to the pandemic
  • modify/waive certain conditions on participation in Medicare and Medicaid, sanctions related to the Stark law, and sanctions and penalties related to HIPAA privacy regulations.

The Family First Coronavirus Act included provisions to extend coverage without cost sharing f