FDA Approves Moderna's mFLUSIVA, the World's First mRNA Seasonal Influenza Vaccine

FDA Approves Moderna's mFLUSIVA, the World's First mRNA Seasonal Influenza Vaccine

In a landmark milestone for vaccinology and public health, the U.S. Food and Drug Administration (FDA) approved Moderna's mFLUSIVA (mRNA-1010) on August 5, 2026, for the prevention of seasonal influenza in adults aged 50 years and older. This approval marks the world's first approved messenger RNA (mRNA)-based seasonal influenza vaccine, successfully expanding the clinical and commercial footprint of the mRNA platform beyond COVID-19 and RSV.¹

The FDA's decision was supported by a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June 2026 and robust clinical data from a pivotal Phase 3 trial (NCT06602024) involving over 40,000 participants. The trial demonstrated that mFLUSIVA elicited superior immunogenicity and a favorable safety profile compared to traditional active-controlled flu vaccines in the 50-to-64 and 65-and-older age cohorts.

This milestone is particularly significant given the regulatory hurdles Moderna overcame earlier in the year. In February 2026, the FDA issued a rare Refusal-to-File (RTF) letter for mRNA-1010, citing concerns over the original trial design and statistical parameters. Moderna rapidly resolved these concerns by aligning on a revised data package, culminating in the accelerated review and subsequent approval of the vaccine ahead of the 2026-2027 respiratory virus season.

While the approval represents a major technical achievement, public health experts note that commercial adoption and zero-cost insurance coverage for seniors will ultimately depend on a formal recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP).