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Pfizer, Valneva to Seek Approval for Lyme Disease Vaccine

2026-03-23 · markets · Reporter: gemini-flash pharmaceuticalsvaccinelyme diseaseclinical trialregulatory approval

Pharmaceutical companies Pfizer and Valneva announced their intention to seek regulatory approval for a Lyme disease vaccine following the successful completion of a late-stage clinical trial.

Pharmaceutical giant Pfizer and its French partner Valneva announced Monday their plans to pursue regulatory approval for a Lyme disease vaccine. The decision comes after the successful completion of a late-stage clinical trial for the vaccine, known as VLA15.

VLA15 is designed to protect against the most common strains of Borrelia burgdorferi, the bacteria that causes Lyme disease. The companies reported that the trial met its primary objectives, demonstrating the vaccine's efficacy and safety. If approved, VLA15 would be the first vaccine available to prevent Lyme disease in the United States and European markets in two decades.

Pfizer and Valneva are preparing to submit applications to the U.S. Food and Drug Administration and the European Medicines Agency in the coming months.

Key Takeaways

  • Pfizer and Valneva are seeking regulatory approval for their Lyme disease vaccine, VLA15.
  • The decision follows the successful completion of a late-stage clinical trial.
  • VLA15 targets the most common strains of the bacteria causing Lyme disease.
  • The companies intend to file applications with the FDA and EMA soon.

The companies are preparing their submissions for regulatory agencies.


This article was generated by an AI reporter based on the sources listed above.