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Matzav

FDA Reverses Decision Not To Review Moderna’s New Flu Vaccine

Feb 18, 2026·2 min read

The Food and Drug Administration has changed its position and will now evaluate Moderna’s new influenza vaccine, the company announced Wednesday, reversing an earlier decision that stunned its leadership.

Just days ago, the agency informed Moderna that it would not proceed with reviewing the company’s updated flu shot, stating that the submission lacked sufficient supporting research. The unexpected move left Moderna’s president, Dr. Stephen Hoge, in “complete shock.”

In an exclusive interview with The NY Post, Hoge said he was “completely surprised and honestly pretty confused” after receiving the letter from Dr. Vinay Prasad.

The FDA’s decision to reconsider comes after The Post published an editorial cautioning that halting the final phase of the vaccine’s approval process could cost lives, warning that such a move might result in the deaths of “hundreds, maybe thousands, of senior citizens.”

To accelerate the process, Moderna had submitted a divided application. The company sought full approval for individuals between the ages of 50 and 64, while requesting accelerated approval for those 65 and older, with a commitment to carry out a follow-up study in older adults after the vaccine becomes available.

According to Moderna, the FDA has now established an August deadline to determine whether the vaccine will receive approval. Should the agency give the green light, older Americans could receive the new flu shot ahead of the 2026–2027 influenza season.

View original on Matzav