AstraZeneca weighs seeking full U.S. approval for COVID-19 shot, skipping emergency use application

Wall Street Journal

7 May 2021 - British drugmaker faces challenges gathering data; may wait to apply for full approval by the FDA, which takes longer.

AstraZeneca could skip asking the FDA for emergency use authorisation for its COVID-19 vaccine, according to people familiar with the matter—and instead pursue the more time-intensive application for a full-fledged license to sell the shot.

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Michael Wonder

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Michael Wonder

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US , Regulation , Vaccine , Dossier , COVID-19