Federal vaccine advisors unanimously supported Moderna’s experimental mRNA flu shot on Friday, concluding months of internal conflict at the Food and Drug Administration that almost halted the review.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 9–0 after an all-day meeting to recommend mRNA-1010, branded as mFlusiva. Agency scientists and Moderna presented data showing the shot performed better than traditional flu vaccines in trials.
A Phase 3 study involving over 40,000 adults aged 50 and older found the vaccine was 27% more effective than standard options. Another trial with nearly 3,000 participants aged 65 and above demonstrated stronger immune responses compared to the high-dose flu vaccine currently recommended for seniors. Side effects remained mild, with no significant safety issues reported.
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“The studies were well conducted,” said Flor Munoz-Rivas, a pediatric infectious disease specialist at Baylor College of Medicine and a committee member. “The results clearly show additional efficacy.”
Committee members highlighted the mRNA platform’s adaptability. Traditional flu vaccines depend on growing viruses in eggs or cells, but mRNA technology enables quicker updates to match circulating strains. This flexibility could be vital during pandemics or when new flu variants appear mid-season.
A Trump-appointed FDA official initially blocked the vaccine from reaching the advisory committee. Moderna described the rejection as unexpected, noting it occurred despite opposition from agency scientists and staff. The FDA reversed its stance within a week, allowing the review to move forward.
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Moderna welcomed the committee’s vote. “We value the careful review by VRBPAC and their acknowledgment of the clinical evidence,” CEO Stéphane Bancel said. “mRNA-1010 could offer a valuable new option for seasonal flu prevention.”
The FDA usually follows the committee’s advice but isn’t required to do so. The agency has until August 5 to make a final decision. If approved, Moderna plans to release the vaccine later this year.
Another challenge remains before the shot reaches patients. The Centers for Disease Control and Prevention must review new vaccines through its Advisory Committee on Immunization Practices, which issues recommendations that determine insurance coverage. Federal law requires most insurers to cover ACIP-recommended vaccines without patient costs.
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ACIP’s status is now unclear. A federal judge removed nearly all committee members after ruling they were improperly appointed by Robert F. Kennedy Jr., the vaccine skeptic now leading the Department of Health and Human Services. Many of the removed advisors share Kennedy’s doubts about vaccines and mRNA technology. The Biden administration is appealing the ruling, but a resolution isn’t expected until July at the earliest.
Without ACIP’s support, the vaccine’s launch could face delays or reduced adoption. Its success may depend on whether the CDC can rebuild a functional advisory group before flu season begins.
Complexity in regulatory systems often creates unexpected obstacles.
