U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine

Core Points - Novavax, Inc. has received FDA approval for its Nuvaxovid™ vaccine for active immunization against COVID-19 in adults aged 65 and older and individuals aged 12 to 64 with underlying conditions [1][5] - The approval has triggered a $175 million milestone payment from Sanofi, which is leading commercialization efforts for the vaccine [2][8] - Nuvaxovid is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S. and has been under Emergency Use Authorization since July 2022 [4][8] Company Developments - The approval is based on Phase 3 clinical trial data demonstrating the safety and efficacy of Nuvaxovid [3] - A new postmarketing commitment has been requested by the FDA for a Phase 4 trial in individuals aged 50 to 64 without high-risk conditions [3] - Novavax is preparing for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in partnership with Sanofi, pending FDA recommendations [4] Market Position - Market research indicates that older individuals and those with underlying conditions are likely to seek seasonal COVID-19 vaccinations, highlighting the importance of Nuvaxovid's approval [2] - Novavax is eligible for ongoing tiered royalties from future COVID-19 vaccine sales under its agreement with Sanofi [2]