- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions to be taken in an ongoing effort to respond to the COVID-19 pandemic:
- Follow our updated on June 11 in the middle of BioSolutions and approval of certain sets of the Janssen COVID-19 drug, the agency is now authorized to use, under the emergency use permit (EUA) for the Janssen COVID-19 vaccine, an additional set of vaccine drug ingredients manufactured in the Outer condition. Currently a total of three components of Janssen’s medication made into Emergent are allowed. The FDA continues a thorough examination of facility records and the results of quality testing performed by the manufacturer. Consistent with this review and consideration of the current COVID-19 public health report, the FDA concluded that these batches should be used. While the FDA is not yet ready to include the Janssen EUA’s Emergent BioSolutions plant as an authorized manufacturing facility, the agency continues to work on issues there with the management of Janssen and Emergent BioSolutions.
- The FDA recently posted updated translations for the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers in multiple languages. Translations can be seen HERE.
- The agency updated this response to COVID-19 Response Summary of a Contents, which provides a quick look at the facts, figures and highlights of the FDA’s response effort.
- Test updates:
- To date, 384 test and sample collection devices have been approved by the FDA under emergency use permits (EUA). This includes 275 molecular tests and sample collection devices, 81 antibody and other resistance response tests and 28 antigen tests. There are 52 molecular tolerances and one antibody tolerance that can be used on samples collected at home. There is a home molecular prescription instruction, three home drug antigen tests, five over-the-counter (OTC) home antigen tests and two OTC home molecular tests.
- The FDA approved 11 antigen tests and three molecular tests for serial screening programs. The FDA also approved 534 revisions to the EUA permits.
The FDA, an internal agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for the control of tobacco products.