The New England Journal of Medicine has published the complete Phase 3 trial data for Moderna's investigational mRNA influenza vaccine mRNA-1010, providing the scientific community its first comprehensive look at the randomised controlled trial that demonstrated the shot outperformed a standard-dose quadrivalent flu vaccine across key efficacy endpoints. The publication follows Moderna's announcement earlier this week that its mRNA flu candidate had beaten the conventional comparator in late-stage testing, and represents the peer-reviewed confirmation that regulators and advisory bodies have been awaiting before formal review proceedings begin.
The trial, conducted across sites in the United States, Europe, and Australia during the 2024–2025 and 2025–2026 influenza seasons, enrolled more than 25,000 adults aged 18 and older. According to the published data, mRNA-1010 demonstrated statistically significant improvements in vaccine efficacy against both A and B strain influenza, including in seasons where antigenic drift created a mismatch between circulating viruses and the selected vaccine strains — historically the Achilles heel of egg-based manufacturing pipelines.
The CDC's Advisory Committee on Immunization Practices (ACIP) is expected to convene an emergency working group session in response to the publication, with members indicating they will assess whether the new data warrants expedited consideration ahead of the standard June plenary meeting. FDA officials have previously signalled that a Biologics License Application from Moderna for mRNA-1010 is under active rolling review, and the NEJM publication is considered a pivotal submission component. Analysts at SVB Securities estimate a potential FDA action date as early as the third quarter of 2026, which would position the vaccine for the 2026–2027 Northern Hemisphere flu season.
The results place significant competitive pressure on established flu vaccine manufacturers including Sanofi, whose Fluzone High-Dose franchise dominates the elderly segment, and Seqirus, the influenza vaccines division of CSL. Both companies have their own next-generation flu programmes in earlier development stages. Moderna shares rose modestly in pre-market trading on Friday following confirmation of the NEJM acceptance, and investors are watching closely for any further regulatory signals over the weekend.
Public health advocates have welcomed the data, noting that influenza kills between 300,000 and 650,000 people globally each year and that the flexibility of mRNA platforms to be reformulated rapidly in response to emerging strains could fundamentally change annual vaccine update timelines. Moderna's chief medical officer has indicated the company intends to pursue a combination mRNA influenza and COVID-19 booster product using the same platform technology, with that programme currently in Phase 2 development.