FDA Approves First mRNA Flu Vaccine, for Ages 50 and Up

The Food and Drug Administration has approved Moderna's mRNA-based vaccine against seasonal influenza for people 50 and older, the company said late Wednesday.

It is the first flu vaccine approved in the United States that uses the same technology as COVID-19 shots. The vaccine is called mFLUSIVA, and Moderna says it will be available "in a few weeks" — in time for the 2026-2027 respiratory virus season.

"The FDA approval of mFLUSIVA … demonstrates the continued strength and versatility of our mRNA platform," Moderna chief executive Stéphane Bancel said in a statement. "Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors."

Company research involving more than 40,000 people found the vaccine is safe and appears to produce stronger protection than traditional flu vaccines.

The decision was closely watched because of the Trump administration's hostility toward mRNA technology. President Trump embraced the technology during his first term to produce the COVID vaccines, an achievement widely praised as a medical triumph that saved millions of lives. But backlash against pandemic responses, including vaccine mandates, left the shots and the platform vilified by some and the focus of widespread misinformation.

Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine critic, has repeatedly condemned the vaccines. The administration also slashed funding for mRNA vaccine research and curtailed access to COVID vaccines.

The FDA initially refused even to consider reviewing Moderna's mRNA flu shot, but relented after backlash from the pharmaceutical industry and public health experts. The agency convened a panel of independent outside advisers in June, which voted unanimously to recommend approval.

Public health officials note other advantages: mRNA vaccines can be updated and produced far more quickly than standard vaccines, which could matter when a new strain emerges unexpectedly, as happened last flu season, or if a pandemic strain evolves.

"I think this is really a critical step forward in advancing influenza vaccine technology," said Michael Osterholm, an infectious disease expert at the University of Minnesota.

"The FDA is signaling openness to this platform, which has been a controversy and an issue," said Dr. Jeanne Marrazzo, chief executive of the Infectious Disease Society of America, calling it "a really promising product."

Critics were disappointed. "I really believe that this technology is just too new," said Dr. Brian Hooker, chief medical officer at Children's Health Defense, an anti-vaccine group once headed by Kennedy. "I just feel like the train is leaving the station, and we're not ready yet."