Independent advisers to the Food and Drug Administration on Friday voted 9-0 in favor of approving Moderna’s mRNA seasonal 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 FDA advisory committee, known as VRBPAC for the Vaccines and Related Biological Products Advisory Committee, pored over data and presentations about the vaccine, called mRNA-1010 and called mFlusiva. The presentations included a review of FDA scientists, who supported the vaccine.
Data from a Phase 3 trial that included more than 40,000 adults ages 50 and older found that the mRNA vaccine was about 27 percent more effective against seasonal flu than a standard flu vaccine. A smaller Phase 3 trial, which included data from nearly 3,000 people aged 65 and older, showed that the shot produces stronger immune responses than a high-dose flu vaccine, which is recommended for this age group. The safety profile of the vaccine was also generally good.
“I think the studies that were presented today were very well done,” Flor Muñoz-Rivas, a VRBPAC voting member and pediatric infectious diseases expert at Baylor College of Medicine, said after the vote. “They have very clear results that are very strong in terms of demonstrating that additional efficacy.”
He also expressed excitement about the agile flu vaccine mRNA platform, which is based on the same platform Moderna used to develop its COVID-19 mRNA vaccines. In addition to greater efficacy, it allows “rapid development of vaccines in the regular seasonal flu activity” and makes us “better prepared for emerging or pandemic strains in the future,” he said.
