- 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:
- Following our update on June 11 on the Emergent BioSolutions facility and the authorization of certain batches of the Janssen COVID-19 vaccine drug substance, today the agency authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date a total of three batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of 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 there with Janssen and Emergent BioSolutions management.
- The FDA recently posted the updated translations for the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers in multiple languages. The translations can be found here.
- The agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA’s response efforts.
- Testing updates:
- As of today, 384 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 275 molecular tests and sample collection devices, 81 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 534 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.