Novavax Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application $(BLA.AU)$ for its COVID-19 vaccine, Nuvaxovid™, aimed at preventing COVID-19 in adults 65 years and older, as well as individuals aged 12 through 64 with at least one high-risk condition. The approval has resulted in a $175 million milestone payment from Sanofi, with whom Novavax has a collaboration and license agreement. The agreement also includes ongoing tiered royalties from future COVID-19 vaccine sales. Additionally, the FDA has requested a Phase 4 trial to further assess the vaccine's efficacy and safety in individuals aged 50 through 64 without high-risk conditions. Novavax is working with Sanofi to plan this trial, which supplements previously established postmarketing commitments. The company anticipates readiness for the commercial delivery of its 2025-2026 vaccine formula in the U.S. this fall, contingent on the FDA's strain recommendation decision expected on May 22, 2025.
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