mRNA-1010 - (P304)

August 5, 2026: Moderna (NASDAQ: MRNA) said the FDA approved mFLUSIVA (mRNA-1010), an mRNA seasonal influenza vaccine, for adults aged 50 and older. The approval covers prevention of influenza caused by influenza A subtypes and type B represented in the vaccine.

For adults 50-64, approval was based on a randomized, observer-blind, active-controlled Phase 3 trial (NCT06602024) in 40,805 adults across 11 countries that evaluated safety/reactogenicity and relative vaccine efficacy versus a standard-dose comparator against RT-PCR-confirmed protocol-defined influenza-like illness from any influenza A or B strains. For adults 65 and older, FDA granted accelerated approval based on immunogenicity results from a randomized, observer-blind, active-controlled trial (NCT05827978) in 2,992 U.S. adults versus a high-dose inactivated influenza vaccine comparator, with descriptive relative vaccine efficacy support from NCT06602024. Continued approval in the 65+ group will depend on confirmatory postmarketing evidence of clinical benefit.

Moderna said the Phase 3 program showed an acceptable safety profile with no new safety concerns. The company expects U.S. supply for the 2026-2027 respiratory virus season in coming weeks/select retailers. mRNA-1010 has also been accepted for regulatory review in the EU, Canada, and Australia, with additional country filings planned in 2026.