FDA Approves the First mRNA Flu Vaccine —NurPhoto / Contributor—Getty Images On Aug. 5, the U.S. Food and Drug Administration (FDA) approved the first mRNA-based vaccine for influenza. Health experts say the shot, made by Moderna, could have several advantages over traditional flu vaccines, but its approval comes at a time when federal health agencies have walked back recommending flu vaccines for many people. 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. “I think this is a historic event and incredibly exciting, both scientifically and from a public-health standpoint,” says Dr. Jeanne Marrazzo, CEO of the Infectious Diseases Society of America. “Flu remains a significant public health challenge, and mFlusiva provides an important new option for America’s seniors,” said Stéphane Bancel, Moderna’s CEO. Marrazzo says the mRNA-based flu vaccine is a gamechanger when it comes to mat
ching influenza strains circulating at a given time and in a given region to the flu vaccine. The better the match, the more effective the shot in preventing flu and some of its serious consequences, including pneumonia, respiratory distress, and even organ failure in those who are most vulnerable to infections, which include older people, young children, and those with weakened immune systems. 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 requir