Novavax said Oct. 29 that a fifth participant had received a dose in Sanofi’s Phase 3 influenza-COVID-19 vaccine study in Europe, earning Novavax a $125 million milestone under its collaboration agreement.
The study pairs Novavax’s Nuvaxovid with Sanofi’s Efluelda/Fluzone High-Dose influenza vaccine. Researchers are assessing safety and immune responses in adults 60 and older. Novavax’s announcement did not specify when Sanofi would pay the milestone.
The contract ties the $125 million milestone to dosing the fifth patient in the first pivotal trial of a Sanofi influenza-COVID-19 combination product covered by its license with Novavax. For this milestone, Sanofi, an affiliate or sublicensee must conduct the study, or have it conducted on its behalf, in the United States or an EU country.
Registry pages updated before Oct. 29 showed earlier recruitment statuses. The EU record, updated Oct. 14, marked the trial authorized with recruitment pending; ClinicalTrials.gov, updated Oct. 22, said it was not yet recruiting and gave an anticipated Nov. 9, 2026, start date. Neither pre-announcement entry records the fifth-patient dose reported by Novavax.
The records also differ on planned enrollment: the EU listing gives 10,745 participants, including 5,945 in the EU/EEA, while ClinicalTrials.gov lists 6,000 worldwide. Neither listing explains the gap.
Novavax President and Chief Executive Officer John C. Jacobs said the partnership had generated more than $1 billion in revenue. The company says that total combines revenue recorded through June 30, 2026, from upfront payments, milestones, research and development reimbursements and royalties with the milestone earned in October. The collaboration began in May 2024 with a nonrefundable $500 million upfront payment to Novavax, according to its SEC filing.
The agreement provides for another $75 million when manufacturing technology transfer is complete, a step Novavax expects in mid-2027. A separate $225 million milestone is contractually tied to the first U.S. commercial sale of the first licensed combination product.
ClinicalTrials.gov lists Nov. 9, 2026, as the trial’s anticipated start date.
