Moderna to seek FDA emergency authorization after COVID-19 vaccine shows 94% efficacy in final analysis
Moderna announced Monday it will ask the Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company, after Pfizer, to seek EUA for a COVID-19 vaccine in the United States.
Pfizer's public FDA hearing -- a crucial step in the authorization process -- is scheduled for Dec. 10, and the FDA could make its official authorization decision shortly thereafter. In an early morning press release, Moderna announced that its FDA hearing will be held a week later, on Dec. 17. Moderna also announced its coronavirus vaccine is more than 94% effective, according to the final analysis of its massive Phase 3 trial.
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