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FDA advisors unanimously vote to approve Moderna's mRNA after agency drama
In February, a Trump official refused to review the vaccine.
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.
Fellow voting member Hayley Gans, a pediatric infectious disease expert at Stanford University, agreed. “I think that this particular platform adds exciting ways that we can actually move our vaccines to the future,” she said. “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 really what it can do for our vaccine platform. … This one has the potential to really move us in a modern direction.”
The outcome today is in stark contrast to a few months ago, when Trump official Vinay Prasad was overseeing vaccines at the FDA. In a shocking decision in February, Prasad rejected Moderna’s filing, refusing to even review the vaccine. Prasad claimed that the large vaccine trial was not “adequate and well-controlled” because it did not compare efficacy to a high-dose vaccine in people 65 and older. Instead, Moderna used the smaller trial to compare immune responses of mRNA-1010 to a high-dose vaccine—which was a plan the FDA had previously agreed would be acceptable.
Moderna was blindsided by the refusal, which Prasad issued over the objections of FDA scientists and career officials. Amid widespread outcry, the FDA reversed the decision the next week, agreeing to review the vaccine. Around the same time, Prasad was also behind the rejection of a closely watched gene therapy for Huntington’s disease made by UniQure, which was widely criticized and called “truly evil” by a former FDA official.
Prasad was pushed out of FDA at the end of April amid a string of decried decisions and controversies. Prasad’s decision on UniQure’s gene therapy was reversed on Wednesday.