FDA Reverses Course, Will Review Moderna's Flu Vaccine

Moderna says agency will accept its application after initial rejection, setting August deadline for decision.

Feb. 21, 2026 at 11:07am

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The Food and Drug Administration has reversed its previous decision and agreed to review Moderna's new flu vaccine that uses mRNA technology. Moderna said the agency will now accept its application, which seeks traditional approval for the vaccine in people aged 50-64 and accelerated approval for those 65 and older. The FDA had initially rejected Moderna's application, citing concerns over the control vaccine used in the company's study, but the two sides have since held further discussions.

Why it matters

The FDA's reversal is a significant development, as the approval of Moderna's mRNA-based flu vaccine would mark a major milestone for the emerging vaccine technology. It also comes amid broader tensions between the Biden administration and some health officials over the use of mRNA vaccines, which have been the subject of criticism from Health Secretary Robert F. Kennedy Jr.

The details

Moderna said it split its application for the flu vaccine based on age, seeking traditional approval for people 50 to 64 years old and accelerated approval for those 65 and older. The company also agreed to conduct an additional study among those 65 and older once the vaccine reached the market. The FDA set an August deadline to decide whether to approve the vaccine, which if authorized would be available for older adults in the upcoming flu season.

  • On February 18, 2026, the FDA reversed its previous decision and agreed to review Moderna's flu vaccine application.
  • The FDA set an August 2026 deadline to decide whether to approve Moderna's flu vaccine.

The players

Moderna

A biotechnology company that developed a COVID-19 vaccine using mRNA technology and is now seeking approval for an mRNA-based flu vaccine.

Food and Drug Administration (FDA)

The U.S. government agency responsible for regulating and supervising the safety of food, drugs, and other products, including vaccines.

Robert F. Kennedy Jr.

The current U.S. Secretary of Health, who has repeatedly criticized mRNA vaccines as unsafe and ineffective.

Dr. Vinay Prasad

The FDA's top vaccine official who initially rejected Moderna's flu vaccine application, citing concerns about the control vaccine used in the company's study.

Dr. Marty Makary

The FDA commissioner who briefly referred to the agency's previous rejection of Moderna's flu vaccine application at an industry event.

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What they’re saying

“The current uncertainty in the U.S. F.D.A. regulatory environment creates real challenges for businesses, patients and the broader innovation ecosystem.”

— Stéphane Bancel, Chief Executive, Moderna (Moderna earnings call)

“I want to see more kids get vaccinated.”

— Dr. Marty Makary, FDA Commissioner (PhRMA event)

What’s next

The FDA is set to decide whether to approve Moderna's flu vaccine by August 2026, which would make the vaccine available for older adults in the upcoming flu season.

The takeaway

The FDA's reversal on reviewing Moderna's mRNA-based flu vaccine application marks a significant development in the ongoing debate over the use of this emerging vaccine technology. The approval of Moderna's flu shot could pave the way for greater acceptance of mRNA vaccines, despite continued skepticism from some health officials.