FDA advisory committee backs Moderna's seasonal flu vaccine

An FDA advisory committee unanimously backed Moderna's seasonal flu vaccine on June 18, giving the company a major regulatory step forward in its bid to win approval for the first U.S. flu shot made with mRNA technology.

The Vaccines and Related Biological Products Advisory Committee said the vaccine's benefits outweigh its risks for adults ages 50 to 64 and for adults 65 and older. The recommendation is nonbinding, so the FDA still has to make the final decision.

Moderna is seeking full approval for use in adults 50 to 64 and authorization for use in adults 65 and older while it continues additional testing. The company has said it is still developing the broader evidence base for the vaccine, including a larger follow-up study if regulators ultimately sign off.

AP reported that Moderna's studies showed about a 27% reduction in flu cases versus a traditional vaccine in a study of about 40,000 people age 50 and older. Coverage said no major safety issue was reported in the reporting around the advisory committee review.

Regulatory path

The June vote followed an earlier dispute with the FDA over whether the agency would review Moderna's original application. Coverage in February reported that the FDA initially declined to consider the filing, then later agreed to review an amended application after a Type A meeting with the company.

That reversal put the vaccine back on the agency's review track and led to the advisory committee meeting in June.

The WSJ also reported that the FDA will consider the panel's recommendation as part of its ongoing biologics license review. Reported expectations point to a final decision by early August 2026.

Why it matters

If approved, the shot would be the first U.S. flu vaccine made with mRNA technology. That would be an important expansion for Moderna beyond its COVID-19 products and a significant test of whether mRNA can establish a larger role in seasonal influenza vaccines.

The technology is drawing attention because flu strain selection happens months before the season starts, and mRNA vaccines can be manufactured more quickly than traditional flu shots if circulating strains change later in the year.

Older adults are the main target group in Moderna's filing and also among the people at highest risk of flu complications. AP reported that the company is planning a larger follow-up study involving about 400,000 adults age 65 and older if the vaccine is approved.

What happens next

The FDA is not required to follow the committee's recommendation exactly, and the advisory vote does not amount to approval. The next major milestone is the agency's final decision, which coverage says is expected by early August.

After that, the key questions are whether the FDA approves both age groups exactly as recommended, whether it places any labeling limits or post-approval study requirements on the product, and how quickly Moderna can move toward launch.

Moderna's vaccine has also been accepted for regulatory review in the European Union, Canada and Australia, according to WSJ coverage, which underscores that the company is trying to turn the flu shot into a broader international platform.

For now, the advisory committee vote is the clearest signal yet that the company's mRNA flu program has cleared one of its biggest hurdles.

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