U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine

Rhea-AI Summary

The FDA has approved Novavax's (NVAX) Biologics License Application for Nuvaxovid™, its COVID-19 vaccine. The approval is for adults 65+ and individuals 12-64 with high-risk conditions. This triggers a $175 million milestone payment from Sanofi under their May 2024 collaboration agreement, which includes future tiered royalties. Nuvaxovid is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S. The FDA has requested a new Phase 4 trial for individuals 50-64 without high-risk conditions. Novavax plans to deliver the 2025-2026 COVID-19 vaccine formula this fall through Sanofi, pending strain recommendations. The vaccine has been available under Emergency Use Authorization since July 2022 and has full market approvals in multiple countries.

Positive

• FDA approval triggers immediate $175 million milestone payment from Sanofi
• Additional future revenue stream through tiered royalties from Sanofi partnership
• Only non-mRNA COVID-19 vaccine option in the U.S. market, providing competitive differentiation
• Broad international approval across major markets including EU, UK, Japan, and Canada

Negative

• Limited approval scope to adults 65+ and high-risk individuals 12-64 years
• Required to conduct additional Phase 4 trial for ages 50-64 without high-risk conditions
• Known safety risks including myocarditis and pericarditis
• Dependent on Sanofi for U.S. commercialization efforts

Insights

Biotechnology Investment Analyst

Novavax secures FDA BLA approval for its COVID-19 vaccine, triggering $175M payment from Sanofi with future royalty potential.

The FDA's approval of Novavax's Biologics License Application (BLA) for Nuvaxovid™ represents a significant regulatory milestone with immediate financial implications. The approval triggers a $175 million milestone payment from Sanofi under their May 2024 collaboration agreement. This cash infusion strengthens Novavax's financial position considerably.

Importantly, this isn't just a one-time payment – the approval establishes a recurring revenue stream through tiered royalties from future COVID-19 vaccine sales, creating a more sustainable business model for Novavax. The company had previously operated under Emergency Use Authorization since July 2022, but this full approval provides regulatory certainty and commercial legitimacy.

The approved indication targets precisely the demographic segments most likely to seek COVID vaccination: adults 65 and older and those 12-64 with high-risk conditions. This strategic positioning aligns perfectly with CDC vaccination statistics and creates a defined market niche for Novavax's protein-based alternative to mRNA vaccines.

While the FDA has requested a new Phase 4 trial for individuals aged 50-64 without high-risk conditions as a postmarketing commitment, this is fairly standard for vaccine approvals and unlikely to materially impact near-term revenue potential. The approval timing also allows Novavax and Sanofi to prepare for commercial delivery of the 2025-2026 COVID-19 vaccine formula this fall, assuming strain recommendations are finalized at the upcoming May 22 advisory committee meeting.

The partnership structure with Sanofi is particularly valuable – Novavax benefits from Sanofi's commercial infrastructure while maintaining significant economic interest through milestone payments and royalties, effectively reducing commercial risk while preserving upside potential.

Pharmaceutical Industry Specialist

This FDA approval establishes Nuvaxovid as the only non-mRNA, protein-based COVID-19 vaccine available in the U.S. market – a critical differentiator in a field dominated by mRNA technology platforms from Pfizer and Moderna. This unique positioning allows Novavax to target vaccine-hesitant individuals specifically concerned about mRNA technology.

The approval scope covering adults 65+ and high-risk individuals aged 12-64 addresses approximately 40-45% of the potential vaccination market, but crucially targets those most likely to seek seasonal COVID-19 vaccination. The commercial partnership with Sanofi is structured intelligently – leveraging Sanofi's extensive commercial infrastructure while preserving Novavax's economic upside through royalties.

While the required Phase 4 trial adds some additional regulatory burden, such postmarketing requirements have become standard for COVID-19 vaccines. The FDA's request for this specific trial suggests potential interest in expanding the indication to additional populations in the future if safety and efficacy are further confirmed.

Notably, this U.S. approval complements existing approvals in major markets including the EU, UK, Japan, and Canada, creating a global commercial footprint for Nuvaxovid. The timing of this approval is particularly advantageous, allowing sufficient preparation for the 2025-2026 vaccination season beginning this fall.

From a competitive standpoint, while mRNA platforms have dominated the COVID vaccine landscape, Novavax's protein-based approach uses well-established vaccine technology with decades of safety data. This approval validates their traditional approach against newer technologies and opens the door for potential application of their Matrix-M adjuvant technology to other vaccine targets in their pipeline.

• Nuvaxovid™ is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S.
• Biologics License Application approval triggers $175 million Sanofi milestone payment, with additional COVID-19 vaccine milestones and ongoing tiered royalties to be recognized when earned

GAITHERSBURG, Md., May 19, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid™ for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).¹ Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi.

"Today's approval solidifies a pathway for Americans aged 65 and older and those aged 12 through 64 with an underlying condition that puts them at high risk for severe outcomes from COVID-19 to have access to a protein-based, non-mRNA COVID-19 vaccine," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."

The approval triggers a $175 million milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in May 2024. The agreement has layers of value for Novavax. Sanofi is leading on commercialization efforts starting this year and Novavax is eligible to receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales for all future vaccination seasons.

The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19.^2,3 In addition, the FDA has requested a new postmarketing commitment (PMC) to conduct a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. Novavax is working closely with Sanofi to assess funding and execution of this new trial. This PMC supplements previously agreed upon postmarketing requirements and commitments which have been commonly required for COVID-19 vaccine manufacturers.

Novavax expects to be ready for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the U.S. this fall in partnership with Sanofi, pending strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting on May 22, 2025. 

Nuvaxovid has been available for use in the U.S. under Emergency Use Authorization since July 2022 and has full market approvals in the European Union, United Kingdom, Japan, Canada, Australia, Taiwan and Singapore.

VACCINE AUTHORIZATION (U.S.)
Nuvaxovid is a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

IMPORTANT SAFETY INFORMATION
Contraindications

• Do not administer Nuvaxovid to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of Nuvaxovid or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of Novavax COVID-19 Vaccine, Adjuvanted.

Warnings and Precautions

• Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of Nuvaxovid.
• Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Nuvaxovid. There have been post-marketing reports of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted. The Centers for Disease Control and Prevention (CDC) has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
• Syncope (fainting): Syncope (fainting) may occur in association with administration of injectable vaccines, including Nuvaxovid. Procedures should be in place to avoid injury from fainting.
• Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to Nuvaxovid.
• Limitations of Vaccine Effectiveness: Nuvaxovid may not protect all vaccine recipients.

Adverse Reactions
Solicited adverse reactions included: Injection site tenderness, injection site pain, headache, muscle pain, fatigue, malaise, joint pain, fever, nausea/vomiting and injection site redness.

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.

About Nuvaxovid^™
Nuvaxovid (NVX-CoV2705) is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of 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 as a ready-to-use liquid formulation 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 or medicine 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 and allows use of a lower dose of antigen that is still effective.⁴ Matrix-M is sustainably harvested and manufactured and has the potential to enhance existing and new vaccines. When combined with the Company's recombinant, protein-based nanoparticles, this technology platform is 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 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 efficacy, safety and intended utilization of Novavax's COVID-19 vaccine, the possible achievement of additional milestones under the Sanofi agreement, its intention to file a supplemental BLA (sBLA) for the 2025-2026 vaccination season, the immunogenic response of its vaccine technology against variant strains and the scope, 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 or delays related to the requested PMC or in obtaining further regulatory authorization for its COVID-19 vaccine, including approval of the sBLA; 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 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 a JN.1 protein-based COVID-19 vaccine or 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, as updated by the information identified in the "Risk Factors" section in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each 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
Luis Sanay, CFA
240-268-2022
ir@novavax.com

Media
Giovanna Chandler
240-720-7804
media@novavax.com

References

1. Centers for Disease Control and Prevention. Underlying Conditions and the Higher Risk for Severe COVID-19: https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html. Accessed online May 18, 2025.
2. Dunkle LM. et al; 2019nCoV-301 Study Group. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. New England Journal of Medicine. 2022;386(6):531-543. doi:10.1056/NEJMoa2116185.
3. Áñez G. et al. Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(4):e239135. doi:10.1001/jamanetworkopen.2023.9135.
4. 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 is the significance of NVAX's FDA approval for Nuvaxovid?

The FDA approval establishes Nuvaxovid as the only protein-based, non-mRNA COVID-19 vaccine in the U.S., triggers a $175M payment from Sanofi, and enables vaccine access for adults 65+ and high-risk individuals 12-64 years old.

How much will Novavax receive from Sanofi for the FDA approval?

Novavax will receive a $175 million milestone payment from Sanofi, plus future tiered royalties from stand-alone COVID-19 vaccine sales.

What age groups are approved for Novavax's COVID-19 vaccine?

The vaccine is approved for adults 65 years and older, and individuals 12-64 years who have at least one high-risk condition for severe COVID-19 outcomes.

What are the main side effects of Novavax's Nuvaxovid vaccine?

Main side effects include injection site tenderness/pain, headache, muscle pain, fatigue, malaise, joint pain, fever, nausea/vomiting, and potential risks of myocarditis and pericarditis.

When will Novavax's 2025-2026 COVID vaccine be available?

Novavax expects to deliver the 2025-2026 formula in fall 2025, pending strain recommendations at the FDA advisory committee meeting on May 22, 2025.