FDA advisers vote unanimously to approve Moderna’s mRNA after agency drama

The Food and Drug Administration’s independent advisers on Friday voted 9-0 in favor of approving Moderna’s early-stage mRNA vaccine, which Trump’s appointees to the agency initially tried to block from review.

During the day-long meeting, members of the FDA’s advisory committee, called VRBPAC for Vaccines and Related Biological Products Advisory Committee, analyzed information and specifications about the vaccine, which is called mRNA-1010 and is called mFlusiva. The presentation also included commentary from FDA scientists, who were supporters of the vaccine.

Data from Phase 3 trials including more than 40,000 adults age 50 and older found that the mRNA vaccine was more effective against seasonal flu than the flu shot. A small Phase 3 trial, involving data from about 3,000 people aged 65 and over, showed that the shot produced stronger immune responses than the flu vaccine, which is recommended for this age group. The safety record of the vaccine was generally good.

“I think the education presented today was 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 showing the need for that supplement.”

He also expressed interest in a stable mRNA platform for a flu vaccine, which is based on the platform Moderna used to develop the mRNA COVID-19 vaccine. In addition to being more effective, it will enable “rapid development of vaccines in routine influenza situations” and make us “better prepared for future challenges or pandemic challenges in the future,” he said.