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Tuesday, June 16, 2026

FDA briefing docs signal likely approval of Moderna's mRNA flu shot

 


  • FDA posted briefing materials ahead of June 18 VRBPAC meeting on mFlusiva (mRNA-1010) flu vaccine
  • Documents noted immune response data may support effectiveness in adults 65+ and superior efficacy vs standard shots in 50-64 group
  • Viewed as surprisingly positive given prior regulatory scrutiny of mRNA flu application
  • Moderna also announced same-day organizational changes expanding leadership for 2027-2028 launches including flu and oncology products
  • Stock surged ~10% to ~$57 intraday from $52.13 prior close on heavy volume
  • Moves tied directly to pipeline momentum in vaccines per IBD and press releases

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