The Food and Drug Administration on Wednesday approved Moderna’s mFlusiva, making it the first mRNA-based seasonal influenza vaccine authorized for use in the United States.
The agency approved the vaccine for adults ages 50 to 64 and granted accelerated approval for people 65 and older. Moderna will be required to conduct a postmarket clinical trial to confirm the vaccine’s effectiveness in the older age group.
The FDA’s approval was not a given. Earlier this year, then-FDA vaccine chief Dr. Vinay Prasad initially refused to review Moderna’s application.
A top FDA official earlier this year initially refused to review the vaccine before the agency reversed course a week later under pressure.
Former agency vaccine chief Vinay Prasad said the application was rejected because of Moderna’s decision to compare its vaccine to a standard flu shot in adults 65 and up, rather than the high-dose shot. Moderna said FDA had initially signed off on the trial design.
Application refusals are rare, and critics said the episode pointed to a hostile environment for mRNA vaccines under Kennedy.
The FDA’s independent vaccine advisory committee later voted unanimously that mFlusiva’s benefits outweighed its risks for adults ages 50 to 64. The panel also unanimously supported accelerated approval for those 65 and older.
The decision comes against a broader shift in vaccine policy under Health and Human Services Secretary Robert F. Kennedy Jr., who has been one of the federal government’s most prominent critics of mRNA technology.
Kennedy has called the COVID-19 vaccines “the deadliest vaccine ever made” and has questioned whether mRNA shots provide meaningful protection against respiratory infections.
On Aug. 5, 2025, HHS announced that it was canceling or scaling back 22 mRNA vaccine-development projects worth nearly $500 million. Kennedy said the department was moving funding toward what he described as safer and broader vaccine platforms.
Kennedy has also said he stopped receiving annual flu shots in 2005 because of concerns about possible side effects.
Health and Human Services Secretary Robert F. Kennedy Jr. told USA TODAY he stopped taking flu shots in 2005 because of his concerns about side effects, including suspicions about what damaged his voice.
Kennedy, 71, said he got annual flu shots through the mid-1990s. But he said he gave them up for good in 2005 as he became more aware of possible side effects.
His vaccine advisers have continued to support annual flu vaccination for nearly everyone six months and older, although the panel last year recommended using only thimerosal-free formulations.
MFlusiva must still move through the Centers for Disease Control and Prevention’s recommendation process before it is likely to receive routine insurance coverage.
The CDC’s Advisory Committee on Immunization Practices ordinarily determines which populations should receive newly approved vaccines. A federal judge, however, has blocked the panel from meeting under its current membership, leaving the timing of a formal recommendation uncertain.
READ MORE: Senate Confirms Trump Nominee Dr. Erica Schwartz As CDC Director
Doctors could prescribe mFlusiva without an ACIP recommendation, but insurers would not necessarily be required to cover it.
The issue will now fall partly to the CDC’s newly confirmed director, Dr. Erica Schwartz. The Senate confirmed Schwartz on Wednesday by a 51-44 vote after lawmakers pressed her on whether she would resist political interference in vaccine decisions.
Schwartz told senators that she “will never betray the science.”
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