FDA Reverses Course, Will Review Moderna's New mRNA Flu Vaccine

The back-and-forth highlights the White House's skepticism of mRNA technology.

Published on Feb. 24, 2026

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The FDA has agreed to review Moderna's new flu vaccine that uses mRNA technology, reversing its previous refusal to do so. Moderna said it tweaked its application after meetings with regulators, specifically regarding trials for older adults. The FDA will issue its decision on the new flu shot in August, ahead of this year's flu season.

Why it matters

The reversal highlights the ongoing debate around mRNA vaccines, with the White House expressing skepticism about the technology despite its success in the COVID-19 vaccine. The approval of Moderna's new flu shot could have significant implications for the future of mRNA-based vaccines.

The details

Moderna said it tweaked its application after meetings with regulators, specifically regarding its trials for older adults. The FDA will issue its decision on the new flu shot in August, ahead of this year's flu season. At the heart of the back and forth is the White House's beef with mRNA vaccines. Health Secretary Robert F. Kennedy Jr. has questioned the safety of mRNA technology, and some vaccine researchers using federal funds said they were told to remove any references to mRNA on grants last year.

  • Moderna said it tweaked its application after meetings with regulators.
  • The FDA will issue its decision on the new flu shot in August, ahead of this year's flu season.

The players

Moderna

A pharmaceutical company that developed a COVID-19 vaccine using mRNA technology.

Food and Drug Administration (FDA)

The government regulatory body that will review and decide on Moderna's new flu vaccine.

Robert F. Kennedy Jr.

The Health Secretary who has expressed skepticism about the safety of mRNA vaccines.

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What they’re saying

“Moderna's stock jumped over 6% after the reversal. The company is hoping to break even by 2028—a goal that hinges on smooth approval of its new drugs, including a Covid–flu combo shot.”

— MM (morningbrew.com)

What’s next

The FDA will issue its decision on Moderna's new mRNA flu vaccine in August, ahead of this year's flu season.

The takeaway

The back-and-forth over Moderna's new mRNA flu vaccine highlights the ongoing debate around this emerging technology, with the White House expressing skepticism despite its success in the COVID-19 vaccine. The FDA's approval of this new flu shot could have significant implications for the future of mRNA-based vaccines.