FDA Rejects Moderna’s Application for mRNA Flu Shot

The Food and Drug Administration is refusing to review Moderna’s experimental influenza vaccine, the company announced on Feb. 10.

In a letter published by Moderna, FDA Center for Biologics Evaluation and Research (CBER) Director Dr. Vinay Prasad wrote to the company that the refusal stems from the design of Moderna’s study of its messenger ribonucleic acid (mRNA) flu shot.

“Your control arm does not reflect the best-available standard of care in the United States at the time of the study,” Prasad wrote. “I note that this determination is consistent with FDA’s advice given to you prior to your study.”

Moderna tested the experimental vaccine, called mRNA-1010, against a different flu vaccine in a clinical trial.

“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Moderna CEO Stéphane Bancel said in a statement.

The FDA did not identify any specific safety or efficacy concerns with the vaccine, Moderna said.

Andrew Nixon, a spokesman for the Department of Health and Human Services, the FDA’s parent agency, said that the trial used the wrong comparison vaccine.

“Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists,” Nixon told The Epoch Times in an email.

The move comes after Health Secretary Robert F. Kennedy Jr. announced in 2025 that some contracts for mRNA development would be canceled because of concerns over the effectiveness of those vaccines against upper respiratory infections such as COVID-19 and flu.

“We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate,” Kennedy said at the time.

The Pfizer-BioNTech and Moderna COVID-19 vaccines utilize mRNA technology. The FDA in 2025 narrowed the approval for those shots.

Moderna in 2024 submitted its phase three study to the FDA review. The agency sent written guidance back, which did not raise any objections about the phase three trial, Moderna said.

Following the completion of the experimental shot’s phase three efficacy trial in August 2025, Moderna held another meeting with the FDA agency for feedback. Moderna said that at no time during the meeting or in written feedback did CBER hint that it would refuse to review the shot’s application.

“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Bancel said.

The same vaccine has been accepted for review in the European Union, Canada, and Australia.

Moderna said it has requested a meeting with the FDA to understand the path forward.

The pharmaceutical company said it does not expect impacts to its 2026 financial guidance and forecasts the earliest approvals for its experimental flu shot to begin late 2026 or early 2027.

 Zachary Stieber contributed to this article.