Federal vaccine advisers unanimously recommended approval of Moderna’s influenza vaccine, which would become the first flu shot in the United States to use mRNA technology.
By yourNEWS Media Newsroom
A Food and Drug Administration advisory panel voted unanimously June 18 to recommend approval of Moderna’s messenger ribonucleic acid influenza vaccine for adults 50 and older, moving the United States closer to its first mRNA flu shot.
The Vaccines and Related Biological Products Advisory Committee said clinical trial data showed the vaccine was effective against influenza and did not reveal safety concerns that would prevent approval. The FDA usually follows the panel’s recommendations, though it is not required to do so.
“The presented data do indicate efficacy against flu with no safety signals,” said Dr. Hana El Sahly, a professor at Baylor College of Medicine and a committee member who worked on a Moderna COVID-19 vaccine trial.
Dr. Hayley Gans, a pediatrics professor at Stanford Medicine Children’s Health and another committee member, said the technology could help modernize future vaccines.
“I think that this particular platform adds exciting ways that we can actually move our vaccines to the future,” Gans said.
The recommendation was based on data from multiple clinical trials, including one involving 40,000 participants. In that trial, Moderna’s shot was 26.6% more effective at preventing influenza than a standard flu vaccine already on the market.
Influenza-like illness occurred in 2.0% of Moderna vaccine recipients, compared with 2.8% of participants who received the standard flu shot. Adverse reactions were higher among people who received Moderna’s vaccine.
Some former FDA officials had previously raised concerns about the trial design because it did not compare Moderna’s product with a high-dose flu vaccine. The Centers for Disease Control and Prevention currently recommends high-dose influenza vaccines for older adults.
Moderna executives said Thursday that the standard comparator vaccine was selected for several reasons, including its historical use as a benchmark in flu vaccine testing. They also said a separate study comparing immune responses among older adults against a high-dose vaccine provided additional support for authorization.
If the FDA accepts the advisory panel’s recommendation, Moderna’s vaccine would receive traditional approval for adults ages 50 to 64. Traditional approval requires substantial evidence that a product is safe and effective.
For adults 65 and older, regulators would grant accelerated approval. That pathway is used for products that address an unmet medical need and are reasonably likely to predict clinical benefit.
Accelerated approval would require Moderna to conduct a post-approval trial. Company executives said Thursday that the follow-up study is expected to enroll 400,000 people.
Moderna executives argued that the performance of existing flu vaccines shows a continuing unmet medical need. According to a CDC presentation, available influenza vaccines were estimated to be 11% to 46% effective among children and 23% to 34% effective among adults in late 2025 and early 2026. Historically, flu vaccine effectiveness has ranged from 19% to 60%.
Influenza typically circulates during fall and winter. Each spring, officials try to predict which strains will spread during the next flu season, giving manufacturers roughly six months to produce updated shots before vaccinations begin in early fall.
That system can lead to a mismatch between the strains targeted by vaccines and the strains that ultimately circulate. FDA officials and Moderna said an mRNA platform could help address that problem by allowing faster updates.
The potential approval would expand the use of mRNA vaccines beyond COVID-19 and respiratory syncytial virus. Vaccines using mRNA are already cleared in the United States for both conditions.
There are currently nine approved influenza vaccines in the United States, none of which use mRNA technology.
While panel members supported the Moderna vaccine, the product’s higher rate of adverse reactions compared with existing flu vaccines remains a consideration for regulators and clinicians.
The FDA will now decide whether to grant approval for Moderna’s mRNA influenza vaccine and under what terms, including post-approval requirements for older adults covered under the accelerated approval pathway.
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