The U.S. Food and Drug Administration on Wednesday approved the first mRNA-based flu vaccine for adults 50 and older.
The approval of the vaccine, called mFLUSIVA, is authorized for adults ages 50 to 64, The New York Times reported. The FDA also issued an accelerated approval for adults 65 and older, which allows widespread use, according to the newspaper. Moderna said it would commit to further study the shot in older adults in a post-marketing study, The Washington Post reported.
A price was not immediately available, according to the newspaper.
The new vaccine was found to be about 27% more effective during the 2024–25 respiratory virus season than standard flu shots in Moderna’s study, according to CNN. The study involved more than 40,000 adults 50 and older.
According to the cable news outlet, side effects of the vaccine included pain, tenderness and swollen lymph nodes; fatigue; headache; muscle or joint pain; nausea or vomiting; and fever.
Moderna officials said they expected to have the vaccine ready in time for the 2026-27 respiratory virus season, the Times reported.
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” Stéphane Bancel, Moderna’s chief executive, said in a statement. “This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
Scientists believe that mRNA technology offers a faster option than traditional flu vaccine options. Current vaccines take several months to prepare using decades-old technology, with some of them requiring the virus to develop in fertilized eggs, the Times reported.
“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 C. Benjamin, the chief executive of the American Public Health Association, told the newspaper. “It will allow us to rapidly adjust to rapidly emerging new flu strains, a capacity we have not had before.”
In February, the FDA initially declined Moderna’s request for review of the new flu vaccine, according to CNN. The agency cited inadequate trials, but changed its mind about two weeks later and agreed to review the shot.
Moderna's global headquarters is located at 325 Binney Street in Cambridge, Massachusetts.