FDA agrees to review Moderna mRNA flu vaccine in dramatic reversal
After initially rejecting Moderna’s application for review, the FDA will now consider the company’s mRNA flu shot
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The U.S. Food and Drug Administration will review the messenger RNA (mRNA) flu vaccine for approval, according to its manufacturer. Moderna. The decision is a dramatic U-turn for the agency, which just about a week ago publicly rejected Moderna’s application to review the shot.
When it initially rejected the application, the FDA said Moderna’s clinical trials were lacking. On Wednesday, Moderna said it had amended its application. While this reversal has been welcomed by vaccine manufacturers and public health experts alike, the incident is the latest example of the Trump administration’s undermining of vaccine science. Health and Human Services Secretary Robert F. Kennedy, Jr., whose department has jurisdiction over the FDA, is a well-known vaccine skeptic who has repeatedly criticized mRNA COVID vaccines.
HHS spokesman Andrew Nixon said in a statement that the FDA had discussions with the company, resulting in “a revised regulatory approach and a revised application, which the FDA accepted.”
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“The FDA will maintain its high standards during the review and potential licensure phases as it does with all products,” Nixon said.
William Schaffner, an infectious disease physician and professor at Vanderbilt University Medical Center, says the FDA’s decision to withdraw is “good news.”
He says, “It is important to give all candidate new vaccines a fairly equitable assessment. This is especially true for new mRNA-based vaccines as this technology is currently being used to create vaccines against a wide variety of diseases, including cancer.”
Moderna’s mRNA flu shot is based on the same technology as its Covid vaccine. mRNA Covid shots have been credited with saving millions of lives. “With these mRNA vaccines, the benefits outweigh the risks,” says Angie Rasmussen, a virologist at the University of Saskatchewan.
In these types of shots, mRNA — essentially the instruction manual for genes to make proteins — is injected into the body, where it teaches cells to recognize and attack viral proteins. Vaccines using mRNA are attractive prospects for protecting against flu and many other diseases, including cancer. They are easy to make quickly and highly flexible, meaning new vaccines can be rapidly created to respond to emerging viral variants.
“Having such a vaccine available for flu would be a major step forward in efforts to protect the health of individuals from potentially severe influenza,” says Robert Hopkins, medical director of the National Foundation for Infectious Diseases.
Additional reporting by Lauren J. Young.
Editor’s note (2/18/26): This article was updated after posting to include comments from Andrew Nixon, Angie Rasmussen and Robert Hopkins. This is a breaking news story and may be updated later.
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