In a study published in May 2026 in the New England Journal of Medicine that Moderna submitted to the FDA, the mRNA-based flu shot, called mFlusiva, was up to 27% more effective in preventing flu than any of four currently available flu shots. Among more than 40,000 people over age 50 who were randomly assigned to receive either mFlusiva or one of four existing flu shots, those who received a single dose of the mRNA flu vaccine were on average 27% less likely to have lab-confirmed influenza-like illness than those getting another type of flu shot.
“Flu remains a significant public health challenge, and mFlusiva provides an important new option for America’s seniors,” said Stéphane Bancel, Moderna’s CEO.
Because the mRNA technology relies on a genetic plug-and-play model, in which different genetic sequences for any virus or pathogen can be switched into the vaccine, the shot takes around six weeks to develop. Current flu vaccines, on the other hand, take up to six months to create because they require growing the influenza virus in eggs before the virus is processed into the vaccine to activate the proper immune response.
Moderna plans to have mFlusiva available in the fall as flu vaccine campaigns start, but only for a select group of people. The FDA approved the shot for people ages 50 and older, the group that recently-revised U.S. government guidelines say should be receiving flu shots every year. The current recommendations differ from previous guidelines, which advised that anyone six years and older, including pregnant women, should be vaccinated against both flu and COVID every year. While the CDC continues to make this recommendation on its website, in January, the Trump Administration revised this guidance for routine vaccination and instead shifted the decision to vaccinate to individual families and their physicians. Disagreeing with the change, many health organizations—including the American Academy of Pediatrics, the American Medical Association, and the American College of Obstetricians and Gynecologists—continue to recommend yearly flu shots for most people.
mFlusiva's road to approval exemplifies this now-fraught environment for vaccines in the U.S., after the FDA initially dropped it from review in February. The agency sent Moderna a “Refusal-to-File” letter, notifying the company that it would not review the vaccine and stating that the study did not provide a proper control arm against which to compare mFlusiva, and that using existing flu shots as comparators “does not reflect the best-available standard of care.” In prior discussions before submitting its request for approval, the FDA suggested that the company provide data comparing mFlusiva among those 65 years or older to higher dose flu vaccines for this older population, which is at higher risk of complications from flu. Moderna says it provided the additional data.
Marrazzo says she can’t think of another drug that experienced such about-face decisions from the FDA. “It’s hard to read as anything other than a political decision from above,” she says. “I don’t know for certain if that’s true, but that’s my supposition, if you trace back to Secretary [Robert F.] Kennedy’s overt hostility to mRNA vaccines. It’s a really good thing that there was a reconsideration and that science won out.” Kennedy, who heads the Department of Health and Human Services that oversees the FDA, is a longtime skeptic of vaccines. In 2025, he halted 22 projects, worth $500 million, focused on developing mRNA vaccines for respiratory diseases, including for pandemic flu.
Mixed signals from federal health authorities are contributing to confusion among the public, who are increasingly questioning the effectiveness and safety of vaccines, despite what scientists maintain is a strong track record of their benefit with relatively low risk. One of the reasons people are reluctant to get a flu shot is because of its sometimes weak effectiveness in protecting against symptoms. But an mRNA-based vaccine should improve on that since its shorter development time gives manufacturers a better chance of matching influenza strains in real time. “Will the public buy it? That’s another question entirely,” says Marrazzo.
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