Novavax earns a $125 million milestone as Sanofi starts a Phase 3 trial of its influenza-COVID-19 combination vaccine in adults aged 60 and older.
Written By: Khushi Patel, PharmD
Reviewed By: Pharmacally Editorial Team
Novavax has earned a $125 million milestone payment after Sanofi dosed the fifth participant in a Phase 3 trial evaluating a combination vaccine against influenza and COVID-19 in adults aged 60 years and older. The payment advances a partnership that has already generated more than $1 billion in revenue for Novavax, with additional manufacturing, commercialization and royalty opportunities ahead.
Phase 3 Trial Advances Combination Vaccine Development
The European Phase 3 trial is evaluating Sanofi’s high-dose influenza vaccine, Efluelda, marketed as Fluzone High-Dose in the United States, alongside Novavax’s protein-based COVID-19 vaccine, Nuvaxovid. The study will assess the combination’s safety and immunogenicity in adults aged 60 and older, a population at increased risk of severe respiratory infections.
The fifth-patient dosing milestone triggered the $125 million payment under the companies’ collaboration and licensing agreement. The trial marks a further step toward a potential combined vaccination option that could protect older adults against both respiratory viruses through a single vaccination regimen.
However, the initiation milestone does not establish the combination vaccine’s clinical efficacy, safety profile or regulatory prospects. Those questions will depend on the Phase 3 findings and subsequent regulatory assessments.
Scientific Rationale and Market Opportunity
Influenza and COVID-19 continue to contribute to respiratory illness, hospitalisations and deaths, particularly among older adults. Combining vaccines could simplify seasonal immunisation and potentially improve vaccination uptake by reducing the number of separate injections required.
The candidate combines Sanofi’s established high-dose influenza vaccine with Nuvaxovid, which uses recombinant spike protein to stimulate an immune response against SARS-CoV-2. Nuvaxovid also incorporates Novavax’s Matrix-M adjuvant, which enhances immune responses to the vaccine antigen.
The companies are targeting a market that Novavax estimates has a combined global value exceeding $10 billion for influenza and COVID-19 vaccines. Commercial performance, however, will depend on clinical results, regulatory approval, vaccine recommendations, pricing and competition from other combination products.
Additional Milestones and Royalties Remain Ahead
The $125 million payment is one component of a broader agreement that links Novavax’s financial returns to Sanofi’s development, manufacturing and commercial progress.
Novavax is eligible for a further $75 million milestone payment following successful completion of the manufacturing technology transfer, which the company anticipates around mid-2027. A separate $225 million milestone is tied to a potential US launch of an influenza-COVID-19 combination vaccine, following successful completion of Sanofi’s clinical and regulatory requirements in the country.
The agreement also provides for royalties on Sanofi’s sales of Nuvaxovid and qualifying combination products incorporating the vaccine. Additional milestones and royalties could arise from new Sanofi vaccines developed using Novavax’s Matrix-M adjuvant.
These terms create several potential revenue streams, but the future payments remain conditional on the specified development, manufacturing and commercial milestones.
Partnership Expands Novavax’s Commercial Reach
Novavax President and Chief Executive Officer John C. Jacobs said the partnership had generated more than $1 billion in revenue for the company to date. He also highlighted Sanofi’s intention to become an early participant in the combination vaccine market.
For Novavax, the collaboration offers a route to commercial reach through Sanofi’s vaccine business without requiring Novavax to independently manage every aspect of development and global commercialisation. For Sanofi, the agreement provides access to Novavax’s COVID-19 vaccine technology and adjuvant platform.
The next important developments will be the Phase 3 trial results and completion of the manufacturing technology transfer. If clinical and regulatory requirements are met, a US launch could trigger the additional $225 million payment and open a further royalty-generating market.
The current milestone confirms progress in the partnership, but the combination vaccine’s eventual commercial value will depend on clinical evidence, regulatory decisions and market adoption.
Reference
Novavax Earns $125 Million Milestone as Sanofi Launches Phase 3 Influenza-COVID-19 Combination Vaccine Trial in Europe, Novavax, 29 October 2026
About the Writer
Khushi Patel is a Pharm.D (Linkedin) professional with a strong foundation in clinical pharmacy, patient-centered care, regulatory affairs, and pharmacovigilance, with published work on Brugada syndrome.
Her interests include regulatory affairs, pharmacovigilance, guideline integration, multimodal therapy, pharmacogenomics, and antibiogram utilization, with a focus on evidence-based clinical decision-making and medication safety.
As a Pharmacally healthcare writer, she translates clinical and scientific evidence into clear, accurate, and clinically relevant healthcare content, while continuously developing her expertise in evolving pharmacy practice.