The U.S. FDA has granted full approval to Novavax’s Nuvaxovid COVID-19 vaccine for older adults and individuals with high-risk conditions, expanding access to a non-mRNA option.
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| Novavax’s FDA-approved COVID-19 vaccine, Nuvaxovid, offers a protein-based immunization alternative for high-risk and elderly populations in the United States. Image: CH |
Gaithersburg, Maryland, USA – May 19, 2025:
Novavax, has announced that the U.S. Food and Drug Administration (FDA) has officially approved the Biologics License Application (BLA) for Nuvaxovid, its COVID-19 vaccine designed for adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying health condition that increases their risk of severe illness from COVID-19. The approved conditions include, but are not limited to, asthma, cancer, diabetes, obesity, and smoking-related health issues.
This FDA approval marks a pivotal moment for Novavax and enhances vaccine access for vulnerable populations, providing a non-mRNA alternative amid ongoing global health efforts. The regulatory milestone has also triggered a $175 million milestone payment from Sanofi, as part of a collaboration agreement established in May 2024. Under this agreement, Sanofi will take the lead on commercial distribution, while Novavax will receive tiered royalties from standalone vaccine sales for future seasonal campaigns.
John C. Jacobs, President and Chief Executive Officer of Novavax, highlighted the importance of this development, stating that the approval ensures access to a protein-based COVID-19 vaccine for high-risk individuals and older adults, groups identified by CDC data as the most likely to seek annual vaccinations. He added that this achievement reflects Novavax’s continued dedication to safeguarding these populations.
The approval is grounded in Phase 3 clinical trial data that confirmed the safety and efficacy of Nuvaxovid in preventing COVID-19. The FDA has also requested a postmarketing Phase 4 trial focusing on individuals aged 50 to 64 without underlying conditions. Novavax is currently coordinating with Sanofi to secure funding and prepare for the execution of this new trial, which will complement previously agreed postmarketing requirements common to COVID-19 vaccine producers.
Novavax anticipates readiness for commercial distribution of the 2025–2026 vaccine formulation this fall, pending strain selection at the upcoming FDA Vaccines and Related Biological Products Advisory Committee meeting scheduled for May 22, 2025. Nuvaxovid has been distributed in the U.S. under Emergency Use Authorization since July 2022 and is already fully approved in several global markets, including the European Union, United Kingdom, Japan, Canada, Australia, Taiwan, and Singapore.
The vaccine is approved for the prevention of COVID-19 in specified populations and may present increased risks in certain cases. Individuals with a history of severe allergic reactions to vaccine components should avoid Nuvaxovid, and healthcare professionals are advised to be prepared for potential anaphylactic reactions. Clinical data also indicate increased risks of myocarditis and pericarditis, and there have been post-marketing reports confirming such outcomes. Fainting can occur following injection, and individuals who are immunocompromised may have reduced vaccine response. As with all vaccines, Nuvaxovid may not offer complete protection for all recipients.
The most commonly reported adverse reactions include tenderness and pain at the injection site, fatigue, headache, muscle and joint pain, nausea, malaise, and fever. Despite these effects, the approval of Nuvaxovid represents a critical step in diversifying the COVID-19 immunization portfolio in the United States and meeting the ongoing healthcare needs of at-risk communities.