- 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 Aug. 22, the FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months. The extension is also applicable to batches that might have expired prior to the EUA amendment, provided the product was stored at the same temperatures.
- Testing updates:
- As of today, 403 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 283 molecular tests and sample collection devices, 87 antibody and other immune response tests and 33 antigen tests. There are 58 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 612 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.
- Jim McKinney