FDA moves quickly toward formal Moderna EUA decision

By The Science Advisory Board staff writers

December 18, 2020 -- The U.S. Food and Drug Administration (FDA) has informed Moderna that it will work rapidly toward the issuance of an emergency use authorization (EUA) for the company's messenger RNA (mRNA) COVID-19 vaccine candidate, mRNA-1273.

The statement was given by Dr. Stephen Hahn, FDA commissioner, and Dr. Peter Marks, PhD, director of the FDA's Center for Biologics Evaluation and Research, following the December 17 meeting of the agency's Vaccines and Related Biological 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 of its intentions so that the execution of plans for timely vaccine distribution can begin.

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