Moderna's mRNA-1010 flu shot clears FDA and Health Canada review acceptance
Phase 3 data show a 26.6% relative efficacy edge over a licensed flu vaccine, and regulators in the US, Canada, EU and Australia have taken the filing under review ahead of Moderna's first potential flu approval.
Executive Summary
- Moderna's seasonal flu vaccine beat a licensed comparator on the trial's primary relative-efficacy measure, giving the company positive Phase 3 data to support its pending applications.
- Regulators in the United States, Canada, the European Union and Australia have all accepted the filing for review, moving the program from data readout into active regulatory review with a stated decision date.
- The trial carried multiple primary endpoints, and only the efficacy measure has a reported result; the safety profile that will also weigh on the decision has not been disclosed.
- An approval would give Moderna its first standalone flu vaccine and add a second commercial respiratory product alongside its approved COVID vaccine, expanding the seasonal-vaccine franchise the company has built its 2026 growth plan around.
The data
In the Phase 3 trial (NCT06602024), mRNA-1010 showed a relative vaccine efficacy of 26.6% (95% CI 16.7%-35.4%) against a licensed standard-dose seasonal influenza vaccine, including Fluarix, Fluarix Tetra, Influsplit Tetra and Alpharix Tetra, in adults 50 and older. Moderna disclosed the result in a New England Journal of Medicine publication of the pivotal Phase 3 (P304) safety and efficacy data. The trial registered four primary endpoints spanning adverse-event rates and time to first confirmed influenza-like illness; the efficacy endpoint is reported as met, while a second primary endpoint and all secondary endpoints, including hemagglutination-inhibition titers and seroconversion, were not reported. NCT06602024+1A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of AgeNCT06602024Moderna Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare ConferenceJan 12, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The trial
The randomized, active-comparator trial enrolled 40,817 adults age 50 and older across the United States and completed in August 2025. Enrollment finished below an earlier target of 56,000, a change the trial's own registry recorded at the same September 2025 update that marked the study Completed. The primary completion date also moved once, from December 2025 to June 2026, before the trial completed ahead of that revised date in August 2025. NCT06602024A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of AgeNCT06602024
Regulatory path
Moderna said it completed submissions for mRNA-1010 in the United States, Canada, Australia and Europe and expects potential approvals to begin in 2026, with a related flu/COVID combination filing, mRNA-1083, under review at the European Medicines Agency and pending further FDA guidance on refiling. By May and June 2026, the company disclosed that the FDA, Health Canada, the EMA and Australia's TGA had all accepted the mRNA-1010 application for review, with a stated FDA decision date of August 5, 2026. ModernaModerna Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare ConferenceJan 12, 2026
Why the endpoint bar matters
Moderna already has an approved COVID vaccine, mNEXSPIKE, and an approved RSV vaccine, mRESVIA, giving it a commercial track record in the same modality and regulatory pathway class. mRNA-1010 does not compete against an unvalidated mechanism: mRNA vaccines have already cleared FDA review in adjacent respiratory indications, so the bar for this decision is less about proving the mRNA platform and more about whether this specific efficacy margin and its undisclosed safety data satisfy the standard the agency applies to a licensed-comparator design. ModernaModerna Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare ConferenceJan 12, 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.