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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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FDA authorizes new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
FDA issued an EUA (PDF) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. The authorization also requires that individuals either have:
- moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers (PDF)) or;
- a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
“Vaccines have proven to be the best defense available against COVID-19. However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals.” Also see: Frequently Asked Questions on the Emergency Use Authorization for Evusheld (PDF) (December 8, 2021)
On December 10, 2021, FDA reissued the EUA (PDF) for Evusheld to add a new limitation detailing the scope of health care providers who are authorized to prescribe Evusheld for use under this EUA. An additional condition requiring AstraZeneca to genotype and phenotype virus isolated from prophylaxis failures was also added.
COVID-19 vaccine updates
 FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds
FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. (December 9, 2021)
Janssen COVID-19 fact sheets updated
FDA is announcing revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) (PDF) and the Fact Sheet for Recipients and Caregivers (PDF). The fact sheets will now include a contraindication to the administration of the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine, and to update the information about the risk of thrombosis with thrombocytopenia syndrome or TTS following vaccination.
Cases of TTS following administration of the Janssen COVID-19 Vaccine have been reported in males and females 18 years of age and older, with the highest reporting rate of approximately 1 (one) case per 100,000 doses administered in females 30-49 years of age; overall, approximately 1 out of 7 cases has been fatal. The FDA and CDC continue to investigate the level of potential excess risk.
The FDA continues to find that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. Individuals should speak to their health care provider to determine which COVID-19 vaccine is most appropriate for their own situation. (December 14, 2021)
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Emergency Use Authorization (EUA) updates
Moderna COVID-19 Vaccine EUA amendment
FDA issued a granting letter (PDF) to amend the Moderna COVID-19 Vaccine EUA to update the authorized EUA fact sheets for health care providers and recipients and caregivers. (December 9, 2021)
EUA revocations
On December 8, 2021, FDA revoked EUAs for three tests that are no longer being used:
- BMC-CReM COVID-19 Test (Boston Medical Center)
- Akron Children's Hospital SARS-CoV-2 Assay (Akron Children’s Hospital)
- BioGX SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company (BD))
On December 10, 2021, FDA revoked one EUA for a test that is no longer being used:
- qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc.)
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information.
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
In vitro diagnostic (test) EUAs
As of December 14, 2021, 421 tests and sample collection devices are authorized by FDA under EUAs. These include 291 molecular tests and sample collection devices, 89 antibody and other immune response tests, and 41 antigen tests. There are 67 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 22 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 707 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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Information for industry and health care providers
3D printing of medical devices at the point of care
FDA posted a discussion paper on 3D Printing Medical Devices at the Point of Care (PoC). The discussion paper provides background information on 3D printing and potential PoC manufacturing scenarios for public comment. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development. The discussion paper:
- Provides relevant background, including terminology, brief overview of the FDA regulation of devices and 3D printing, and how capabilities at a 3D printing facility factor into device safety and effectiveness.
- Identifies challenges presented by 3D printed medical devices at the PoC and presents a potential approach for regulatory oversight under various scenarios to inform future policy development.
- Poses questions to facilitate public comment.
FDA is seeking input on each of these topics and on 16 questions posed in the discussion paper. This discussion paper will be open for public comment for 60 days at: https://www.regulations.gov/docket/FDA-2021-N-1272. (December 10, 2021)
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Draft guidance: Real-world data
FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. The guidance discusses the applicability of FDA's investigational new drug (IND) application regulations under 21 CFR part 312 to clinical study designs that use real-world data (RWD) and clarifies the agency's expectations for sponsors submitting new drug applications or biologics license applications using RWD to support the safety or effectiveness of a drug in clinical studies that are not subject to 21 CFR part 312. Submit comments by March 9, 2022. (December 9, 2021)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.
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Why you should not use ivermectin to treat or prevent COVID-19
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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