FDA advisory panel backs Moderna's seasonal mRNA flu vaccine unanimously

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously on Friday to recommend approval of Moderna’s seasonal mRNA flu vaccine, identified as mRNA-1010 and marketed as mFlusiva. Committee members reviewed data from a Phase 3 trial involving more than 40,000 adults aged 50 and older, which showed the vaccine was about 27 percent more effective than a standard flu shot. A smaller trial of nearly 3,000 participants aged 65 and older indicated stronger immune responses compared with a high-dose flu vaccine, and the overall safety profile was described as generally good.

"I think that the studies that were presented today were very well conducted," said VRBPAC voting member Flor Munoz-Rivas, a pediatric infectious disease specialist at Baylor College of Medicine. "They have very clear results that are very robust in terms of demonstrating additional efficacy."

"I think that this particular platform adds exciting ways that we can actually move our vaccines to the future," added fellow voting member Hayley Gans, a pediatric infectious disease expert at Stanford University. "The signals that we’re seeing now are not putting people at risk and the benefits are actually large not only for this season, but for what it can do for our vaccine platform."

The advisory panel’s endorsement follows a February decision by former FDA official Vinay Prasad, who declined to review the filing, arguing that the trial did not directly compare efficacy to a high-dose vaccine in seniors. After criticism from FDA scientists and career staff, the agency reversed that decision and agreed to proceed with the review. Prasad left the FDA in April.

Moderna welcomed the vote, with CEO Stéphane Bancel stating the company appreciates the panel’s “thoughtful review” and believes the vaccine could provide a new option for seasonal flu prevention. The FDA has set an August 5 deadline to make a final approval decision. If approved, the vaccine would next require a recommendation from the CDC’s Advisory Committee on Immunization Practices, which is currently stalled by a court injunction affecting its composition.