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

Pfizer and Valneva plan regulatory submission after a Phase 3 trial showed over 70% efficacy despite missing the initial primary statistical goal, addressing a major unmet health need.

  • 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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The HillThe Hill
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Lyme disease vaccine 70 percent effective: Pfizer

Pfizer and Valneva's Lyme disease vaccine shows 70% effectiveness in phase 3 trial. If approved, it would be the first human vaccine for Lyme disease.

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