Moderna's experimental mRNA influenza vaccine for older adults advanced toward final U.S. regulatory approval on Wednesday, following a positive recommendation from a Food and Drug Administration advisory panel. The committee backed the vaccine for use in people aged 65 and older, positioning it as a potential new tool against seasonal flu.
The advisory committee's endorsement was based on Phase 3 trial data showing improved immune responses compared with standard flu shots in older patients. Moderna, based in Cambridge, Massachusetts, is applying its mRNA platform beyond Covid-19 to target respiratory illnesses.
Influenza remains a significant driver of hospitalizations and deaths among older adults each winter. The U.S. Centers for Disease Control and Prevention estimates tens of thousands of deaths in severe seasons. Existing high-dose and adjuvanted vaccines already target this population, and an mRNA alternative would intensify competition with Sanofi and CSL Seqirus.
Analysts said the advisory backing strengthens Moderna's case for approval and a possible launch before the 2026-27 flu season. Moderna has also been developing a combined influenza and Covid-19 vaccine, which depends on regulatory acceptance of its standalone flu candidate.
A Moderna spokesperson said the company would continue working with the FDA to support its review and was prepared to supply doses if the vaccine secured approval before the autumn vaccination campaign.