FDA Refuses to Review Moderna’s Influenza Vaccine Application

The Food and Drug Administration (FDA) has declined to review Moderna’s application for its new influenza vaccine, a decision announced by the company on Tuesday. This unexpected refusal raises questions about the FDA’s current stance regarding pharmaceutical companies and may reflect broader implications of the Trump administration’s policies on vaccine development.

Moderna’s response included the release of a letter from Vinay Prasad, head of the FDA’s biologics division, along with a pointed statement from CEO Stephane Bancel. Bancel criticized the decision, asserting that it undermines the collaborative goal of enhancing America’s leadership in innovative medicine development. Central to the controversy is the FDA’s requirement for a control vaccine in the efficacy trials, specifically what existing influenza vaccine should have been utilized, given that Moderna’s new shot employs the same mRNA technology as its Covid-19 vaccine.