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Coronavirus Disease 2019 (COVID-19) updates
Actions by 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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 COVID-19 vaccine updates
FDA to hold advisory committee meeting to discuss Pfizer-BioNTech's application for COVID-19 booster
September 17, 2021, 8:30 a.m. - 3:45 p.m. ET
FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.
 Are you ready for emergencies?
September is National Preparedness Month. Planning for hurricane season and other potential disasters can be stressful, and because the 2021 hurricane season comes during the COVID-19 pandemic, it may be especially so. Learn what you can do now to be ready.
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Emergency Use Authorization (EUA) updates
Resumption in use and distribution of bamlanivimab/etesevimab in all U.S. states, territories, and jurisdictions
HHS/ASPR and FDA announced that bamlanivimab and etesevimab, administered together, can now be used in all U.S. states, territories, and jurisdictions under the conditions of authorization for EUA 094 (PDF).
FDA has updated the list of states, territories, and U.S. jurisdictions (PDF) in which bamlanivimab and etesevimab administered together are currently authorized. ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available.(September 2, 2021)
In vitro diagnostic (test) EUAs
As of September 7, 2021, 409 tests and sample collection devices are authorized by FDA under EUAs. These include 287 molecular tests and sample collection devices, 88 antibody and other immune response tests, and 34 antigen tests. There are 62 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 7 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 14 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 622 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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September 8, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host an additional webinar in this series on September 22, 2021.
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September 9, 2021: Authorities Associated with Respiratory Protection - The Role of NIOSH, the FDA, and OSHA , 3:00 - 4:00 p.m. ET - The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL), is hosting a webinar to clarify information regarding U.S. Respiratory Protection authorities, as part of Respiratory Protection Week. Speakers from NIOSH, FDA, and OSHA will discuss the roles of these agencies during conventional operations and emergency response scenarios, and how the respiratory protection landscape has evolved over the last year.
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September 9, 2021: FDA Grand Rounds - Immune System Responses to Therapeutic Proteins: Getting Up Close and Personal (webcast), 12:00 - 1:00 p.m. ET
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New! September 17, 2021: Vaccines and Related Biological Products Advisory Committee (8:30 a.m. - 3:45 p.m. ET, virtual) - To discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older. The meeting will be livestreamed.
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September 20-21, 2021: Pharmacodynamic Biomarkers for Biosimilar Development and Approval public workshop, hosted by FDA and Duke-Margolis, 10:00 a.m. - 2:30 p.m. ET both days - advance registration required
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September 30, 2021: The Vaccines and Related Biological Products Advisory Committee will meet in open session (8:30 a.m. - 3:40 p.m. ET, virtual) to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, and the Center for Biologics Evaluation and Research (CBER), and to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.
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New! October 4-6, 2021: 11th Annual Global Summit on Regulatory Science, hosted by FDA's National Center for Toxicological Research - This year's theme is Regulatory Sciences for Food/Drug Safety with Real-World Data & Artificial Intelligence (AI).
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New! October 5, 2021: Enhanced Drug Distribution Security in 2023 Under the DSCSA webinar, 1:00 - 2:00 p.m. ET - To discuss enhanced drug distribution security requirements that go into effect in 2023 under the Drug Supply Chain Security Act (DSCSA), including how enhanced drug distribution security will help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
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Information for industry and health care providers
Reminder for veterinarians and retailers of animal health products
We are asking for your help in sharing important safety information about the misuse of animal ivermectin to prevent or treat COVID-19 in people. To assist you, we have developed a sign that is available for download (PDF) if you’d like to pass it out or post it at your place of business to remind people about the dangers of treating themselves with animal ivermectin. (August 30, 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
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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50 years of scientific achievements
FDA's National Center for Toxicological Research (NCTR) is celebrating 50 years of scientific achievements. NCTR scientists developed a method to detect the virus that causes COVID-19 in wastewater, yielding important data to support the COVID-19 response.
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FDA Medical Countermeasures Initiative (MCMi) News)
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