| Coronavirus Disease 2019 (COVID-19) updates Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi 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. | | Emergency Use Authorization (EUA) updates Revoked COVID-19 in vitro diagnostic EUAs These EUA revocations were requested by the manufacturers of the devices. - Guardant-19, Guardant Health Inc. - revoked (PDF) August 6, 2021
- MatMaCorp COVID-19 2SF Test, Materials and Machines Corporation of America (DBA MatMaCorp, Inc.) - revoked (PDF) August 3, 2021
In vitro diagnostic (test) EUAs As of August 17, 2021, 402 tests and sample collection devices are authorized by FDA under EUAs. These include 282 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 33 antigen tests. There are 56 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 6 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 13 antigen tests and 8 molecular tests for serial screening programs. The FDA has also revised 605 test EUAs. Also see: Coronavirus Testing Basics | | | 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)
- 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
| | Information for industry Submit 506J notifications to FDA using new web form FDA is providing an online form to assist manufacturers in submitting 506J notifications. Under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing during or in advance of a public health emergency.
The online form is intended to further assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical devices that could help the FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency. The form includes options to: - Submit notifications directly into the form,
- Submit larger numbers of notifications using a spreadsheet template,
- Voluntarily notify the FDA that you are not experiencing an interruption or discontinuance.
See Contact the FDA about a Medical Device Supply Chain Issue for additional information about submitting 506J notifications. (August 3, 2021) 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 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. | Did someone forward you this email? Subscribe. (Select Emergency Preparedness and Response, FDA Medical Countermeasures Initiative (MCMi) News)
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