Company says FDA reverses decision to review Moderna's mRNA flu vaccine.

Source: CNN

Reported by: Ntiamoah Bernice Mantebea

February 18, 2026.

The United States Food and Drug Administration has changed its earlier decision and will now examine a new mRNA flu vaccine developed by Moderna, according to the drug company on Wednesday.

Roughly two weeks back, the FDA wrote a letter to Moderna refusing to take in the request to check its very first mRNA vaccine for seasonal flu. This was an uncommon step by the government agency, and it sparked worries about yet another problem for the mRNA technology, which some health officials in the Trump administration have criticized.

In the letter, the FDA explained to Moderna that the application lacked a proper "well-controlled" study because the comparison group didn't match the top standard of flu care available in the U.S. during the study's time, based on the letter Moderna shared online. The company said the FDA raised no issues about safety or how well it works.

Since then, Moderna held talks with the FDA and suggested an updated way to handle the approval, with separate paths for different age groups, as stated in a press release from the company.

Moderna is asking for complete approval for people aged 50 to 64, quick approval for those 65 and older, and a follow-up study required after launch to test it further in older adults, the press release explained.

"Talks with the company resulted in a new approval plan and a changed application, which the FDA has accepted," said Andrew Nixon, a spokesperson for the U.S. Department of Health and Human Services, in a statement. "The FDA will stick to its strict standards in the review and any licensing, just like with every product."

If the FDA gives the go-ahead, the vaccine could reach people ages 50 and up for the 2026-2027 flu season coming up.

Last week, Moderna pointed out that the FDA's first refusal didn't line up with feedback the agency had given before.

"We thank the FDA for the productive Type A meeting and for agreeing to move forward with reviewing our application," Moderna CEO Stéphane Bancel said in a statement. "If the FDA approves it, we're excited to launch our flu vaccine later this year, giving America's older adults a fresh choice to guard against the flu."