- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- In mid-July, the FDA held a stakeholder call to discuss COVID-19 vaccines, including preliminary reports of Guillain-Barré Syndrome following Janssen (Johnson & Johnson) COVID-19 vaccination. Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. were featured speakers. The call can be found on the FDA’s YouTube page.
- Testing updates:
- As of today, 398 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 279 molecular tests and sample collection devices, 87 antibody and other immune response tests and 32 antigen tests. There are 53 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, six antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 13 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 595 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Veronika Pfaeffle