FDA Rejects Moderna’s Application for New mRNA Flu Vaccine

The Food and Drug Administration (FDA) has decided not to proceed with Moderna’s application for a new mRNA flu vaccine. This announcement, made by Moderna on a Tuesday, highlights the FDA’s ongoing scrutiny of vaccines, particularly those developed using mRNA technology.

FDA’s Rejection of Moderna’s mRNA Flu Vaccine

Moderna received a “refusal-to-file” letter from the FDA, which questioned the methodology of its clinical trial. This trial, involving 40,000 participants, aimed to compare Moderna’s new vaccine to a standard flu shot. The results indicated that the new vaccine was somewhat more effective in adults aged 50 and older.

Key Points from the FDA’s Letter

• The FDA deemed the trial inadequate as it did not compare the new vaccine to “the best-available standard of care” at the time.
• Dr. Vinay Prasad, director of the FDA’s vaccine division, mentioned that earlier guidance provided by the FDA was not followed.
• Despite these concerns, the FDA initially permitted the study to continue as planned.

Moderna claimed that it had shared additional data from a separate trial comparing its new vaccine to a licensed high-dose flu vaccine intended for seniors. The FDA reportedly raised no safety or efficacy concerns about the product.

Implications of the FDA’s Decision

Moderna’s CEO, Stephane Bancel, expressed disappointment, stating that the decision undermines efforts to enhance innovation in medicine. The company has requested an urgent meeting with the FDA and has also applied for approval of its vaccine in other countries including Europe, Canada, and Australia.

Under Health and Human Services Secretary Robert F. Kennedy Jr., the FDA has altered its approach to vaccines. These changes include rolling back recommendations for COVID-19 vaccines and issuing new warnings concerning mRNA technology.

Expert Opinions on Vaccine Development

• Critics, including former Surgeon General Jerome Adams, have condemned the FDA’s decision to limit mRNA research, warning it could lead to loss of lives.
• Longstanding practices by the FDA allowed quick updates to flu vaccines, which are now at risk due to the agency’s recent changes.

Democratic Senator Patty Murray from Washington criticized the FDA, arguing that its decision lacks scientific rationale and that vaccine policy has become overly influenced by conspiracy theories.