FDA panel approves first mRNA flu vaccine; final decision in August

The Food and Drug Administration’s independent advisory committee recently approved a new flu vaccine modeled on the same technology used in COVID-19 shots, despite the Trump administration’s decision last year to halt federal funding for future mRNA vaccine development.

The vaccine, intended for adults ages 50 to 64, is under consideration after the FDA’s Vaccines and Related Biological Products Advisory Committee approved it in a unanimous vote June 18. The FDA will consider the recommendation and make a final decision in early August.

Unlike a traditional egg-based flu vaccine, mFlusiva relies on messenger RNA, or mRNA, which carries protein instructions for human cells to produce an immune response. That helps the body recognize the protein as foreign and prepare to fight it. Traditional vaccines typically use a weakened or inactivated virus that the body then learns to recognize and attack.

An egg-based vaccine takes about six to eight months to produce, while an mRNA vaccine can be completed in one to two months, potentially allowing manufacturers to better match the shot to the flu strain circulating that year.

“This puts us in a position, since we have this technology available, to be better prepared for emerging [flu] strains or pandemic strains in the future,” Flor Munoz, a member of the advisory committee, said during the vote.

Moderna submitted the vaccine to the FDA in February, and the agency initially blocked it. After pushback, the FDA reconsidered and sent it to the advisory committee for review.

The move comes after Health and Human Services Secretary Robert F. Kennedy Jr. halted future federal funding for mRNA vaccine development in August 2025. Kennedy canceled nearly $500 million in federal funding for future mRNA vaccine research.

“MRNA only codes for a small part of the viral proteins, usually a single antigen,” Kennedy said in a video released in August. “One mutation, and the vaccine becomes ineffective. To replace the troubled mRNA programs, we’re prioritizing the development of safer, broader vaccine strategies, like whole-virus vaccines and novel platforms that don’t collapse when viruses mutate.”

However, the FDA still reviews mRNA vaccines submitted by private pharmaceutical companies, such as mFlusiva.

The advisory committee’s vote moves the mRNA flu vaccine one step closer to possible release this flu season. Testing on older and younger age groups will continue into the fall.

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