Speed, Evidence, Safety Characteristics of Vaccine Approvals by FDA

JAMA Internal Medicine

EMBARGOED FOR RELEASE: 1 P.M. (ET), TUESDAY, NOVEMBER 10, 2020

Media advisory: The full study is linked to this news release.

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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.

 

(doi:10.1001/jamainternmed.2020.7472)

Editor’s Note: The article includes conflict of interest disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

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