FDA to Consider Moderna's New Flu Shot After Public Dispute

Moderna says it has reached a compromise with the FDA to seek approval for its mRNA-based flu vaccine.

Feb. 21, 2026 at 6:23pm

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The FDA will now consider approving Moderna's new flu vaccine, resolving a public dispute that had previously blocked the company's application for the first-of-its-kind shot. Moderna announced the change, saying it is 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.

Why it matters

This case highlights the heightened scrutiny the FDA is placing on new vaccines, particularly those using mRNA technology, under the leadership of Health Secretary Robert F. Kennedy Jr. The public dispute between Moderna and the FDA's vaccine chief over the design of Moderna's clinical trial raises questions about the agency's approval process and its willingness to consider innovative vaccine approaches.

The details

The dispute centered over 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 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 shared additional comparison data from a separate trial.

  • Moderna announced the change on February 18, 2026.
  • The FDA is targeting a decision on Moderna's application by August 5, 2026.
  • Moderna hopes to make the vaccine available later in 2026.

The players

Moderna

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

FDA

The U.S. Food and Drug Administration, the federal agency responsible for regulating and supervising the safety of food, drugs, and medical devices.

Vinay Prasad, MD, MPH

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

Robert F. Kennedy Jr.

The U.S. Health Secretary, who has been critical of mRNA technology used in COVID-19 vaccines.

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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)

“Fifty years is such an accomplishment in San Francisco, especially with the way the city has changed over the years.”

— Gordon Edgar, grocery employee (Instagram)

What’s next

The FDA is targeting a decision on Moderna's application by August 5, 2026.

The takeaway

This case highlights the FDA's heightened scrutiny of new vaccines, particularly those using mRNA technology, under the leadership of Health Secretary Robert F. Kennedy Jr. The public dispute between Moderna and the FDA's vaccine chief raises questions about the agency's approval process and its willingness to consider innovative vaccine approaches.