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FDA Rejects Moderna's Flu Vaccine Amid mRNA Controversy

2/15/2026

Summary

Story summary

The U.S. Food and Drug Administration (FDA) issued a Refusal to File for Moderna's mRNA-1010 influenza vaccine, citing a technicality in trial comparisons.
Moderna contends the FDA had previously approved their trial design.
Critics argue the decision reflects hostility toward mRNA technology under U.S. Secretary Robert F. Kennedy Jr., who has canceled multiple mRNA projects.
Regulators in Europe and Canada are reviewing Moderna's mRNA-1010.
The current flu season is severe.

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Story summary

The U.S. Food and Drug Administration (FDA) issued a Refusal to File for Moderna's mRNA-1010 influenza vaccine, citing a technicality in trial comparisons.
Moderna contends the FDA had previously approved their trial design.
Critics argue the decision reflects hostility toward mRNA technology under U.S. Secretary Robert F. Kennedy Jr., who has canceled multiple mRNA projects.
Regulators in Europe and Canada are reviewing Moderna's mRNA-1010.
The current flu season is severe.