FDA advisers back Moderna mRNA flu vaccine for older adults

A Food and Drug Administration advisory committee voted Thursday to recommend approval of Moderna’s mRNA flu vaccine for older adults, NBC News reported. If regulators clear the shot, called mFlusiva, it would become the first messenger RNA flu vaccine approved anywhere in the world.

The vote matters because flu vaccine makers must now choose target strains months before each season, and the virus can change before shots reach patients. Moderna told the FDA panel its mRNA shot could move from strain selection to rollout in two to three months, compared with about six months for traditional flu vaccines, according to NBC News.

The recommendation came from the FDA’s Vaccines and Related Biological Products Advisory Committee. NBC News reported that the panel backed approval for adults ages 50 to 64 and for adults 65 and older, while saying Moderna should conduct another clinical trial after the vaccine is on the market for the older group.

Moderna’s application still has several steps ahead. The FDA must decide whether to approve the vaccine, and the Centers for Disease Control and Prevention’s advisory committee would need to formally recommend it before Americans could receive it this fall, NBC News reported. That CDC panel has been prevented from meeting by a federal judge, according to the report.

In a late-stage trial, Moderna’s vaccine was about 27% more effective than a standard flu shot, NBC News reported. FDA officials had questioned the design of the company’s study in adults 65 and older because Moderna compared its product with a standard-dose flu vaccine, while the CDC recommends high-dose flu shots for that age group.

Moderna said the FDA had previously agreed to the study design, according to NBC News. The agency initially declined earlier this year to review Moderna’s application, then changed course about a week later, NBC News reported.

Dr. Lisa Grohskopf, a medical officer in the CDC’s flu division, told the FDA panel that hundreds of thousands of people in the United States are hospitalized with flu each year, NBC News reported. Older adults account for most of those hospitalizations, she said.

Several flu vaccines are already sold in the United States, but their performance changes from season to season. NBC News reported that mRNA technology could give public health officials more flexibility because manufacturers may be able to adjust vaccines later in the year to better match circulating strains.

Dr. Jesse Goodman, a former FDA chief scientist and infectious disease specialist at Georgetown University Medical Center, told NBC News that the ability to modify a flu vaccine later than egg-based vaccines could allow shots to be more current. mRNA vaccines work by using genetic instructions to help the body recognize the virus; the mRNA then breaks down and does not remain in the body, according to NBC News.

The review is taking place while the Department of Health and Human Services, which oversees the FDA, has taken a skeptical stance toward mRNA vaccines under Health Secretary Robert F. Kennedy Jr., NBC News reported. Kennedy has called the mRNA Covid vaccine “the deadliest vaccine ever made,” and HHS last year canceled nearly $500 million for mRNA vaccine research, according to NBC News.

The FDA also lacks a permanent commissioner and a permanent vaccine chief, NBC News reported. Karim Mikhail is acting head of the agency’s vaccine division after Dr. Vinay Prasad’s April departure, and Kyle Diamantas is acting commissioner after Dr. Marty Makary resigned in May, according to the report.

Dorit Reiss, a vaccine policy expert at the University of California Law San Francisco, told NBC News that the FDA does not always follow its advisory panels but should judge the vaccine by the data. NBC News reported that the agency has twice approved annual updates to mRNA Covid vaccines since 2025.

This story draws on original reporting from NBC News.