Moderna Reaches Compromise with FDA on New Flu Vaccine

Company to seek full approval for adults 50-64, accelerated approval for 65+

Published on Feb. 22, 2026

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The Food and Drug Administration will consider whether to approve Moderna's new flu vaccine after the company reached a compromise with the agency. The dispute had previously blocked Moderna's application for the first-of-its-kind shot made with mRNA technology.

Why it matters

This resolution allows Moderna to potentially bring a new flu vaccine option to market, which could provide improved protection, especially for older adults who are more vulnerable to severe flu illness. The dispute also highlighted the FDA's heightened scrutiny of mRNA vaccines under the current administration.

The details

The dispute centered around a 40,000-person clinical trial that concluded Moderna's new vaccine was more effective in adults age 50 and older than one of the standard flu shots used today. The FDA's vaccine director initially faulted the trial for not including another brand specifically recommended for people 65 and older. Moderna objected, saying the FDA had agreed to the study's design and that the company provided additional comparison data. As a compromise, Moderna is now seeking full approval for the vaccine's use in adults 50 to 64 and accelerated approval for those 65 and older, with an additional study once the shot is on the market.

  • Moderna announced the resolution on February 18, 2026.
  • The FDA is targeting an approval decision by August 5, 2026.
  • Moderna hopes to make the vaccine available later in 2026.

The players

Moderna Inc.

A biotechnology company that develops vaccines and therapeutics, including the first-of-its-kind flu vaccine made with mRNA technology.

Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and medical devices in the United States.

Dr. Vinay Prasad

The FDA's vaccine director who initially refused to review Moderna's new flu vaccine application.

Robert F. Kennedy Jr.

The current U.S. Health Secretary who has been critical of mRNA vaccines and has overseen changes to the FDA's approach to vaccine recommendations.

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What they’re saying

“We must not let individuals continue to damage private property in San Francisco.”

— Robert Jenkins, San Francisco resident (San Francisco Chronicle)

What’s next

The FDA is targeting an approval decision on Moderna's new flu vaccine by August 5, 2026.

The takeaway

This case highlights the FDA's heightened scrutiny of mRNA vaccines under the current administration and the challenges companies may face in bringing innovative vaccine technologies to market, even when they appear to meet clinical trial endpoints. The resolution allows Moderna to potentially provide a new flu vaccine option, which could improve protection for vulnerable older adults.