Moderna announced the Food and Drug Administration has issued a Refusal-to-File letter for its mRNA-based influenza vaccine, stating the agency would not proceed with a formal review of the submission.
By yourNEWS Media Newsroom
Moderna said Tuesday that the U.S. Food and Drug Administration has declined to review the company’s application for its first mRNA-based influenza vaccine, marking a setback for the biotechnology firm as it seeks to expand its messenger RNA platform beyond COVID-19.
According to the company, the FDA issued a Refusal-to-File letter, indicating that the submission did not meet requirements for substantive review. Moderna said the agency’s top vaccine regulator, Vinay Prasad, wrote in a letter that the company’s clinical trial was not “adequate and well-controlled” and did not compare the experimental vaccine against what the regulator considers the best available product on the market.
In its large clinical trial, Moderna compared the investigational flu shot with Fluarix, an influenza vaccine produced by GSK and already approved for use.
Moderna said the decision was “inconsistent with previous written communications” it had received from the FDA’s Center for Biologics Evaluation and Research, known as CBER, which oversees vaccines and other biological products.
“The decision did not identify any safety or efficacy concerns with our product,” Moderna Chief Executive Officer Stéphane Bancel said in a statement. “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.”
Bancel added that the agency’s decision “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”
Moderna said it has requested a meeting with the FDA to discuss the agency’s position. The company also noted that its mRNA flu vaccine application has been accepted for review by regulators in the European Union, Canada and Australia.
The FDA’s decision comes amid broader discussions within the agency about vaccine approval standards. The current iteration of the FDA has called for reconsideration of certain vaccine approval procedures, including those related to influenza vaccines, under proposed federal policy changes during President Donald Trump’s administration. Those discussions have prompted reactions from public health and medical professionals.
Messenger RNA technology gained global prominence during the COVID-19 pandemic, when it was used to rapidly develop vaccines against the virus. Vaccines developed using mRNA platforms were credited by global health authorities with reducing severe disease and mortality during the pandemic.
During his first term, Trump described mRNA technology as a “modern-day miracle.” In his second term, he appointed Robert F. Kennedy Jr. as health secretary. Kennedy, who has expressed skepticism about vaccines, has overseen changes within federal health agencies, including reviews of vaccine-related policies.
The FDA has not publicly released detailed comments beyond the Refusal-to-File determination. Moderna said the agency’s letter did not cite specific safety or efficacy deficiencies in the submitted data.
The company’s request for further discussions with regulators signals that the review process for its influenza vaccine remains unresolved.
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