The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• On Sep. 24, Janet Woodcock, M.D., Acting FDA Commissioner and Peter Marks, M.D., Ph.D, director of the FDA’s Center for Biologics Evaluation and Research, discussed the FDA’s authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for certain populations with stakeholders. To listen and view the call, visit FDA’s YouTube channel.
• On Sep. 29, the FDA authorized an emergency use authorization (EUA) for one additional batch of the Janssen COVID-19 vaccine manufactured at the Emergent facility. To date, a total of nine batches of Janssen COVID-19 vaccine that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues on this matter with Janssen and Emergent BioSolutions management.
• Testing updates: 
  • As of today, 412 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 289 molecular tests and sample collection devices, 88 antibody and other immune response tests and 35 antigen tests. There are 65 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, seven antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
  • The FDA has authorized 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 641 revisions to EUA authorizations.

Related Information

###

---