Novavax's Partnership Strategy Continues to Deliver with XFG-adapted Nuvaxovid™ Approvals in the U.S., EU and Japan for 2026-2027 Vaccination Season

Rhea-AI Summary

Novavax (Nasdaq: NVAX) announced that its partners have received approvals for an XFG-variant–adapted Nuvaxovid™ COVID-19 vaccine for the 2026-2027 vaccination season in major markets including the U.S., European Union and Japan, positioning the company to continue earning royalties on net sales.

According to Novavax, Sanofi leads commercialization in most major markets, is expanding U.S. marketing and is launching in Germany, Canada and other markets from 2026 onward under a 2024 collaboration and license agreement that provides ongoing royalties. In Japan, Takeda commercializes Nuvaxovid, which was the second-most used COVID-19 vaccine in the 2025-2026 season, with significantly higher delivery volumes and site numbers year over year, triggering annual milestones and seasonal royalties for Novavax.

The company highlighted Phase 4 COMPARE study results from Sanofi showing Nuvaxovid’s favorable tolerability profile versus a next-generation mRNA vaccine, and described the protein-based, non-mRNA formulation, Matrix-M® adjuvant technology and standard 2°–8°C storage as key product attributes.

Positive

• XFG-adapted Nuvaxovid approvals in U.S., EU and Japan for 2026-2027 season
• Royalty stream from partner net sales under 2024 collaboration and license agreement
• Annual milestones and royalties from Takeda commercialization in Japan under 2025 CLA terms
• Nuvaxovid second-most used COVID-19 vaccine in Japan in 2025-2026 season
• COMPARE Phase 4 study showed Nuvaxovid favorable tolerability versus a next-generation mRNA vaccine

Negative

• None.

Market Context

Current data classified NVAX's short positioning as high. Against that backdrop, the approvals add a...

Analysis

Current data classified NVAX's short positioning as high. Against that backdrop, the approvals add a royalty-linked commercial datapoint, while dependence on partner collaborations remains a risk to monitor.

Key Figures

Vaccination season: 2026-2027 season Study phase: Phase 4 Japan vaccine ranking: Second-most used +3 more

6 metrics

Vaccination season 2026-2027 season Nuvaxovid XFG-adapted formulation approvals

Study phase Phase 4 Sanofi COMPARE study

Japan vaccine ranking Second-most used 2025-2026 vaccination season

Storage temperature 2° to 8°C Nuvaxovid pre-filled syringes

Collaboration agreement 2024 Novavax royalty agreement

CLA terms May 2025 Annual milestones and royalties

Previous Partnership Reports

2 past events · Latest: Oct 07 (Positive)

Same Type Pattern 2 events

Date	Event	Sentiment	24h Move	Catalyst
Oct 07	Partnership milestone	Positive	+1.5%	EU authorization transfer triggered a $25 million milestone payment and continued royalty eligibility.
Dec 13	Partnership agreement	Positive	+1.0%	Sanofi partnership delivered a $50 million milestone and established future royalty and milestone eligibility.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Both tag-specific partnership events aligned with positive 24-hour reactions, with no observed divergence.

Key Terms

sars-cov-2, antigen, adjuvant, cold chain

4 terms

sars-cov-2 medical

"target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season"

SARS-CoV-2 is the virus that causes the illness known as COVID-19; think of it as a biological engine that can start chains of sickness in people. It matters to investors because its spread and the measures taken to control it—such as changes to workforce availability, consumer demand, supply chains, travel, and healthcare spending—can quickly alter company revenues, costs and regulatory priorities, much like a sudden storm that affects many parts of an economy at once.

antigen medical

"the spike protein serves as the antigen that primes the immune system"

A molecule or part of a molecule—often from a virus, bacterium, or abnormal cell—that the immune system recognizes as foreign and reacts to, like a unique fingerprint or smoke detector setting off an alarm. Investors watch antigens because they are the targets for vaccines, diagnostic tests, and certain therapies; changes in how an antigen behaves or is detected can affect product effectiveness, regulatory approval, market demand, and company valuation.

adjuvant medical

"Novavax's Matrix-M adjuvant enhances and broadens the immune response"

An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.

cold chain technical

"enabling the use of existing vaccine supply and cold chain channels"

A cold chain is the continuous temperature-controlled system used to store and transport products that must stay cold, such as vaccines, biologic medicines, and some foods — think of a refrigerator on wheels and in warehouses that keeps items at specific temperatures from factory to customer. Investors watch cold chain strength because failures raise product loss, regulatory trouble, and extra costs, while reliable cold chains protect sales, margins, and a company’s reputation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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
ir@novavax.com

Media
Yvonne Sprow
844-264-8571
media@novavax.com

References

1. 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.
2. 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.

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SOURCE Novavax, Inc.

FAQ

What did Novavax (NVAX) announce about XFG-adapted Nuvaxovid approvals for the 2026-2027 season?

Novavax announced that partners secured approvals for its XFG-adapted Nuvaxovid COVID-19 vaccine in the U.S., EU and Japan for the 2026-2027 season. According to Novavax, these approvals enable ongoing royalties on partner net sales across these major markets during the upcoming vaccination season.

How do Sanofi and Takeda partnerships impact Novavax (NVAX) royalties from Nuvaxovid sales?

Sanofi and Takeda commercialize Nuvaxovid on Novavax’s behalf and generate royalty income. According to Novavax, the 2024 collaboration with Sanofi and 2025 agreement with Takeda provide ongoing royalties and, in Japan, annual milestones tied to regulatory approvals and seasonal net sales performance.

What were the key Phase 4 COMPARE study findings for Nuvaxovid mentioned by Novavax (NVAX)?

The Phase 4 COMPARE study showed Nuvaxovid had a favorable tolerability profile versus a next-generation mRNA COVID-19 vaccine. According to Novavax, this large head-to-head evaluation supports Nuvaxovid as a protein-based, non-mRNA option that healthcare providers may consider when making informed vaccine choices.

How did Nuvaxovid perform in Japan before the 2026-2027 COVID-19 vaccination season?

In the 2025-2026 season, Nuvaxovid was the second-most used COVID-19 vaccine in Japan. According to Novavax, Takeda’s commercialization led to significantly increased delivery volumes and a higher number of sites receiving the vaccine year over year, supporting related milestones and royalties.

What are the main product features of Novavax’s XFG-adapted Nuvaxovid vaccine?

Nuvaxovid is a protein-based, non-mRNA COVID-19 vaccine targeting the XFG variant. According to Novavax, it uses recombinant spike protein nanoparticles with the Matrix-M adjuvant, is supplied in pre-filled syringes, and is stored at 2° to 8°C using existing vaccine cold chain infrastructure.

How does Novavax’s Matrix-M adjuvant support its vaccine pipeline and Nuvaxovid?

Matrix-M is Novavax’s proprietary adjuvant designed to enhance immune responses in vaccines. According to Novavax, it is clinically proven to induce potent, durable and broad immune responses with an acceptable safety and tolerability profile and underpins the company’s expanding recombinant protein-based vaccine pipeline.

What role does partnering play in Novavax’s (NVAX) overall growth strategy?

Partnering is one of three key pillars in Novavax’s corporate growth strategy. According to Novavax, the company aims to maximize impact through partnerships for marketed products like Nuvaxovid and R21/Matrix-M, Matrix technology and R&D assets, while maintaining targeted, capital-efficient innovation and a lean operating model.