FDA ‘rapidly’ working toward finalizing, issuing emergency use authorization for Pfizer’s vaccine

Coronavirus

WASHINGTON (WPRI) — The United States could be shipping out doses of what is likely to be the first vaccine to prevent COVID-19 at any moment.

Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration, issued a statement following Thursday night’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC.

The committee voted overwhelmingly in favor of endorsing Pfizer’s vaccine for emergency use authorization.

Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.

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.

Statement From:
Commissioner of Food and Drugs – Food and Drug Administration Stephen M. Hahn M.D.
Director – Center for Biologics Evaluation and Research (CBER) Peter Marks M.D., PhD.

Alex Azar, Secretary of U.S. Health and Human Services, also shared the news on Twitter.

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