Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving 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 FDA’s advisory committee—known as VRBPAC for Vaccines and Related Biological Products Advisory Committee—pored over data and presentations on the vaccine, which is dubbed mRNA-1010 and branded as mFlusiva. The presentations included a review from FDA scientists, which was supportive of the vaccine.
Data from a Phase 3 trial including over 40,000 adults age 50 and older found the mRNA vaccine was around 27 percent more effective against seasonal flu than a standard flu shot. A smaller Phase 3 trial, involving data from nearly 3,000 people age 65 years and older, showed 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 that the studies that were presented today were very well conducted,” VRBPAC voting member Flor Munoz-Rivas, a pediatric infectious disease expert at Baylor College of Medicine, said after the vote. “They have very clear results that are very robust in terms of demonstrating that additional efficacy.”
She also expressed enthusiasm for the agile mRNA platform for the flu vaccine, which is based on the same platform Moderna used to develop its mRNA COVID-19 vaccines. In addition to the better efficacy, it allows for “rapid development of the vaccines in regular seasonal flu activity” and makes us “better prepared for emerging strains or pandemic strains in the future,” she said.
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Frequently Asked Questions
Independent FDA advisors voted 9-0 in support of approving Moderna's seasonal mRNA flu vaccine (mRNA-1010, branded mFlusiva), after a Trump appointee at the agency initially tried to block it from being reviewed.
A Phase 3 trial of over 40,000 adults 50 and older found the mRNA vaccine about 27 percent more effective against seasonal flu than a standard flu shot. A smaller trial of nearly 3,000 people 65 and older showed stronger immune responses than the high-dose flu vaccine recommended for that age group.
VRBPAC member Flor Munoz-Rivas said the studies were very well conducted with clear, robust results demonstrating additional efficacy, and praised the agile mRNA platform for rapid development against emerging or pandemic strains.
Yes. The safety profile of the vaccine was generally good, according to the data presented.
