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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 authorizes booster dose of Pfizer-BioNTech COVID-19 Vaccine for certain populations
On September 22, 2021, FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:
- individuals 65 years of age and older;
- individuals 18 through 64 years of age at high risk of severe COVID-19; and
- individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
This authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine.
 It’s a good time to get your flu vaccine
While the U.S. remains focused on the COVID-19 pandemic, we need to also be aware of flu season as we approach winter. 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.
Tip: If you need both, you can get a COVID-19 vaccine and a flu vaccine at the same time.
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Emergency Use Authorization (EUA) updates
FDA takes new action to help ensure the performance of COVID-19 tests
FDA took additional steps to help ensure that the performance of authorized COVID-19 tests is not impacted by emerging SARS-CoV-2 viral mutations. FDA revised the authorizations of certain molecular, antigen, and serological tests for COVID-19 by requiring additional conditions of authorization concerning viral mutations.
The Viral Mutation Revision:
- Applies to most authorized SARS-CoV-2 molecular, antigen, and serology tests.
- Requires developers of tests that are within the scope of this revision to monitor emerging viral mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.
- Also requires such test developers to update the test labeling and communicate potential risks with the test’s intended users consistent with the letter.
FDA will continue to share updates as new information becomes available. If you have questions about the amendment, email COVID19Dx@fda.hhs.gov. (September 23, 2021)
In vitro diagnostic (test) EUAs
As of September 28, 2021, 410 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 35 antigen tests. There are 63 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 16 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 640 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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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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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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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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October 6, 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). An additional webinar in this series will be held on October 20, 2021.
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Information for industry and health care providers
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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Learn more about COVID-19 vaccines
Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you. Learn about the evidence supporting FDA approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines.
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