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FDA rejects Moderna's flu vaccine application over comparison concerns

Feb 11, 2026, 12:01 AM10
(Update: Feb 11, 2026, 12:01 AM)
American biotechnology company

FDA rejects Moderna's flu vaccine application over comparison concerns

  • The FDA rejected Moderna's application due to issues with the trial comparator.
  • Moderna argued that the stated concerns were inconsistent with previous FDA communications.
  • The FDA's rejection highlights ongoing tensions around vaccine approvals and mRNA technology.
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