FDA reverses course on rejection of Moderna's mRNA flu vaccine
6 days ago
- #Moderna
- #FDA
- #vaccine
- FDA reverses decision to reject Moderna's mRNA flu vaccine for approval.
- Initial rejection was made by political appointee Vinay Prasad, overruling agency scientists.
- Moderna held a Type A meeting with FDA, leading to agreement for review.
- Moderna's CEO expressed appreciation for FDA's engagement and hopes for approval by August 2026.
- Rejection was based on comparison vaccine used in Phase 3 trial, not Moderna's mRNA-1010.
- Moderna used standard-dose flu vaccines in trial, which Prasad deemed not 'adequate and well-controlled'.
- Moderna agreed to additional analysis comparing high-dose vaccine for older participants.