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:

  • Today, the FDA began releasing documents for the next meeting of the Advisory Committee on Vaccines and Related Biologics (VRBPAC), which will take place on Tuesday, October 26. The committee will meet in open session to discuss a request to amend Pfizer-BioNTech’s (EUA) emergency use authorization for the administration of their COVID-19 mRNA vaccine to children aged 5 to 11 years old.
  • On October 19, the FDA approved an abridged new drug application for succinylcholine chloride injection USP 200 mg / 10 ml, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to ensure relaxation of skeletal muscles during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help meet the critical needs of the American public.
  • Testing updates:
    • To date, 419 tests and specimen collection devices have been approved by the FDA under Emergency Use Authorizations (EUA). These include 292 molecular tests and specimen collection devices, 89 antibody tests and other immune response tests, and 38 antigen tests. There are 66 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, nine at-home over-the-counter (OTC) antigen prescription tests, and two at-home over-the-counter molecular tests.
    • The FDA has authorized 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also cleared 657 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.