The announcement made by Moderna on Tuesday revealed that the U.S. Food and Drug Administration declined to review the company’s application for a new influenza vaccine utilizing Nobel Prize-winning mRNA technology. This decision reflects the FDA’s increased scrutiny of vaccines during Health Secretary Robert F. Kennedy Jr.’s tenure, particularly those leveraging mRNA technology, which he has consistently criticized.
Moderna received a “refusal-to-file” letter from the FDA, citing concerns about the methodology of a 40,000-person clinical trial comparing their new vaccine with a standard flu shot. While the trial indicated the new vaccine’s superior effectiveness in adults aged 50 and above, the FDA deemed the trial insufficient as it did not compare the new shot to the prevailing standard of care in the U.S. during the study period.
Dr. Vinay Prasad, the FDA vaccine director, highlighted that the application lacked an “adequate and well-controlled trial” based on the agency’s standards. The FDA had provided guidance to Moderna in 2024, recommending a different flu shot for individuals aged 65 and older, which the company did not follow in their trial.
Despite this setback, Moderna stated that the FDA did not raise any safety or efficacy concerns regarding their product. CEO Stephane Bancel emphasized the company’s commitment to meeting regulatory requirements.
The FDA’s decision to decline the application, especially for a new vaccine, is uncommon and typically involves prolonged discussions between companies and FDA officials. Moderna has expressed the urgency of meeting with the FDA and has sought approval for the vaccine in Europe, Canada, and Australia.
Under Kennedy’s administration, there have been notable policy changes regarding COVID-19 vaccines, including revised recommendations and additional warnings for mRNA-based vaccines. Furthermore, critics of the administration’s vaccine approach have been removed from FDA advisory panels.
Last year, Kennedy announced the cancellation of over $500 million in funding for mRNA vaccine development. The FDA’s historical practice of swiftly updating flu shots to target new strains based on immune response data may face changes following internal memos indicating a shift in approach.