FDA Refusal to File Moderna Flu Vaccine Signals Chilled Innovation in Vaccines

Moderna’s mRNA influenza vaccine was not even considered by the FDA after a “refuse to file” ruling, despite earlier signals that its trial design was acceptable. The decision is described as coming from Vinay Prasad, an FDA appointee aligned with RFK Jr., who overruled career staff, signaling a broader shift under Kennedy’s leadership away from standard scientific processes. The piece warns this regulatory pivot could deter vaccine investment, undermine pandemic preparedness, and slow the development of future mRNA vaccines.