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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