Full Press Release Details
Novavax Completes U.S. Marketing Authorization
Transfer to Sanofi for Nuvaxovid , Triggering a $25 Million Milestone Payment
GAITHERSBURG, Md., November 4, 2025 -
Novavax, Inc. (Nasdaq: NVAX) has completed the transfer of the U.S. marketing authorization for its COVID-19 vaccine, Nuvaxovid
to Sanofi, enabling Sanofi to take full responsibility for commercial and regulatory activities in the U.S. and fulfilling part of its
collaboration and license agreement (CLA). The transfer triggered the second of two $25 million marketing authorization transfer
milestone payments to Novavax, following the European Union (EU) transfer completed in October 2025.
"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 additional milestone revenue to date," said John C. Jacobs, President and Chief
Executive Officer, Novavax. "We look forward to Sanofi's success in globally marketing our protein-based, non-mRNA COVID-19
vaccine in the years to come."
Novavax is eligible to receive additional future
milestones and royalties under the CLA related to Nuvaxovid, combination products developed by Sanofi using Nuvaxovid and new vaccines
created by Sanofi utilizing Novavax's Matrix-M adjuvant.
VACCINE AUTHORIZATION (U.S.)
Nuvaxovid is a vaccine indicated for active immunization
to prevent COVID-19 caused by SARS-CoV-2 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one
underlying condition that puts them at high risk for severe outcomes from COVID-19.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
The most commonly reported (>10%) solicited
adverse reactions were injection site tenderness, injection site pain, injection site redness, headache, muscle pain, fatigue, malaise,
joint pain, fever and nausea/vomiting.
To report suspected adverse reactions, contact
Novavax, Inc. at 1-844-668-2829 or the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.
Novavax, Inc. (Nasdaq: NVAX) tackles some of the
world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based
nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to
its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond,
and forging new partnerships and collaborations with other companies. Please visit novavax.com and LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax,
its operating plans and prospects, the possible achievement of additional milestones or receipt of milestone payments or royalties under
the CLA, future marketing initiatives and the potential development and commercialization of Sanofi combination products, and efforts
to pursue additional partnerships, are forward-looking statements. Novavax cautions that these forward-looking statements are subject
to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.
These risks and uncertainties include, without limitation, challenges related to Novavax's partnership with Sanofi and in pursuing additional
partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy and product characterization
requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities;
difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on
the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for future COVID-19
variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's
exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions
in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the
year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC).
We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged
to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks
and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake
no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those
referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.