Novavax's Nuvaxovid COVID-19 Vaccine Receives Full FDA Approval for Adults 65+ and High-Risk Individuals Aged 12-64
Novavax Inc. has received full FDA approval for its Nuvaxovid COVID-19 vaccine, which is now licensed for adults 65+ and high-risk individuals aged 12-64. This approval is based on Phase 3 clinical trial data demonstrating safety and effectiveness. Nuvaxovid is the only non-mRNA protein-based COVID-19 vaccine in the U.S. Sanofi will handle its commercialization and distribution, enhancing access for those seeking vaccination.
Novavax Inc. has announced that the Nuvaxovid™ COVID-19 vaccine has received full regulatory approval from the U.S. Food and Drug Administration (FDA). This approval, based on pivotal Phase 3 clinical trial data demonstrating safety and effectiveness, marks a significant milestone for the company. Nuvaxovid is now fully licensed for use in adults 65 years and older, as well as individuals aged 12 through 64 who are at higher risk for severe COVID-19 outcomes. The vaccine is the only non-mRNA protein-based COVID-19 vaccine available in the United States, offering an important alternative to other vaccines. Additionally, Sanofi has taken on the responsibility for the commercialization of Nuvaxovid and has begun distributing it across healthcare providers and retailers in the U.S. This development ensures broader access and choice for eligible individuals seeking vaccination against COVID-19. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Novavax Inc. published the original content used to generate this news brief on September 19, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
