Moderna Shares Jump 5.9% as FDA Accepts Flu Vaccine Application
Moderna shares rose 5.9% after the FDA agreed to review its amended mRNA-1010 seasonal flu vaccine application, reversing a prior refusal to file. The FDA set an August 5, 2026 target decision date for full approval in adults 50–64 and accelerated approval for those 65+, aiming for the 2026–27 season.
1. FDA Review of Amended Flu Vaccine Application
Moderna received FDA agreement to review its amended mRNA-1010 seasonal flu vaccine application after a prior refusal to file, triggering a 5.9% share price increase.
2. Age-Based Approval Strategy
The company sought full approval for adults aged 50 to 64 and accelerated approval for those 65 and older by revising its application with an age-stratified approach.
3. Decision Timeline and Next Steps
The FDA set an August 5, 2026 target decision date, positioning Moderna to potentially offer the vaccine for the 2026–27 flu season pending approval.