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COVID-19 test updates
Understanding at-home OTC COVID-19 antigen diagnostic test results
FDA is providing an easy step-by-step guide to help you decide when and how many times to test for COVID-19, what your test results mean, and what you should do next. FDA-authorized over-the-counter (OTC) at-home COVID-19 tests for self-testing at home or other locations are a fast and convenient COVID-19 testing option. With the holiday season upon us and many indoor gatherings taking place, we hope this information will help guide you and your families through a safe and healthy holiday and beyond, especially with other respiratory infections circulating, including flu and RSV. |
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COVID-19 vaccine updates
FDA announces vaccine advisory committee meeting on future of COVID-19 vaccines
On January 26, 2023, FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward. (December 16, 2022)
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ICYMI - Bivalent vaccines authorized for children down to 6 months of age
On December 8, 2022, FDA amended the EUAs of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. View the pages below for more information, including updated fact sheets and regulatory documentation, and new Dear Health Care Provider letters.
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Emergency Use Authorization (EUA) updates
mpox: New EUA for molecular diagnostic test
FDA issued an EUA (PDF) to Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) for the TaqPath Monkeypox/Orthopox Virus DNA Kit, fpr qualitative detection of DNA from monkeypox (mpox) virus (clade I/II) in human lesion swab specimens from individuals suspected of mpox by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests. (December 13, 2022)
EUA revocations
FDA revoked EUAs for these tests for the reasons noted in the revocation letters:
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.
COVID-19 in vitro diagnostic (test) EUAs
As of December 20, 2022, 441 tests and sample collection devices are authorized by FDA under EUAs. These include 298 molecular tests and sample collection devices, 86 antibody and other immune response tests, 56 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 23 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 40 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,184 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Broad Agency Announcement funding reminder
Events
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January 11, 2023: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov.
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New! January 12, 2023: Virtual Public Listening Session to Identify Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology (webinar, 1:00 p.m. ET) Also see: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology
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New! January 26, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19, including consideration of the composition and schedule of the primary series and booster vaccinations.
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April 24–27, 2023: 2023 Preparedness Summit - Recover. Renew: Reprioritizing All-Hazards Preparedness (Atlanta, GA) - Registration is now open, including virtual options.
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Information for industry and health care providers
Reminder: Influenza antiviral shelf-life extensions (Tamiflu and Relenza)
in April 2022, HHS issued a message (PDF) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product.
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Tamiflu 30mg, 45mg, and 75mg capsules: Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 30mg, 45mg, and 75mg capsules held in strategic stockpiles to be used for a maximum of 20 years beyond their date of manufacture. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Tamiflu capsules, provided that the products have been stored under labeled storage conditions. This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir.
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Relenza inhalation powder (reminder of previous extension): Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. No further extensions are anticipated beyond 10 years.
FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. However, stakeholders that apply this extension to their stockpiled products should clearly note in their stockpiles that FDA has allowed for its extension (e.g., by placing a placard on the outside of a pallet or shipping box). In addition, if extended Tamiflu or Relenza product is dispensed during an influenza emergency response, stakeholders should inform health care providers and recipients about this product’s expiration dating extension.
States may contact their MCM Specialist or email preparedness@cdc.gov or sns.ops@cdc.gov to confirm the new extended dates for their antiviral drug inventories eligible for extension. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date.
Draft guidance update: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
On December 16, 2022, FDA’s Center for Veterinary Medicine released a draft update to guidance for industry (GFI) #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern. The guidance is a tool for assessing the risk of antimicrobial resistance (AMR) in people, which could result from the use of a medically important antimicrobial drug in food-producing animals. The scope and purpose of updated GFI #152 remains the same as the initial version of the guidance issued in 2003, but updates better align with current science and clinical practices in human medicine. The agency will be accepting public comments on the draft guidance until March 20, 2023.
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
Apply to become FDA’s next CERSI partner
FDA is seeking applications for Centers of Excellence in Regulatory Science and Innovation (CERSIs), to conduct collaborative regulatory science research and foster information sharing. Applications are due by December 22, 2022.
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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. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 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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Schedule note: This newsletter will return in January 2023. Happy holidays!
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FDA Medical Countermeasures Initiative (MCMi) News)
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