Moderna's mRNA-1010 flu vaccine heads toward 2026 filings beyond the US
Two positive Phase 3 readouts, including 26.6% relative efficacy over a licensed flu shot, underpin Moderna's plan to file mRNA-1010 in more countries this year as its US review runs toward an August 5 PDUFA date.
Executive Summary
- Moderna is broadening where it seeks approval for its seasonal flu vaccine candidate, extending filings already under review in major markets to additional countries in 2026.
- The filings rest on a completed pivotal trial that met its prespecified superiority bar against a licensed flu vaccine in older adults, now published in a leading medical journal.
- This is the second Phase 3 trial for the vaccine candidate to report a positive efficacy result, adding to a consistent pattern across the program.
- The US regulatory decision lands within weeks, ahead of and independent from the broader multi-country filing plan, giving the program a nearer-term test of whether regulators accept the same dataset.
The plan
Moderna disclosed on May 6, 2026 that it intends to submit regulatory filings for mRNA-1010 in additional countries in 2026, on top of applications already accepted for review in the United States, Europe, Canada and Australia. The U.S. Food and Drug Administration has set a Prescription Drug User Fee Act goal date of August 5, 2026 for the domestic application. The expansion covers a vaccine candidate Moderna has run through six trials in seasonal influenza, all completed, none terminated. ModernaModerna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data for Its Investigational Seasonal Influenza Vaccine, mRNA-1010May 6, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The evidence behind the filings
The filings build on a completed Phase 3 trial, registered as NCT06602024, that enrolled 40,817 adults aged 50 and older and compared mRNA-1010 against a licensed standard-dose seasonal influenza vaccine. The trial's primary endpoints covered adverse events, adverse reactions, and time to first RT-PCR-confirmed influenza-like illness. Moderna reported that mRNA-1010 achieved the most stringent prespecified superiority criterion, with a relative vaccine efficacy of 26.6% (95% CI 16.7%-35.4%) against the licensed comparator in the overall study population. Efficacy held across individual strains, including 29.6% against A/H1N1, 22.2% against A/H3N2, and 29.1% against B/Victoria lineages, and reached 27.4% in participants 65 and older. Moderna Chief Executive Officer Stéphane Bancel said the published results reflect "the strength of the clinical evidence supporting our ongoing regulatory submissions". NCT06602024+1A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of AgeNCT06602024Moderna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data for Its Investigational Seasonal Influenza Vaccine, mRNA-1010May 6, 2026
Trial history and enrollment
The registry record for NCT06602024 shows enrollment finalized at 40,817, unchanged from the actual count logged at completion, and the trial reached Completed status on September 10, 2025. The primary completion date on record is August 21, 2025, after an earlier registry entry had pushed the target completion window from December 2025 to June 2026 before the trial closed ahead of that revised date. The vaccine's broader Phase 3 program has produced two prior positive readouts: an earlier trial (NCT05827978) met all immunogenicity primary endpoints with higher antibody titers than comparator vaccines, and another (NCT05566639) met the same superiority criterion later published in the New England Journal of Medicine. NCT06602024A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of AgeNCT06602024
Context: rising flu burden
Moderna's disclosure cites CDC data showing seasonal flu-related hospitalizations and outpatient visits reached a 15-year high in the 2024-2025 season, with more than 545,000 Americans hospitalized for flu-related illness. That backdrop frames the stated rationale for the multi-country filing push: an mRNA-based vaccine that Moderna says can more precisely match circulating strains than conventional egg- or cell-based flu vaccines. The competitive field in seasonal influenza vaccine development includes GlaxoSmithKline's mRNA-based candidates in Phase 1 and Phase 2 testing, with no other Phase 3 mRNA influenza vaccine yet reported to have completed a head-to-head efficacy comparison against a licensed vaccine. ModernaModerna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data for Its Investigational Seasonal Influenza Vaccine, mRNA-1010May 6, 2026
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.