On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64 years with at least one underlying condition putting them at high risk for severe outcomes. Novavax previously entered into a collaboration and license agreement with Sanofi in May 2024 to co-commercialize a COVID-19 vaccine. Pursuant to the terms of the agreement, FDA approval of the vaccine triggered a $175 million milestone payment from Sanofi to Novavax. Novavax expects the 2025-2026 Nuvaxovid™ formula to be ready for commercial delivery in the U.S. this fall in partnership with Sanofi, pending strain recommendation from the FDA Vaccines and Related Biological Products Advisory Committee meeting held on May 22, 2025.
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