Moderna Says FDA Will Consider New Flu Shot After Dispute Resolution

Vaccine maker reaches compromise with FDA on clinical trial design for mRNA-based flu vaccine for older adults.

Published on Feb. 21, 2026

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Moderna announced that the Food and Drug Administration will consider approving its new mRNA-based flu vaccine for older adults after the two sides resolved a public dispute over the design of the clinical trial. Moderna said it will seek 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

The dispute between Moderna and the FDA highlighted the heightened scrutiny that vaccines, particularly those using mRNA technology, have faced under the current administration. The resolution allows Moderna's novel flu shot to potentially reach the market, providing an additional option for older adults who are at higher risk of flu complications.

The details

Moderna's new flu vaccine was found to be more effective in adults age 50 and older compared to a standard flu shot in a 40,000-person clinical trial. However, the FDA initially refused to review the application, faulting 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 will now seek full approval for the 50-64 age group and accelerated approval for those 65 and older, with an additional study once the vaccine is on the market.

  • Moderna announced the change on February 18, 2026.
  • The FDA is targeting an approval decision by August 5, 2026.

The players

Moderna

A vaccine maker that developed a new mRNA-based flu shot for older adults.

Food and Drug Administration (FDA)

The U.S. government agency responsible for reviewing and approving new vaccines and drugs.

Dr. Vinay Prasad

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

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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 heightened scrutiny that new vaccine technologies, particularly mRNA-based shots, have faced from regulators in recent years. The resolution allows Moderna's novel flu vaccine to potentially reach the market, providing an additional option for older adults who are at higher risk of flu complications.