Independent advisers to the Food and Drug Administration voted 9-0 on Friday in support of approving Moderna’s seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even getting reviewed.
At the all-day meeting, members of the FDA’s advisory committee — known as VRBPAC for Vaccines and Related Biological Products Advisory Committee — considered data and presentations on the vaccine, called mRNA-1010 and branded as mFlusiva. The presentations included a review from FDA scientists, who supported the vaccine.
Data from the Phase 3 trial, including more than 40,000 adults aged 50 and older, showed that the mRNA vaccine was about 27 percent more effective against seasonal flu than a standard flu shot. A small Phase 3 trial, which included data from about 3,000 people age 65 and older, showed the shot produced a stronger immune response than the higher-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 conducted,” VRBPAC voting member and pediatric infectious disease expert Flor Munoz-Rivas of 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 enthusiasm for the agile mRNA platform for the flu vaccine, which is based on the same platform that Moderna used to develop its mRNA COVID-19 vaccines. In addition to improved efficacy, this allows “rapid development of vaccines in response to regular seasonal flu activity” and makes us “better prepared for emerging strains or pandemic strains in the future,” she said.
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