MFLUSIVA FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 10, 2026.

FDA Approved: Yes (First approved August 5, 2026)
Brand name: mFLUSIVA
Generic name: influenza vaccine, mRNA
Dosage form: Injection
Previous Name: mRNA-1010
Company: Moderna, Inc.
Treatment for: Influenza Prophylaxis

mFLUSIVA (influenza vaccine, mRNA) is an mRNA-based flu vaccine for for the prevention of influenza disease.

• mFLUSIVA is indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine. mFLUSIVA is approved for use in persons 50 years of age and older.
  - The indication for persons 65 years of age and older is approved under accelerated approval based on immune responses. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• mFLUSIVA works by encoding the full-length hemagglutinin (HA) glycoproteins of the three influenza virus strains represented in the vaccine. After the mRNA is delivered into cells, it serves as a template for synthesis of these HA proteins. The expressed, membrane-bound HA glycoproteins are then recognized by immune cells as a foreign antigen, triggering an immune response that contributes to protection against influenza.
• FDA approval of mFLUSIVA in adults 50 through 64 years of age was based on results from a randomized, observer-blind, active-controlled, Phase 3 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.
  FDA accelerated approval of mFLUSIVA in adults 65 years of age and older was 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 (HD) inactivated influenza vaccine comparator. The effectiveness of mFLUSIVA in adults 65 years of age and older was also supported by the descriptive analysis of rVE in the randomized, observer-blind, active-controlled, Phase 3 clinical trial (NCT06602024). Confirmation of clinical benefit in this population will be assessed in a postmarketing clinical trial.
• mFLUSIVA is administered as a single dose intramuscular injection.
• Warnings and precations associated with mFLUSIVA include anaphylactic reactions and Guillain-Barré syndrome.
• Common adverse reactions (≥10%):
  - in participants 50 through 64 years of age include injection site pain (68.7%), fatigue (48.1%), headache (41.9%), myalgia (40.6%), arthralgia (31.5%), chills (27.5%), and axillary (underarm) swelling or tenderness (20.3%).
  - in participants 65 years of age and older include injection site pain (62.9%), fatigue (42.1%), headache (33.7%), myalgia (30.2%), arthralgia (24.1%), chills (18.1%), and axillary (underarm) swelling or tenderness (14.2%).

Development timeline for mFLUSIVA

Further information

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