GAITHERSBURG, Md. — Novavax said its partners have received regulatory approvals for an updated formulation of Nuvaxovid targeting the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in the United States, the European Union and Japan.
The approvals position the protein-based, non-mRNA COVID-19 vaccine for use in the upcoming vaccination season and allow Novavax to continue earning royalties on sales by its commercial partners.
Sanofi leads the commercialization of Nuvaxovid across most major markets and is expanding its U.S. marketing efforts while preparing for launches in Germany, Canada, and other international markets. Novavax receives royalties on vaccine sales under the companies’ 2024 collaboration and license agreement.
“We believe our partners Sanofi and Takeda are well-positioned for this commercial season,” said John C. Jacobs, president and chief executive officer of Novavax. “Sanofi has an expanded U.S. marketing campaign and launches in additional international markets, and under Takeda’s leadership, Nuvaxovid has become the second-leading COVID-19 vaccine in one of the world’s largest healthcare markets.”
Takeda commercializes Nuvaxovid in Japan, where it was the second most-used COVID-19 vaccine during the 2025-2026 season, according to Novavax. The company said delivery volumes and the number of vaccination sites receiving Nuvaxovid increased significantly year over year.
Novavax earns annual milestones tied to regulatory approvals as well as royalties on Takeda’s net sales in Japan.
The updated Nuvaxovid is formulated to target the XFG variant. The vaccine uses recombinant protein nanoparticle technology combined with Novavax’s Matrix-M adjuvant to stimulate an immune response.
Nuvaxovid is supplied in pre-filled syringes and can be stored at temperatures between 2°C and 8°C, enabling it to move through existing vaccine supply and cold-chain infrastructure.
Novavax said the vaccine offers healthcare providers and patients a protein-based alternative to mRNA COVID-19 vaccines, particularly as COVID-19 continues to pose risks to older adults and other high-risk populations.
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