FDA Approves First mRNA Influenza Vaccine

The U.S. Food and Drug Administration (FDA) has approved mFLUSIVA (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older.

Approval is based on results from a randomized, observer-blind, active-controlled, Phase III clinical trial (NCT06602024), which enrolled 40,805 adults aged 50 years and older across 11 countries. The primary objectives in this study were to evaluate the safety and reactogenicity of mFLUSIVA, and to evaluate relative vaccine efficacy (rVE) of mFLUSIVA versus a standard dose (SD) active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.

Use in adults 65 years of age and older was granted accelerated approval based on results from a randomized, observer-blind, active-controlled clinical trial (NCT05827978), which enrolled 2,992 adults 65 years of age and older in the United States. The primary objective in this study was to evaluate the immunogenicity of mFLUSIVA versus a high-dose inactivated influenza vaccine comparator. The effectiveness of mFLUSIVA in adults 65 years of age and older is also supported by the descriptive analysis of rVE in the randomized, observer-blind, active-controlled, Phase III clinical trial. Confirmation of clinical benefit in this population will be assessed in a postmarketing clinical trial.

The Phase III program demonstrated an acceptable safety profile for mFLUSIVA, with no new safety concerns identified, consistent with previously reported studies of mFLUSIVA.

Moderna expects to have mFLUSIVA available for eligible populations in the U.S. for the 2026-2027 respiratory virus season.