Key facts
- FDA advisors unanimously voted 9-0 to recommend Moderna's mRNA flu vaccine, mFlusiva.
- Phase 3 trials showed the vaccine was about 27% more effective than standard flu shots.
- A Trump appointee had previously attempted to block the vaccine's review, a decision later reversed.
- Moderna's CEO stated the vaccine could offer a new option for flu prevention.
- The FDA is expected to make a final decision by August 5.
Independent advisors to the Food and Drug Administration have unanimously voted in favor of approving Moderna's seasonal mRNA flu vaccine, branded as mFlusiva. The vaccine, known as mRNA-1010, demonstrated approximately 27% greater efficacy against seasonal flu compared to standard flu shots in Phase 3 trials involving over 40,000 adults aged 50 and older. A smaller trial focusing on individuals aged 65 and older showed that the mRNA vaccine elicits a stronger immune response than high-dose flu vaccines recommended for that demographic, with a generally good safety profile.
The unanimous vote by the VRBPAC committee marks a significant turnaround from earlier this year when a Trump administration appointee at the FDA, Vinay Prasad, initially rejected Moderna's filing without review. Prasad had questioned the trial's adequacy, specifically its comparison to high-dose vaccines for older adults, despite prior FDA agreement on Moderna's comparative approach. This decision, made against the advice of FDA scientists, sparked widespread criticism and was reversed the following week. Prasad was subsequently removed from the FDA at the end of April.
Moderna's CEO, Stéphane Bancel, expressed satisfaction with the committee's decision, highlighting the vaccine's potential to offer a new prevention option and showcase the versatility of the mRNA platform. The FDA has set a decision deadline for August 5. A subsequent recommendation from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) would be necessary for widespread insurance coverage, though a recent federal injunction has temporarily blocked many of the advisors appointed by Robert F. Kennedy Jr. to that committee.