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06 Nov 2025
Admin
News Article

Novavax Transfers U.S. Marketing Authorization for Nuvaxovid to Sanofi

Gaithersburg, Maryland: Novavax, Inc. announced the completion of the U.S. marketing authorization transfer for its COVID-19 vaccine, Nuvaxovid, to Sanofi, granting the French pharmaceutical company full responsibility for commercial and regulatory activities in the United States.

This move fulfills a key element of the collaboration and license agreement (CLA) between the two companies and triggers the second of two $25 million milestone payments to Novavax, following the European Union (EU) transfer completed earlier in October 2025.

Milestone Achieved Under Collaboration Agreement

“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 and secured $225 million in milestone revenue to date,” said John C. Jacobs, President and Chief Executive Officer of Novavax.

Jacobs added that Novavax looks forward to Sanofi’s success in “globally marketing our protein-based, non-mRNA COVID-19 vaccine in the years to come.”

Under the agreement, Novavax remains eligible to receive additional milestone payments and royalties tied to:

Sales of Nuvaxovid
Combination products developed by Sanofi incorporating Nuvaxovid
Future vaccines created by Sanofi that utilize Novavax’s proprietary Matrix-M adjuvant technology

About Nuvaxovid

Nuvaxovid is a protein-based COVID-19 vaccine indicated for:

Active immunization against SARS-CoV-2
Individuals 65 years and older, or
Those aged 12–64 years with at least one underlying condition increasing risk of severe COVID-19 outcomes

Unlike mRNA-based vaccines, Nuvaxovid uses recombinant nanoparticle technology combined with the Matrix-M adjuvant, designed to enhance immune response while maintaining a favorable safety profile.

Novavax’s Strategic Focus

Novavax, Inc. is advancing its protein-based vaccine platform to address global infectious disease challenges. The company continues to leverage:

Established technology based on protein nanoparticles and Matrix-M adjuvant
Strategic partnerships to expand global access and market reach
Research and development initiatives targeting infectious and emerging diseases

Novavax’s current growth strategy includes optimizing existing alliances, expanding its vaccine portfolio, and pursuing new collaborations to broaden its impact across the biopharmaceutical landscape.

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