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Pfizer and Valneva Seek Approval for Lyme Vaccine After Phase 3 Trial

Pfizer and Valneva will seek U.S. approval for a Lyme vaccine showing over 70% efficacy in a late-stage trial despite missing initial statistical goals.

  • Pfizer and Valneva announced that their Lyme disease vaccine candidate demonstrated strong efficacy of over 70% in the Phase 3 VALOR trial, though the primary endpoint was not met.
  • Despite missing the statistical goal in the trial due to fewer Lyme disease cases than anticipated, Pfizer expressed confidence in the vaccine's potential and plans to seek regulatory approval.
  • Lyme disease, caused by bacteria commonly spread by ticks, affects around half a million Americans annually, but there is currently no approved human vaccine available.
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A Pfizer and Valveva pharmaceutical laboratory vaccine against Lyme disease demonstrated "high efficacy" in a clinical trial, without meeting its primary criterion.

Pfizer plans to seek marketing approval for its new Lyme disease vaccine, even though the company's latest clinical trial fell short of its goal. However, the data collected shows that the vaccine reduced infection by more than 70 percent, which is why scientists and drugmakers believe the protection achieved is clinically meaningful.

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Business Wire broke the news in Crystal River, United States on Sunday, March 22, 2026.
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