Core Viewpoint - Novavax's Nuvaxovid™ has been approved by the U.S. FDA for the 2025-2026 vaccination season, making it the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for high-risk adults aged 12 to 64 and seniors aged 65 and older [1][4]. Group 1: Vaccine Approval and Target Population - The FDA approval allows Nuvaxovid to be administered to adults 65 years and older, or individuals aged 12 to 64 with at least one underlying condition that increases their risk for severe COVID-19 outcomes [1][4]. - Novavax plans to collaborate with Sanofi to ensure access to the vaccine for eligible individuals this fall [2]. Group 2: Clinical Data and Efficacy - Clinical and preclinical data indicate that Nuvaxovid is safe and effective against COVID-19, particularly the JN.1 strain, which is responsible for the majority of global infections as of July 2025 [3]. - The vaccine induces immunity across various circulating strains within the JN.1 lineage, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7, and XEC [3]. Group 3: Commercialization and Royalties - Sanofi is leading the commercialization efforts for Nuvaxovid, while Novavax is set to receive ongoing tiered royalties from the vaccine sales [3]. Group 4: Vaccine Composition and Technology - Nuvaxovid is a protein-based vaccine that targets the JN.1 variant, utilizing Novavax's recombinant nanoparticle technology to create copies of the SARS-CoV-2 spike protein [8][9]. - The Matrix-M® adjuvant enhances the immune response and allows for a lower dose of the antigen while maintaining effectiveness [10]. Group 5: Company Overview - Novavax, Inc. focuses on addressing significant health challenges through its expertise in vaccines and technology platforms, including protein-based nanoparticles and the Matrix-M adjuvant [11]. - The company's growth strategy includes optimizing existing partnerships, expanding access to its technology, and pursuing research and development innovations [11].

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]