Moderna's mRNA Flu Vaccine Faces FDA Scrutiny Amidst Approval Dispute

The FDA is reviewing Moderna's new mRNA-based flu vaccine application following a dispute over trial participants. Moderna claims the trial design was FDA-approved, while FDA's vaccine chief criticized it. Moderna seeks full approval for adults 50-64 and accelerated approval for those over 65.

Moderna's innovative mRNA flu vaccine is under review by the FDA after resolving a dispute over its application process.

The controversy arose due to FDA vaccine chief Dr. Vinay Prasad's refusal to review the trial data, which Moderna argues was previously agreed upon.

Now, Moderna aims for full approval for adults aged 50 to 64 and accelerated approval for seniors, with further studies post-market launch, reflecting ongoing scrutiny under Health Secretary Robert F. Kennedy Jr.