FDA Approves mRNA Flu Vaccine
The FDA based its approval for adults aged 50 to 64 years on phase 3 trial results, while use in adults aged 65 years and older received accelerated approval.
By
Kathryn Wighton
August 6, 2026
Clinical Scorecard: FDA Approves mRNA Flu Vaccine
At a Glance
Category Detail
Condition Influenza Key Mechanisms mRNA-based vaccine targeting influenza A and B Target Population Adults aged 50 years and older Care Setting Vaccination clinics
Key Highlights
First mRNA-based influenza vaccine approved by FDA Approved for adults aged 50 years and older Based on phase 3 trial with 40,805 participants Accelerated approval for adults aged 65 years and older Safety findings reported as acceptable with common local and systemic adverse events Guideline-Based Recommendations
Diagnosis
Management
Vaccination with mFLUSIVA for eligible adults Monitoring & Follow-up
Monitor for adverse reactions post-vaccination Risks
History of severe allergic reaction to any ingredient in mFLUSIVA Patient & Prescribing Data
Adults aged 50 years and older
Continued approval may depend on confirmatory trial results
Clinical Best Practices
Ensure patients are screened for allergies to vaccine components Educate patients on potential adverse events Related Resources & Content
