Novavax Earns $125 Million as Sanofi Starts Joint Flu and COVID Trial
Key Facts
Novavax earned a $125 million milestone payment as Sanofi started a Phase 3 trial of a combined flu and COVID-19 vaccine, after the company defined trial initiation as vaccination of the fifth patient. Novavax said in its second-quarter results announcement that starting the trial in the United States or European Union would trigger the payment. The European trial registry describes the study as an authorized, confirmatory Phase 3 trial sponsored by Sanofi Vaccines US Inc. But the registry reported on 29 October 2026 that recruitment had not yet begun, meaning the payment is tied to meeting the contractual start condition defined by Novavax, not to completing enrollment or producing results. The payment does not mean the vaccine has been approved or proven effective; the trial is still testing immune response and safety.
The study targets adults aged 60 years and older and is testing a combination of recombinant SARS-CoV-2 spike protein and a high-dose inactivated flu vaccine, with the Matrix-M adjuvant. The EU registry plans to enroll 10,745 participants across 62 sites in 6 countries: Belgium, Germany, Spain, France, Poland and Portugal. The trial is designed as a randomized, multi-arm study with an active comparator group to assess safety and immunogenicity. Its primary objectives are to demonstrate that the immune response to the combination vaccine is non-inferior to the comparator arm for each of the three flu strains and the specified SARS-CoV-2 variants. Secondary objectives include describing safety and measuring seroconversion 28 days after vaccination.
ClinicalTrials.gov data cited in the EU registry give a different estimate of the study's size, indicating expected global enrollment of 6,000 participants. Those data set 9 November 2026 as the expected start date and 28 December 2027 as the expected primary completion date. These dates remain registered estimates, while the EU registry describes recruitment as not yet started. By design, the trial represents a broad comparative test in older adults, measuring the immune response to the flu and COVID-19 components. When released, its results will form part of the assessment of the combination vaccine's performance and safety; the milestone payment does not guarantee an outcome.
The current payment is part of a broader agreement announced by Novavax and Sanofi in May 2024, which grants Sanofi a license to use Novavax's COVID-19 adjuvant with its flu vaccines. Under the agreement, Sanofi has sole responsibility for developing and marketing any such combination vaccine, while Novavax receives tiered royalties in the high teens on sales of COVID-19 and combination vaccines. Novavax said total development and commercial launch milestone payments tied to Sanofi's combination products could reach $350 million. In addition to the current payment, a further $75 million is expected when the transfer of Nuvaxovid manufacturing technology to Sanofi is completed, which Novavax said is expected in mid-2027. These amounts are tied to separate contractual milestones, while royalties are linked to product sales.
Novavax recorded $225 million in milestone payments from Sanofi during 2025, including $50 million in the fourth quarter, alongside the transfer of marketing authorizations in the European Union and the United States. Novavax also said Sanofi informed it in December 2025 of positive data from Phase 1 and Phase 2 programs for combination flu and COVID-19 vaccines. The company said the data support the potential to demonstrate non-inferiority in Phase 3 compared with administering the two vaccines together. In its second-quarter 2026 announcement, Novavax said Sanofi would lead commercial activities for Nuvaxovid in selected markets during the 2026-2027 COVID vaccination season, including the United States. According to the same announcement, Novavax is entitled to royalties ranging from the high teens to the low twenties on Sanofi's global net sales.
The partnership's progress comes as Novavax's revenue has varied across reported periods. The company reported revenue of $57 million in the second quarter of 2026, down 76% from $239 million in the corresponding period of 2025. The company attributed higher product sales to increased demand for its Matrix-M adjuvant and partner sales. It also raised its 2026 adjusted revenue range to $235–275 million, from a previous estimate of $230–270 million. Cash, marketable securities and restricted cash totaled $724 million on 30 June 2026, compared with $751 million at the end of 2025. On 28 October 2026, Novavax shares closed at $10.32 and Sanofi shares at $42.24, according to EL7 data.