mRNA-1010 - (P304)

May 6, 2026: Moderna, Inc. (NASDAQ: MRNA) announced publication in the New England Journal of Medicine of positive Phase 3 (P304) results for mRNA-1010, its seasonal influenza vaccine candidate, in adults aged ≥50 years, comparing relative vaccine efficacy (rVE) vs a licensed standard-dose flu vaccine. mRNA-1010 met the protocol’s most stringent prespecified superiority criterion with overall rVE of 26.6% (95% CI 16.7%–35.4%). Strain-specific rVE was reported as 29.6% for A/H1N1, 22.2% for A/H3N2, and 29.1% for B/Victoria lineages. In participants aged ≥65 years, rVE was 27.4%, with subgroup analyses indicating consistent rVE point estimates across age groups, risk factors, and prior vaccination status.

Regulatory filings for mRNA-1010 have been accepted for review in the U.S., Europe, Canada, and Australia. Moderna received an FDA PDUFA goal date of August 5, 2026, and expects potential approvals to begin in 2026. Additional country submissions are planned for 2026.