FDA advisory committee members voted unanimously Friday to recommend approval of Moderna's mRNA flu vaccine, ending months of controversy that began when a Trump appointee initially blocked the vaccine from review. The mRNA-1010 vaccine, branded as mFlusiva, represents Moderna's expansion beyond COVID-19 shots into seasonal flu prevention.

Clinical data showed promising results across two Phase 3 trials. The larger study of over 40,000 adults age 50 and older demonstrated the vaccine was approximately 27 percent more effective than standard flu shots. A separate trial involving nearly 3,000 seniors found stronger immune responses compared to high-dose vaccines typically recommended for that age group. Advisors praised the robust clinical evidence and the platform's potential for rapid vaccine development.

The path to this recommendation was rocky. In February, Vinay Prasad rejected Moderna's filing, claiming inadequate trial design despite prior FDA agreement on the approach. FDA scientists and career officials objected, and the agency reversed the decision within a week. Prasad's departure in April followed broader controversies, including blocking UniQure's Huntington's disease gene therapy.

Now the FDA faces a August 5 deadline for final approval. Even if approved, insurance coverage hurdles remain since the CDC's advisory committee is currently inactive following a federal judge's injunction against Health Secretary Robert F. Kennedy Jr.'s appointees. Moderna aims to launch the vaccine later this year, pending both FDA and CDC green lights.