FDA Rejects Moderna’s mRNA Flu Vaccine Application

The FDA has refused to consider Moderna’s application for a new mRNA flu vaccine, citing concerns about the study’s comparator arm, which they deemed inadequate. CEO Stéphane Bancel emphasized that the decision raised no safety or efficacy issues and contradicted prior FDA guidance. This refusal comes amid heightened scrutiny of vaccine approvals under Health Secretary Robert F. Kennedy Jr., who has implemented policy shifts and criticized mRNA vaccines. Moderna plans to engage with the FDA to clarify the decision while regulatory reviews continue in other countries.

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