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

Moderna's stock rises over 5% after FDA agrees to consider approving the new vaccine.

Published on Feb. 22, 2026

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The Food and Drug Administration (FDA) has agreed to review Moderna's new mRNA-based flu vaccine, resolving a dispute that had previously blocked the company's application. The FDA had initially refused to review the vaccine, citing issues with the clinical trial design, but has now agreed to consider full approval for adults aged 50-64 and accelerated approval for those 65 and older.

Why it matters

This decision is significant as Moderna's mRNA flu vaccine would be the first of its kind to reach the market. The use of mRNA technology in vaccines has faced heightened scrutiny from the current FDA leadership under Health Secretary Robert F. Kennedy Jr., making this reversal an important development.

The details

Moderna announced that the FDA will now consider its application for the new flu vaccine, which was more effective in adults 50 and older compared to standard flu shots. The FDA had previously issued a 'refusal to file' letter, citing issues with the clinical trial design. Moderna argued that the FDA had agreed to the trial design and that additional data was provided. As a compromise, Moderna is now seeking full approval for adults 50-64 and accelerated approval for those 65 and older, with an additional study once the vaccine is on the market.

  • The FDA is targeting an August 5th decision on Moderna's application.
  • Moderna hopes to make the vaccine available later this year.

The players

Moderna Inc.

A biotechnology company that developed the new mRNA-based flu vaccine.

Dr. Vinay Prasad

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

Robert F. Kennedy Jr.

The current Health Secretary who has faced criticism for his approach to regulating mRNA 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 judge in the case will decide on Tuesday whether or not to allow Walker Reed Quinn out on bail.

The takeaway

This case highlights growing concerns in the community about repeat offenders released on bail, raising questions about bail reform, public safety on SF streets, and if any special laws to govern autonomous vehicles in residential and commercial areas.