| Coronavirus Disease 2019 (COVID-19) updates  Updates from 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. | | | COVID-19 vaccine updates FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age  On June 17, 2022, FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. For the Moderna COVID-19 Vaccine, the FDA amended the Emergency Use Authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. A recording of the June 17, 2022, press conference is available on YouTube (32 minutes). Vaccine providers: Also see Information for industry and health care providers below. | VRBPAC meeting: June 28, 2022 Watch live, 8:30 a.m. - 5:00 p.m. ET The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet virtually to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.  Some perspectives on data science and coronaviruses FDA Grand Rounds - recording now available On June 9, 2022, Seshadri S. Vasan from CSIRO, Australia's science agency, presented an FDA Grand Rounds presentation, including updates on some FDA-funded research. A recording of this lecture is now available (1 hour). | | | Emergency Use Authorization (EUA) updates  In vitro diagnostic (test) EUAs As of June 21, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,005 revisions to test EUAs. Also see: COVID-19 Test Basics | | |  Events - June 28, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. ET) - To discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. Watch live.
- June 28, 2022: FDA Drug Topics: Drug Shortages: Root Causes and Potential Solutions webinar - This webinar will provide a general overview of CDER's Drug Shortages program, current shortage issues, and challenges.
- June 29, 2022: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:05 - 1:00 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series in 2022.
- July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility. Registration is now open for in-person and virtual attendance. Please pre-register by June 30, 2022.
- New! July 14, 2022: FDA Grand Rounds: One Health at FDA: From Concept to Application, 12:00 - 1:00 p.m. ET, presented by CAPT Brianna Skinner, DVM, MPH, DACLAM, of FDA's Office of Counterterrorism and Emerging Threats (OCET) and Annamaria Castiglia, DVM, of FDA's Center for Veterinary Medicine (CVM).
| | Information for industry and health care providers Information for health care providers about the authorization of Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age As noted above, on June 17, 2022, FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. New and updated materials for health care providers include: Moderna COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine Additional information, including information about FDA's evaluation of safety and effectiveness, and ongoing safety monitoring, can be found in the press release. 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  Resources to keep yourself and others safe from COVID-19
Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.) |  List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 300 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. | Did someone forward you this email? Subscribe.
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