Novavax, Inc. (NVAX) announced Monday that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid for active immunization to prevent coronavirus disease 2019 (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.
The achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi SA (SNY).
The approval triggers a $175 million milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in May 2024.
Sanofi is leading on commercialization efforts starting this year and Novavax is eligible to receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales for all future vaccination seasons.
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.
In addition, the FDA has requested a new postmarketing commitment (PMC) to conduct a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19.
Novavax expects to be ready for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the U.S. this fall in partnership with Sanofi, pending strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting on May 22, 2025.
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