- 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:
- On Thursday, June 29, 2021, 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., discussed the updates on myocarditis and pericarditis following vaccination with the Pfizer-BioNTech or Moderna COVID-19 Vaccines during a stakeholder call with Vaccinate Your Family and pediatric and healthcare groups. To watch and listen to the call, visit FDA’s YouTube channel.
- Testing updates:
- As of today, 393 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 281 molecular tests and sample collection devices, 84 antibody and other immune response tests and 28 antigen tests. There are 52 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, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 11 antigen tests and three molecular tests for serial screening programs. The FDA has also authorized 560 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.