FDA in final stages before issuing Pfizer, BioNTech EUA

By The Science Advisory Board staff writers

December 11, 2020 -- The U.S. Food and Drug Administration (FDA) has informed Pfizer and BioNTech that it will work rapidly toward the finalization and issuance of an emergency use authorization (EUA) for the company's COVID-19 vaccine candidate.

The statement was given by Dr. Stephen Hahn, the FDA commissioner and Dr. Peter Marks, PhD, the director of the Center for Biologics Evaluation and Research, following the December 10 meeting of the Vaccines and Related Biologicals Products Advisory Committee (VRBPAC), which produced a positive outcome.

In addition to notifying the sponsors, the FDA also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed so that execution of plans for a timely vaccine distribution can begin.


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