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Aug 6, 2026

FDA approves Moderna's mFlusiva, first mRNA-based flu vaccine in the United States

The Food and Drug Administration approved Moderna's mFlusiva on Wednesday, marking the first mRNA-based influenza vaccine authorized in the U.S. The vaccine is approved for adults aged 50 and older, representing a significant expansion of mRNA technology beyond COVID-19 vaccines.

Aug 6, 2026·6 sources
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Top claims

  • ▪Moderna agreed to run a postmarketing clinical trial in adults ages 65 and older to confirm mFlusiva's clinical benefit as a condition of its accelerated approval
  • ▪Moderna's mRNA-based flu vaccine requires two to three months from strain selection to rollout, compared to approximately six months for traditional egg-based vaccines
  • ▪In a smaller study of adults aged 65 and older, mFlusiva generated a strong protective immune response compared to an existing high-dose flu vaccine

Subtopics

Drug Approval and Clinical Trials1FDA drug approval1MRNA vaccine technology1Public healthcare1Vaccine development and innovation1

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