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A first-of-its-kind flu shot is a step closer to being available to the public after a Food and Drug Administration (FDA) advisory panel voted Thursday to recommend Moderna’s mRNA-based vaccine for approval.
The FDA’s independent vaccine advisors voted unanimously 9-0 that the benefits outweigh the risks for Moderna’s mFlusiva shot in people ages 50 to 64 as well as 65 and older.
Moderna is seeking standard approval for its vaccine in the younger group and an accelerated approval in the latter. The company will be required to run an additional clinical trial after the vaccine reaches the market in the older group.
But the next steps are uncertain.
Advisory committee recommendations are non-binding, and the FDA needs to make a final decision on approval by Aug. 5. Currently, the FDA has no permanent vaccine chief nor a commissioner, so it’s not clear who will make the final decision on Moderna’s flu shot.
The vaccine then needs to be formally recommended by the Centers for Disease Control and Prevention’s (CDC) advisory committee, which a federal judge has blocked from meeting with its current membership.
Once the panel makes a recommendation, the CDC director will decide whether to adopt it, change it or reject it. CDC also has no permanent director; National Institutes of Health Director Jay Bhattacharya is the acting CDC director.
The flu kills tens of thousands of people a year, and older populations are most vulnerable. While there are currently vaccines on the market that specifically meant for older populations, they take longer to manufacture and are not as flexible as the mRNA platform in targeting a specific strain of virus.
“Having this technology available puts us in a better position to be prepared for emerging strains or pandemic strains in the future,” said panelist Flor Munoz-Rivas, an infectious disease specialist at Texas Children’s Hospital.
Currently, manufacturers must decide months in advance which strain they want the annual vaccine to target. That gives the virus time to evolve, potentially making the vaccine less effective.
Vaccines using mRNA can be developed much quicker and if needed, updated later in the year to better match the prevalent strain.
“I think that this particular platform adds exciting ways that we can actually move our vaccines to the future,” said panel member Hayley Gans, a professor of pediatrics at Stanford University Medical Center.
According to company data, Moderna’s vaccine reduced flu cases by about 27 percent compared with those from the standard dose vaccine in adults 50 and older.
In a smaller study of people ages 65 and older, the mRNA shot generated a strong protective immune response compared with an existing high-dose flu vaccine already recommended for that age group.
“We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010,” Moderna CEO Stéphane Bancel said in a statement. “We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review.”
The path to this FDA meeting has been fraught. A top FDA official initially refused to review the vaccine in February.
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.
Application refusals are rare, and critics said the episode pointed to a hostile environment for mRNA vaccines under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
Kennedy has called Moderna’s mRNA COVID shot “the deadliest vaccine ever made,” and last year HHS canceled nearly $500 million in funding for mRNA vaccine research.
Moderna challenged the refusal and FDA abruptly reversed course a week later.
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