The U.S. Food and Drug Administration (FDA) has approved Novavax, Inc.’s (Nasdaq: NVAX) Biologics license Application (BLA) for Nuvaxovid™ for coronavirus disease 2019 (COVID-19) vaccination. This active vaccine is approved for adults aged ≥65 years as well as those 12 to 64 years old, who have at least one underlying medical condition such as diabetes, cancer, obesity, asthma, or a history of smoking. These conditions raise their risk of severe COVID-19 outcomes.
The FDA approval has triggered a $175 million milestone payment under the partnership and licensing agreement between Sanofi and Novavax, which was signed in May 2024. As a result of this approval, Sanofi has made this payment to Novavax. The agreement outlines several commercial benefits for Novavax. Starting this year, Sanofi will lead the sales and marketing of the vaccine. Novavax is eligible to receive continuous royalties based on future sales of its standalone COVID-19 vaccine during upcoming vaccination seasons.
Nuvaxovid (NVX-CoV2705) is an updated, protein-based COVID-19 vaccine targeting the JN.1 variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is derived from Novavax’s (NVX-CoV2373) original vaccine by recombinant nanoparticle technology. The vaccine delivers a non-infectious spike protein that helps the immune system recognize the virus. Novavax’s Matrix-M® adjuvant boosts the immune response. It is a ready-to-use liquid stored at 2°C to 8°C, compatible with existing supply chains.
The FDA approved Nuvaxovid™ based on the results from a pivotal Phase 3 clinical trial demonstrating its safety and effectiveness in preventing COVID-19. The FDA also requested a new follow-up study called a post-marketing commitment (PMC) to carry out a Phase 4 prospective, randomized, double-blinded, placebo-controlled study. This study aims to evaluate the vaccine’s efficacy and safety in people aged 50 to 64 who don’t have high-risk health conditions of severe COVID-19. Novavax is working with Sanofi to plan and fund this new trial. This new commitment adds to previous follow-up studies commonly needed for COVID-19 vaccines.
Nuvaxovid™ should not be given to individuals with severe allergic reactions to its components or a previous Novavax dose. Medical treatment should be readily available in case of anaphylaxis. There is an increased risk of myocarditis and pericarditis following Nuvaxovid™ vaccination. Syncope (fainting) may also occur after the vaccine shot, so precautions should be taken to prevent injury. Common side effects include pain at the injection site, nausea, vomiting, fatigue, headache, malaise, and muscle pain.
“This FDA approval ensures access to Novavax’s protein-based, non-messenger ribonucleic acid (mRNA) COVID-19 vaccine for Americans aged ≥ 65 years and those 12-64 years with high-risk conditions,” said John C. Jacobs, President and Chief Executive Officer, Novavax. U.S. CDC statistics and market research emphasized that these groups are most likely to seek seasonal vaccination. This milestone highlights Novavax’s commitment to protecting the vulnerable population with an alternative vaccine option.
Novavax with Sanofi aims to launch the 2025-2026 COVID-19 vaccine in the U.S. this fall, pending FDA strain recommendations expected May 22, 2025. Nuvaxovid™ has been available under Emergency Use Authorization in the U.S. since July 2022. It holds full approval in Japan, Singapore, Taiwan, the European Union, Canada, and the United Kingdom.
Reference: Novavax. U.S. FDA Approves BLA for Novavax’s COVID-19 Vaccine. Published May 19, 2025. Accessed May 20, 2025. U.S. FDA Approves BLA for Novavax’s COVID-19 Vaccine – May 19, 2025
