Moderna completes application for full FDA authorization of COVID-19 vaccine
Moderna today the completion of its biologic license application to the Food and Drug Administration for its mRNA COVID-19 vaccine. The application comes with a request for priority review. Moderna since May has submitted data sections to the FDA on a rolling basis, the complete body of which reviewed its COVID-19 vaccine’s efficacy and safety in more than 30,000 U.S. phase 3 trial participants. Moderna says its final analysis indicates that its vaccine has a 93% efficacy, which persisted through six months after completion of a two-dose regimen.
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