Moderna says FDA is refusing to review flu shot application
A researcher works in the laboratory at Moderna Inc. headquarters in Cambridge, Massachusetts, USA, on Tuesday, March 26, 2024.
Adam Glanzman | Bloomberg | Getty Images
The Food and Drug Administration has refused to initiate a review ModernThe company announced Tuesday that Trump had applied for its experimental flu shot, another sign of the Trump administration’s influence in tightening vaccination regulations in the United States
Shares of the company fell about 7% in after-hours trading on Tuesday.
Moderna said the move contradicted previous feedback from the agency before it submitted its application and began Phase 3 trials of the vaccine, called mRNA-1010. The drugmaker said it had requested a meeting with the FDA to “understand the path forward.”
Moderna noted that the agency did not find any specific safety or effectiveness problems with the vaccine, but instead objected to the study design even though it had previously approved it. The company added that the move will have no impact on its 2026 financial guidance.
Moderna’s vaccine showed positive Phase 3 data last year and met all study objectives. At the time, Moderna said the standalone flu shot was key to its efforts to advance a combination vaccine against flu and Covid-19.
The announcement follows sweeping changes to U.S. vaccination policy last year under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.
Moderna on Tuesday made particular reference to the FDA’s top vaccine regulator, Vinay Prasad, who returned to the agency in August after being ousted. Prasad, who heads the agency’s Center for Biologics Evaluation and Research (CBER), has been vocal about tightening vaccine regulations and recently linked child deaths to Covid vaccinations.
In a letter signed by Prasad on February 3, he said the only reason the FDA refused to review the application was because of the way the clinical trial of the vaccine was designed.
The agency specifically questioned Moderna’s decision to compare its product to a standard, approved flu shot, arguing that it “does not reflect the best standard of care available.” As a result, the FDA said the study did not meet its definition of an “adequate and well-controlled” study.
Moderna disputes this argument, pointing out that FDA rules and guidelines do not actually require that the most advanced or high-dose vaccine be used as a comparator in clinical trials.
“This decision by CBER, which did not identify any safety or effectiveness concerns with our product, does not advance our shared goal of strengthening America’s leadership in the development of innovative medicines,” Moderna CEO Stéphane Bancel said in a press release. “It should not be controversial to conduct a comprehensive review of an influenza vaccine application that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed upon with CBER prior to initiation.”
Moderna expects the earliest approval of its flu shot will be 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.
