FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age | Join EMA & FDA for a Dec. 15 mAb workshop

U.S. Food and Drug Administration sent this bulletin at 12/14/2022 08:05 AM EST

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The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include:

December 13, 2022: FDA Roundup including an update to the device shortages list to remove medical gloves
December 13, 2022: Consumer Update: Protect Your Family From Fraudulent Flu Products
December 9, 2022: FDA Roundup including an EUA for the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit, a test kit supported by the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA)
December 8, 2022: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age
December 8, 2022: Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA
December 8, 2022: Voluntary Recall of Three Detect Covid-19 Test Lots (company announcement) - There is an increased chance that the tests from certain lot numbers may give false negative results.

Quick links: COVID-19 updates from FDA, FDA Mpox Response

COVID-19 vaccine updates

FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age

FDA amended the Emergency Use Authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. (December 8, 2022)

More information, including updated fact sheets and regulatory documentation, and new Dear Health Care Provider letters is available at:

Read the press release

Emergency Use Authorization (EUA) updates

**COVID-19 in vitro diagnostic (test) EUAs**

As of December 13, 2022, 440 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, 55 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 39 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,172 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics

Events

December 14, 2022: 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.
New! December 15, 2022: Workshop: Efficacy of Monoclonal Antibodies in the Context of Rapidly Evolving SARS-CoV-2 Variants (7:00 - 11:00 a.m. ET, virtual) - Hosted by FDA and the European Medicines Agency (EMA) to bring together scientists, clinicians, industry representatives and regulators to discuss alternative strategies to support the development of novel monoclonal antibody therapies including those based on prototype products that have demonstrated safety and efficacy in clinical trials. This meeting is intended for experts in the field and/or people actively involved in the topic of the meeting. Please register in advance.
December 16, 2022: Machine Learning in Distributed Data Networks like the FDA Sentinel System: Opportunities, Challenges, and Considerations (12:30 - 1:30 p.m. ET, virtual)

Information for industry and health care providers

Medical device shortages during COVID-19

FDA updated the device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC). FDA will continue to monitor the supply chain and update the device shortage list and device discontinuance list as new information becomes available. (December 12, 2022) Also see: Medical Gloves for COVID-19

Update: SARS-CoV-2 viral mutations: Impact on COVID-19 tests

FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add Luminostics, Inc. Clip COVID Rapid Antigen Test as a test expected to have reduced performance for the SARS-CoV-2 omicron variant and sub-variants. (December 13, 2022)

Dewei Medical Equipment Co. recalls DNA/RNA Preservation Kits that are not authorized, cleared, or approved by the FDA

Dewei Medical Equipment Co. is recalling DNA/RNA Preservation Kits because these products were distributed to U.S. customers without authorization, clearance, or approval from the FDA. This means there is a risk for false negative, false positive, or misinterpretation of results if these products are used to detect SARS-CoV-2. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. (December 8, 2022)

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.

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.

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!)

Expiration date extensions of COVID-19 at-home tests
Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.

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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