Breaking News, Trials & Filings

FDA Approves Novavax COVID-19 Vaccine for High-Risk Adults

The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Novavax Inc.’s Nuvaxovid for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Achievement of the U.S. license approval has triggered a $175 million milestone payment ...

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