For immediate release:

The United States Food and Drug Administration today announced the following actions taken as part of its ongoing response efforts to the COVID-19 pandemic:

  • On August 22, the FDA updated the Emergency Use Authorization (EUA) of Pfizer-BioNTech to support the shelf life extension of 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 which may have expired before the modification of the EUA, provided that the product has been stored at the same temperatures.
  • Testing updates:
    • To date, 403 tests and specimen collection devices have been approved by the FDA under Emergency Use Authorizations (EUA). These include 283 molecular tests and specimen collection devices, 87 antibody tests and other immune response tests, and 33 antigen tests. There are 58 molecular clearances and one antibody clearance that can be used with home samples. There is one at-home molecular prescription test, three at-home antigen prescription tests, six at-home over-the-counter (OTC) antigen prescription tests, and two at-home over-the-counter molecular tests.
    • The FDA has authorized 13 antigen tests and eight molecular tests for serial screening programs. The FDA has also cleared 612 reviews of EUA authorizations.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.