What The Study Did: Amid an urgent need to develop a safe and effective vaccine to prevent COVID-19, researchers evaluated all new vaccines approved by the U.S. Food and Drug Administration over the last decade, characterizing premarket development and regulatory review times, the clinical evidence on which approval was based, and the size and follow-up duration of the prelicensure safety database.
Authors: Joseph S. Ross, M.D., M.H.S., of the Yale University School of Medicine in New Haven, Connecticut, is the corresponding author.
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