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COVID-19 vaccine updates
Advanced manufacturing update
OCET Advanced Manufacturing Program
Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. The OCET Advanced Manufacturing Program aims to help FDA develop regulatory science tools and metrics, and facilitate industry adoption of these emerging technologies—especially to improve public health emergency response and supply chain resilience.
The Office of Counterterrorism and Emerging Threats (OCET), in the Office of the Chief Scientist, published a new website section with additional information about its advanced manufacturing program, including new pages about the I-TEAM Hub collaboration with HHS/ASPR, a smart design and manufacturing pilot program, and a partnership with the National Institute of Standards and Technology (NIST) to develop and benchmark methods to predict thermal stability of monoclonal antibodies. The section also includes new pages about advanced manufacturing research and projects, and public-private partnerships. The existing Advanced Manufacturing page will continue to include advanced manufacturing news, events, and funding opportunities from across FDA. (November 21, 2022)
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 Regulatory science funding
FDA Broad Agency Announcement (BAA) Day agenda now available
On November 14, 2022, FDA posted the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. For more information and areas of interest, including medical countermeasures and advanced manufacturing, see the full BAA PDF (788 KB).
We invite interested applicants to join us for FDA BAA Day on December 6, 2022, to learn more about the application process. A draft agenda is now available.
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Emergency Use Authorization (EUA) updates
Updated web pages: COVID-19 antigen tests EUA revision for repeat testing
On November 1, 2022, FDA revised the EUAs of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat, or serial, testing. See these web pages (updated November 17, 2022) for more:
New EUAs: OTC COVID-19 antigen tests
On November 17, 2022, FDA issued EUAs for two over-the-counter (OTC) antigen diagnostic tests that show results in 15 minutes: the Hotgen COVID-19 Antigen Home Test (PDF) and the NIDS COVID-19 Antigen Home Test (PDF).
Both tests can be used as a serial test for people within the first 7 days of experiencing COVID-19 symptoms or for individuals without symptoms. The tests should be repeated if a negative result is found – at least twice over 3 days with at least 48 hours between tests if the individual has symptoms, or at least 3 times over 5 days with at least 48 hours between tests if the individual does not have symptoms. The tests can be used for people age 14 years or older with a self-collected nasal swab sample and age 2 years or older when an adult collects the nasal swab sample.
Validation data for the NIDS COVID-19 Antigen Home Test were gathered through the FDA’s collaboration with the National Institutes of Health Independent Test Assessment Program (ITAP).
COVID-19 in vitro diagnostic (test) EUAs
As of November 18, 2022, 437 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,161 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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November 30, 2022: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) (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. FDA will hold an additional event in this series on December 14, 2022.
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December 6, 2022: Register now for FDA Broad Agency Announcement Day (webinar) to learn more about how FDA funds research, the types of projects we’re looking for to support regulatory science and innovation, and how you can apply.
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December 7-8, 2022: FDA Clinical Investigator Training Course (CITC) 2022 (webinar) - To promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
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December 7-8, 2022: The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023 (virtual public workshop) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share their perspectives on DSCSA implementation.
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December 8, 2022: Blood Products Advisory Committee meeting (virtual) - The committee will meet in open session to hear an overview of the research programs of the Laboratory of Emerging Pathogens and the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research.
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New! 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)
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Information for industry and health care providers
Data points on the bivalent COVID-19 vaccination
The bivalent vaccines provide preventative protection against COVID-19. Both Pfizer-BioNTech and Moderna have now reported safety and immune response data for their updated bivalent mRNA vaccines. These data may be helpful as you have discussions with your patients. View the new printable fact sheet (PDF).
Update on Philips Respironics Recall: New Issues Identified in Reworked Trilogy Ventilators
Philips has informed FDA that the Philips Respironics Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues. FDA has requested additional information from Philips to better understand the cause of the issues and to provide informed recommendations to patients, caregivers, and health care professionals. (November 17, 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.
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In case you missed it
Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you.
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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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FDA Medical Countermeasures Initiative (MCMi) News)
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