FDA Nears Decision on Groundbreaking mRNA Flu Vaccine

Moderna is seeking Food and Drug Administration approval of its new shot , dubbed mFlusiva, as an option for people 50 and older. The FDA advisory committee meeting is a step toward a final decision ahead of the winter flu season.

Tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable. There are various types of flu vaccines already available in the U.S., including three specifically recommended for people 65 and older. But vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types — something experts say might help if the shape-shifting flu virus mutates in a way that requires suddenly brewing new doses to match.

In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared to those given another routinely used vaccine brand. Ahead of the meeting, FDA published a favorable review of that data and reported no safety concerns.

Moderna is seeking full approval for the vaccine’s use in the 50- to 64-year-old population — along with authorization for use in those 65 and older while it conducts additional testing. If the vaccine is cleared for use, Moderna plans a follow-up study of 400,000 people 65 and older, half given the mRNA version and the rest given today’s senior-targeted flu vaccines.

Moderna’s Dr. Rituparna Das told panelists that the company’s ability to quickly manufacture mRNA vaccines that closely match the latest flu strains could prevent thousands of hospitalizations in older Americans.

Severe flu cases in the U.S. generally rise in years when the flu shot doesn’t closely match the circulating virus. Moderna officials said flu strains for the fall vaccines now are chosen in February -- several months sooner than the yearly recipe update for COVID-19 shots that mostly are mRNA-based — and there can be a mismatch if the flu virus mutates after the recipe is made.

At the meeting, FDA vaccine reviewer Dr. Timothy Brennan suggested the agency was open to approving the vaccine for seniors ahead of the coming flu season, despite gaps in data.

Earlier this year, Moderna’s data was at the center of a highly unusual public dispute as a then-top FDA official blocked the company’s application for its first-of-its-kind shot.

The embattled vaccine chief at the time, Dr. Vinay Prasad, said the company should have compared its shot to a high-dose flu vaccine recommended for seniors rather than a standard-dose brand. It was a sign of FDA’s heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr.

Moderna challenged that decision, noting that FDA staff had approved that main study’s design and citing a separate, smaller study comparing the mRNA shot with a high-dose vaccine for seniors. Days after the spat, the FDA accepted Moderna’s application.

The expert panel also will assess that smaller study, which found Moderna’s shot generated flu-fighting antibodies similarly to a high-dose senior shot. The FDA’s initial review noted the new vaccine lacks data on very frail older adults and those with weak immune systems.