The Food and Drug Administration’s independent advisers on Friday voted 9-0 to approve Moderna’s seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed.
In an all-day meeting, members of the VRBPAC advisory committee, known as the FDA’s Vaccines and Related Biologics Advisory Committee, reviewed information and presentations about the vaccine, called mRNA-1010, also known as mFlusiva. The presentations included feedback from FDA scientists who supported the vaccine.
Data from a Phase 3 trial involving more than 40,000 adults age 50 and older found that the mRNA vaccine was about 27 percent more effective than the standard flu vaccine against seasonal flu. A smaller Phase 3 trial, which included data on about 3,000 people age 65 and older, showed that the vaccine produced stronger immune responses than the high-dose flu vaccine recommended for this age group. The safety profile of the vaccine was also generally good.
“I think the research presented today was very well done,” VRBPAC voting member Flor Munoz-Rivas, a pediatric infectious disease specialist at Baylor College of Medicine, said after the vote. “They have very clear results that are very strong in terms of demonstrating this additional efficacy.”
He also expressed enthusiasm for a flexible mRNA platform for a flu vaccine based on the same platform Moderna used to develop mRNA COVID-19 vaccines. In addition to better efficacy, it allows for “rapid vaccine development in regular seasonal flu activity” and “better prepares us for future emerging strains or pandemic strains,” he said.
