FDA reverses course and will review Moderna's mRNA flu shot, company says
6 days ago
- #Moderna
- #FDA
- #mRNA vaccine
- The FDA reversed its decision and will now review Moderna's mRNA flu vaccine after initially refusing the application.
- The initial refusal was due to the application lacking an 'adequate and well-controlled' trial, not safety or efficacy concerns.
- Moderna proposed a revised regulatory approach, seeking full approval for adults 50-64 and accelerated approval for those 65+.
- If approved, the vaccine could be available for people 50+ in the 2026-2027 flu season.
- Moderna's CEO expressed appreciation for the FDA's engagement and hopes to offer the vaccine to seniors this year.