Moderna says FDA refuses to review application for flu shot

Food and Drug Administration declines to launch investigation ModernaThe application for an experimental flu vaccine is another sign of the Trump administration’s influence, the company announced Tuesday. tightening vaccination regulations in the USA

The company’s shares fell nearly 7% in after-hours trading Tuesday.

Moderna said the move was inconsistent with the agency’s feedback before it submitted the application and started phase three trials on the vaccine, called mRNA-1010. The drugmaker said it requested a meeting with the FDA to “understand the path forward.”

Moderna said the agency did not identify any safety or effectiveness issues with the vaccine, but rather objected to the study design even though it had previously approved it. The company added that this move will not affect its 2026 financial guidance.

Moderna’s vaccine showed positive phase three data last year and met all trial goals. At the time, Moderna said its standalone flu vaccine was key to its efforts to develop a combination vaccine that targets both flu and Covid-19.

The announcement follows sweeping changes to U.S. vaccination policy last year under the administration of Health and Human Services Secretary Robert F. Kennedy Jr., a leading vaccine skeptic.

Moderna on Tuesday specifically highlighted Vinay Prasad, the FDA’s top vaccine regulator, who returned to the agency in August after being ousted. Prasad, who heads the agency’s Center for Biological Evaluation and Research (CBER), has been vocal about tightening regulations on vaccines and has recently linked child deaths to Covid vaccines.

Prasad said in a letter he signed on Feb. 3 that the only reason the FDA refused to review the application was because of how the clinical trial for the vaccine was designed.

The agency specifically objected to Moderna’s decision to compare its product to a standard, approved flu vaccine, arguing that it “does not reflect the best available standard of care.” As a result, the FDA said the study did not meet the definition of an “adequate and well-controlled” study.

Moderna disputes this logic, noting that FDA rules and guidelines do not actually require trials to use the most advanced or highest-dose vaccine as a comparator in clinical trials.

“CBER’s decision, which identifies no safety or efficacy concerns regarding our product, does not advance our shared goal of increasing America’s leadership in developing innovative medicines,” Moderna CEO Stéphane Bancel said in a statement. he said. “It should not be controversial to conduct a comprehensive review of an influenza vaccine rollout using an FDA-approved vaccine as a comparator in a study that was discussed and agreed upon with CBER before it began.”

Moderna said it expects the earliest approval for its flu vaccine to be in late 2026 or late 2027, pending regulatory reviews in the U.S., Europe, Canada and Australia.

The FDA said it does not comment on regulatory communications to individual sponsors.