Novavax's Nuvaxovid Gets XFG-Variant Approval in US, EU, and Japan Ahead of 2026-2027 Season

Novavax's partners have received regulatory approvals for an XFG variant-adapted formulation of Nuvaxovid to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in the US, European Union, and Japan.¹ In the US, Nuvaxovid is approved for individuals 65 and older, as well as those 12 through 64 with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes.² Novavax says these approvals position the company to continue earning royalties on partner net sales this season.¹

"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. With these approvals, Novavax is eligible for continued royalties on partner sales without carrying commercial infrastructure of our own, a testament to the value creation of our business model."¹

How does Nuvaxovid differ from mRNA COVID-19 vaccines?

Nuvaxovid is a protein-based, non-mRNA vaccine built on Novavax's recombinant nanoparticle and Matrix-M adjuvant technology, designed to stimulate an immune response using a purified spike protein antigen rather than genetic instructions for the body to produce that antigen.² A comprehensive review of Matrix-M-adjuvanted vaccines — covering 66 clinical trials and post-marketing studies in more than 10 million people — found the adjuvant supports potent, durable immunity through long-lasting memory B-cell and broad-based T-cell responses across multiple vaccine platforms.³ According to Novavax, results from Sanofi's Phase 4 COMPARE study, a head-to-head evaluation against a next-generation mRNA COVID-19 vaccine, showed a favorable tolerability profile for Nuvaxovid.² One practical distinction between platforms is distribution: Nuvaxovid can be stored at standard refrigerator temperatures rather than the ultra-cold conditions mRNA vaccines require. Cold-chain tracking remains a broader industry focus across vaccine platforms generally. "Before the pandemic, companies were using passive data loggers and manual processes primarily to achieve FDA compliance. Now, continuous monitoring of what is happening at the container level is crucial, because losses can't be afforded," said Mahesh Veerina, CEO of Cloudleaf, in earlier BioPharm International coverage of vaccine cold-chain tracking technology, unrelated to Nuvaxovid specifically.⁴ This approval comes alongside Pfizer and BioNTech's own XFG-adapted Comirnaty, which also received US approval for the 2026-2027 season.²

What's the commercial structure behind this approval?

Sanofi, Novavax's largest partner, leads Nuvaxovid commercialization across most major markets and is expanding US marketing activity while preparing launches in Germany, Canada, and other international markets from 2026 onward, under a 2024 collaboration and license agreement that provides Novavax ongoing royalties on net sales.¹ Takeda holds exclusive rights to develop, manufacture, and commercialize the vaccine in Japan; Nuvaxovid was the second-most used COVID-19 vaccine there during the 2025-2026 season, with delivery volumes and vaccination site numbers increasing significantly year over year.¹ Novavax is also eligible for annual milestones and royalties under a separate 2025 agreement with Takeda.¹ This partnered, royalty-based structure allows Novavax to earn revenue from Nuvaxovid sales without operating its own commercial sales infrastructure in these markets.¹

Why does variant-adapted approval matter each season?

COVID-19 remains a public health concern, particularly for older adults and other high-risk populations, and vaccine formulations are updated periodically to better match circulating variants.¹ Regulatory approval of an updated formulation each season is a prerequisite for commercial availability ahead of fall vaccination campaigns, making this approval a routine but necessary step in keeping Nuvaxovid available as an alternative to mRNA-based options.¹

What's next?

Commercial rollout of the updated formulation is expected to proceed through Sanofi's and Takeda's respective distribution networks as the 2026-2027 vaccination season begins, with Sanofi's launches in Germany, Canada, and other markets continuing through the year.¹

References

1. Novavax's partnership strategy continues to deliver with XFG-adapted Nuvaxovid approvals in the U.S., EU and Japan for 2026-2027 vaccination season. News release. Novavax, Inc.; August 28, 2026. Accessed August 31, 2026.
2. Novavax's XFG-adapted Nuvaxovid approved in U.S., EU, Japan for 2026-2027 season. RTTNews. Published August 28, 2026. Accessed August 31, 2026.
3. Hoyer J, et al. Safety of Matrix-M–adjuvanted COVID-19, seasonal influenza, combination influenza-COVID-19, and malaria vaccines: a review of the evidence. Hum Vaccin Immunother. 2026;22(1):2638828.
4. Markarian J. Accelerating technology adoption to track the cold chain. BioPharm International. 2021;34(1):38-40.