The U.S. Food and Drug Administration (FDA) has approved the first flu vaccine built on messenger RNA (mRNA) technology, months after the agency refused to even consider the application.
The shot, called mFLUSIVA, is made by Moderna and was cleared Wednesday, The New York Times reports.
Approval covers adults ages 50 to 64. Adults 65 and older fall under an accelerated approval, which permits broad use now and can be upgraded to a full approval if a follow-up study delivers acceptable results, The Times reported.
Moderna expects doses to be ready for the 2026-27 respiratory virus season.
The route to approval was unusual. Earlier this year, the FDA declined to review the application at all — a rare move against a large drugmaker that had run a big, largely favorable trial, according to The Times.
The refusal came from Dr. Vinay Prasad, then head of the agency’s vaccine division, who argued that Moderna had tested its shot against a GSK vaccine not regarded as best in class, tilting the comparison in the company’s favor.
Public criticism followed, and then-FDA Commissioner Dr. Marty Makary walked back the refusal, describing it as part of the agency’s ongoing dialogue with manufacturers. A review began soon after, The Times reported.
The clearance also lands after a rough stretch for mRNA research under Health Secretary Robert F. Kennedy Jr., including the cancellation of 22 mRNA vaccine projects at the Biomedical Advanced Research and Development Authority.
As a vaccine activist in 2021, Kennedy petitioned the FDA to pull mRNA COVID vaccines from the market six months into their rollout, The Times reported.
mRNA vaccines direct cells to build a small piece of a virus, which sets off an immune response.
The same approach powered COVID vaccines given to hundreds of millions of people. Two scientists won a Nobel Prize in 2023 for the underlying work.
For influenza, speed matters. Conventional flu shots take months to produce, and some still require growing the virus in fertilized chicken eggs.
“Having a flu vaccine that does not have to go through the archaic process of using chickens and eggs will benefit the public health enormously,” Dr. Georges Benjamin, chief executive of the American Public Health Association, told The Times.
“It will allow us to rapidly adjust to rapidly emerging new flu strains, a capacity we have not had before,” he added.
Moderna says the faster process could end the practice of selecting a single flu strain for an entire hemisphere each season, letting individual countries pick the best match.
Flu kills more than 300,000 people worldwide each year.
The 2024-25 U.S. flu season was especially harsh, with an estimated 45,000 deaths, according to the U.S. Centers for Disease Control and Prevention.
The FDA approval of the first mRNA flu vaccine represents an important advance in influenza prevention, but accessibility remains a challenge. A new vaccine can expand the prevention toolkit, but it won’t eliminate disparities if patients – particularly those from underserved communities – cannot access it, clinicians don’t routinely offer it, insurance coverage is unclear, or communities don’t trust the information they’re receiving.
For Black patients, who have historically experienced disparities in flu vaccination and hospitalization, ensuring equitable access and clear, culturally responsive communication will be especially important.
More information
Visit the U.S. Centers for Disease Control and Prevention for more information about preventing the flu.
SOURCE: The New York Times, Aug. 5, 2026
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