A researcher works in the laboratory at Moderna Inc. headquarters in Cambridge, Massachusetts, U.S., Tuesday, March 26, 2024.
Adam Glanzman | Bloomberg | fake images
The Food and Drug Administration has refused to initiate a review of modernfiling for its experimental flu vaccine, the company announced Tuesday, in another sign of the Trump administration's influence in tightening U.S. vaccine regulations.
The company's shares fell about 7% in after-hours trading on Tuesday.
Moderna said the move is inconsistent with the agency's previous comments before it submitted the application and began phase three trials of the vaccine, called mRNA-1010. The drugmaker said it requested a meeting with the FDA to “understand the path forward.”
Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but rather objected to the study design, despite having previously approved it. The company added that the move will not affect its 2026 financial guidance.
Moderna's jab showed positive phase three data last year, meeting all trial objectives. At the time, Moderna said the standalone flu vaccine was key to its efforts to advance a combination vaccine targeting both flu and Covid-19.
The announcement follows sweeping changes to U.S. immunization policy over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.
On Tuesday, Moderna specifically pointed 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 regulations for vaccines and recently linked infant deaths to Covid shots.
In a letter signed by Prasad on February 3, he said the only reason the FDA declined to review the application was because of how the clinical trial of the shot was designed.
The agency specifically took issue with Moderna's decision to compare its product to an approved standard flu vaccine, 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” trial.
Moderna disputes that reasoning, noting that FDA rules and guidelines don't actually require trials to use the more advanced or higher-dose vaccine as a comparator in clinical studies.
“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not advance our shared goal of enhancing America's leadership in the development of innovative medicines,” Moderna CEO Stéphane Bancel said in a statement. “It should not be controversial to conduct a comprehensive review of a flu vaccine presentation that uses 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 of its flu vaccine to be in late 2026 or late 2027, pending regulatory reviews in the US, Europe, Canada and Australia.
The FDA said it does not comment on regulatory communications to individual sponsors.
