Novavax, Inc. (Nasdaq: NVAX) has officially transferred the U.S. marketing authorization for its protein-based COVID-19 vaccine, Nuvaxovid™, to French pharmaceutical giant Sanofi. This move gives Sanofi full control over commercial and regulatory operations in the U.S., completing a key step in their collaboration and license agreement (CLA).

The deal triggered the second of two $25 million milestone payments to Novavax, following the earlier European Union (EU) transfer in October 2025. Combined with prior achievements, Novavax has now secured a total of $225 million in milestone revenue through the partnership.

A Strategic Win for Both Players
“With the successful achievement of our BLA approval and completion of both U.S. and EU marketing authorization transfers for Nuvaxovid™ to Sanofi, we have delivered on our partnership agreement,” said John C. Jacobs, President and CEO of Novavax. “We look forward to Sanofi’s success in globally marketing our protein-based, non-mRNA COVID-19 vaccine in the years to come.”

For Sanofi, this transfer strengthens its vaccine portfolio, particularly as demand shifts toward protein-based alternatives to mRNA formulations. Nuvaxovid’s protein-based platform—boosted by Novavax’s proprietary Matrix-M® adjuvant—has been viewed as a potential option for those seeking traditional vaccine technology.

What’s Next for Novavax and Sanofi
Novavax isn’t done yet. Under the CLA, the company is eligible for additional milestone payments and royalties. These will be tied to future vaccine combinations and new products Sanofi develops using Nuvaxovid or the Matrix-M® adjuvant system.

This collaboration underscores a broader industry trend toward cross-licensing and diversification of COVID-19 vaccine technologies. As mRNA fatigue and storage limitations surface, traditional protein-based vaccines are seeing renewed global interest. Sanofi’s distribution scale could bring Nuvaxovid to broader populations, particularly in regions where cold-chain logistics remain a challenge.

Vaccine Authorization and Safety Profile
Nuvaxovid is authorized in the U.S. for active immunization against COVID-19 in individuals aged 65 and older, or those aged 12 to 64 with high-risk conditions.

Safety Notes and Precautions:

• Contraindications: Avoid use in individuals with known severe allergic reactions to vaccine components or prior Novavax doses.

• Warnings: Cases of myocarditis, pericarditis, and syncope have been reported post-vaccination. Medical management should be readily available to handle allergic responses.

• Limitations: Immunocompromised individuals may have a reduced immune response, and protection is not guaranteed for all recipients.

For detailed safety information, the CDC provides comprehensive clinical considerations related to myocarditis and pericarditis post-vaccination.

Market Implications
The completion of this transfer positions Novavax to focus more on research and development, while Sanofi leverages its global commercial muscle. With both U.S. and EU authorizations in its hands, Sanofi now holds the keys to expanding Nuvaxovid’s footprint across major markets.

As the vaccine landscape matures, this alliance could serve as a model for strategic partnerships between innovators and established pharma distributors. It’s a calculated move—one that blends innovation with reach and may redefine how next-generation vaccines reach global consumers.

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