Novavax合作伙伴Sanofi与Takeda的XFG适配Nuvaxovid疫苗获美国、欧盟及日本批准，用于2026-2027接种季

- COVID-19 remains a public health challenge, particularly among older adults and high-risk populations1
- Novavax's partners are ready to bring its protein-based, non-mRNA vaccine with a favorable tolerability profile to global markets, providing an important option for healthcare providers and patients
GAITHERSBURG, Md., Aug. 28, 2026 /PRNewswire/ -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major markets including the U.S., European Union (EU) and Japan. These approvals position Novavax to continue earning royalties on net sales in these markets this season.
"We believe our partners Sanofi and Takeda are well-positioned for this commercial season. 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," said John C. Jacobs, President and Chief Executive Officer, Novavax. "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."
COVID-19 continues to present a meaningful public health challenge, particularly among older adults and other high-risk populations. Novavax is committed to working with its partners to ensure a protein-based, non-mRNA vaccine option is available for the fall season. Results from Sanofi's Phase 4 COMPARE study – a large head-to-head evaluation of Nuvaxovid and a next-generation mRNA COVID-19 vaccine – demonstrated Nuvaxovid's favorable tolerability profile, an important consideration for healthcare providers and patients when making informed vaccine choices.
Sanofi, Novavax's largest partner, leads Nuvaxovid commercial activities across most major markets and looks to be positioned for a robust 2026-2027 season, expanding the vaccine's commercial reach through broader activities in the U.S. and launches in Germany, Canada and other international markets from 2026 onward. Novavax is eligible to receive ongoing royalties from sales of the vaccine per their 2024 collaboration and license agreement (CLA).
Takeda commercializes Nuvaxovid in Japan. In the 2025-2026 season, Nuvaxovid was the second-most used COVID-19 vaccine in Japan, with delivery volumes and the number of sites receiving the vaccine increasing significantly year over year. Under the CLA terms announced in May 2025, Novavax earns annual milestones tied to regulatory approvals and royalties on net sales each season.
About Nuvaxovid™
Nuvaxovid is formulated to target the XFG variant. It is a protein-based vaccine made by creating copies of the surface spike protein of the SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged in pre-filled syringes and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M® Adjuvant
Matrix-M is Novavax's proprietary adjuvant that can be added to a vaccine to stimulate a stronger immune response and is currently used in globally approved vaccines. It is clinically proven to induce potent, durable and broad immune responses with an acceptable safety and tolerability profile.2 The Company's recombinant, protein-based nanoparticles are combined with its Matrix-M adjuvant, constituting the basis of Novavax's expanding pipeline.
About Novavax
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 its Matrix-M adjuvant and protein-based nanoparticles. The Company's corporate growth strategy is designed to deliver value via three key strategic pillars: partnering its technology, targeted and capital-efficient R&D innovation and a lean and efficient operating model. This includes maximizing impact through partnerships for its marketed products (Nuvaxovid, R21/Matrix-M), Matrix technology and R&D assets. 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 and timing of achievement of milestone and receipt of royalties under the collaboration and licensing agreements with Sanofi and Takeda, and our partners' ability to launch products and operate effectively in U.S. and international markets, 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, antigenic drift or shift in the SARS-CoV-2 spike protein; challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; challenges or delays in obtaining commercial adoption and market acceptance of its COVID-19 vaccine or any COVID-19 variant strain containing formulation; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; 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, 2025, 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.
Contacts:
Investors
Naina Zaman
240-410-5353
[email protected]
Media
Yvonne Sprow
844-264-8571
[email protected]
References
- CDC. (2025). People with Certain Medical Conditions and COVID-19 Risk Factors, Updated June 11, 2025. Available from: https://www.cdc.gov/covid/risk-factors/index.html. Accessed August 24, 2026.
- Stertman L. et al.; The Matrix-M™ adjuvant: A critical component of vaccines for the 21st century. Hum Vaccin Immunother. 2023 Dec 31;19(1):2189885. doi: 10.1080/21645515.2023.2189885.
SOURCE Novavax, Inc.