Coronavirus Disease 2019 (COVID-19) updates Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: - August 13, 2021: COVID-19 Update including a new FDA Consumer Update highlighting 5 Things to Know about COVID-19 Vaccination for Adolescents
- August 13, 2021: Preparing for the School Year: Younger Children & Adolescent Vaccine Updates - 45-minute recording of a stakeholder call with HHS Assistant Secretary for Health Rachel L. Levine, MD, and FDA Center for Biologics Evaluation and Research Director Peter Marks, MD, PhD
- August 12, 2021: FDA Authorizes Additional Vaccine Dose for Immunocompromised People
- August 6, 2021: COVID-19 Update including that FDA has found certain lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccine made from the lots, will now be exported for use.
Bookmark www.fda.gov/coronavirus for the latest. | COVID-19 vaccine updates 5 things you need to know about the COVID-19 vaccine for adolescents 12 through 17 This back-to-school season parents have questions about COVID-19 vaccination for kids 12 and older. Get answers from the FDA. Vaccination is one of the best ways to protect everyone 12 and older from COVID-19. Video frequently asked questions FDA vaccine expert, Dr. Peter Marks, participated in the HHS Ask An Expert video series to answer some of your most frequently asked questions about COVID-19 vaccination. Hear answers to these questions from Dr. Marks: - What are the ingredients in the COVID vaccines?
- Should I wait to get a COVID vaccine?
- Do the COVID vaccines cause long-term health problems?
- Are there people who are eligible but shouldn't get a COVID-19 vaccine?
FDA authorizes additional vaccine dose for certain immunocompromised individuals On August 12, 2021, FDA amended the Emergency Use Authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Other fully vaccinated individuals do not need an additional vaccine dose right now. Upcoming events -
August 18, 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). FDA will host additional webinars in this series each Wednesday in August.
- August 25, 2021: Manufacturing, Supply Chain, and Inspections during the COVID-19 Public Health Emergency webinar, 9:00 a.m. - 1:00 p.m. ET, hosted by FDA's Center for Drug Evaluation and Research (CDER)
- August 30 - September 1, 2021: Science and Regulation of Bacteriophage Therapy public workshop, hosted by FDA CBER and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID)
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New! September 1-2, 2021: FDA-M CERSI: Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design Public Workshop, hosted by FDA's Division of Pediatrics and Maternal Health and Complex Innovative Trial Design Pilot Meeting Program in CDER and The University of Maryland CERSI -
September 20-21, 2021: Pharmacodynamic Biomarkers for Biosimilar Development and Approval public workshop, hosted by FDA and Duke-Margolis, 10:00 a.m. - 2:30 p.m. ET both days - advance registration required In case you missed it 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. | | | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity |
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