Moderna shares climbed 3.37% in pre-market trading Thursday after the FDA approved mFLUSIVA for adults 50 and older nationwide. The stock hit $58.15, rebounding from Wednesday's close of $56.26. The clearance marks the company's fourth approved product in the U.S. market and expands its footprint in seasonal respiratory vaccines.
The FDA backed mFLUSIVA following unanimous support from its Vaccines and Related Biological Products Advisory Committee. Moderna's mRNA platform targets seasonal flu strains, offering another option for older adults who face higher risks from influenza. A commercial launch is set for the 2026-2027 respiratory virus season.
Phase 3 Trial Backs Safety Profile
The main trial tracked 40,805 adults aged 50 and older across 11 countries, comparing mFLUSIVA against standard-dose flu vaccines using lab-confirmed illness outcomes. The FDA granted standard approval for ages 50-64 based on efficacy and safety data from this larger international study. A separate U.S. trial of 2,992 participants supported accelerated approval for adults 65 and older, measuring immune responses without raising new safety concerns.
The vaccine joins Spikevax, mRESVIA, and mNEXSPIKE in Moderna's U.S. lineup, covering COVID-19, RSV, and now flu prevention. That portfolio positions the company for recurring seasonal vaccination programs. Regulators in Europe, Canada, and Australia are currently reviewing Moderna's mRNA-1010 candidate.
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