The U.S. Food and Drug Administration approved an mRNA-based vaccine for influenza. Live Science asked experts what that means for the future of mRNA vaccines in the U.S.
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The U.S. Food and Drug Administration (FDA) recently approved the first mRNA vaccine for seasonal influenza, bringing a bumpy approval process to a close.
The shot's approval appears to contradict the federal government's generally unfavorable view of mRNA vaccines. The U.S. Department of Health and Human Services (HHS) terminated half a billion dollars in funding for mRNA vaccine development, impacting 22 projects. A key vaccine advisory committee was remade to include people who have been vocally opposed to mRNA vaccines. Health Secretary Robert F. Kennedy Jr. has falsely called the mRNA-based COVID-19 shots the "deadliest vaccines ever made" and incorrectly claimed that mRNA vaccines don't work well against upper-respiratory viral infections.
Does the approval of a new mRNA vaccine signal a shift in this sentiment? Not necessarily, experts told Live Science.
"I don't read this as a shift in the administration's stance on mRNA," Jeff Coller, a distinguished professor of RNA biology and therapeutics at Johns Hopkins University, said in an email. Coller is also a co-founder of the Alliance for mRNA Medicines, an international association aimed at advancing mRNA technology, and he advises several RNA companies.
The approval does suggest, however, that the FDA's approval process isn't completely compromised by anti-mRNA sentiment, Coller said.
"What the approval does signal, and I think this is the more useful story: the statutory machinery still works when it is allowed to run," Coller said. "For companies and investors deciding whether to keep building in this space in the United States, that matters more than any statement from HHS."
The new flu vaccine, called mFlusiva, was made by Moderna. The company filed for the shot's approval in February, but initially, the FDA denied Moderna's request to have its materials reviewed.
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Reporting by STAT News later found that career FDA scientists had planned to do the review but they had been overruled by Dr. Vinay Prasad, then director of the FDA's Center for Biologics Evaluation and Research (CBER). (Live Science has contacted the FDA for comment.)
"It's been a little tortured," Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said of the approval process. In April 2024, before starting its final trial of the vaccine, Moderna ran its plans past the FDA, and the FDA confirmed in writing that the trial's design was acceptable. But when Moderna filed for approval using data from the trial, "Vinai Prasad, who had just been put in place at CBER … said no," Offit told Live Science.
"That didn't last long, nor did he last long, after that," Offit added. The denial was reversed within the month, and Prasad left the FDA in April.
"That refusal was reversed fifteen days later," Coller said. "Nothing about the evidence changed in those fifteen days." What changed were the choices made by FDA leadership, he said.
Once allowed to do so, the FDA's vaccine advisory committee, called the Vaccines and Related Biological Products Advisory Committee (VRBPAC), met to discuss the shot's safety and effectiveness. The group voted unanimously to recommend approving the vaccine for adults ages 50 and up. The FDA then followed this advice, making the approval official.
