Pfizer, Valneva Discontinue Certain Trial Sites For Phase 3 Study Of Lyme Disease Vaccine Candidate

  • Pfizer Inc PFE and Valneva SE VALN announce that Pfizer, as the study sponsor, will discontinue a significant percentage of participants in the U.S. who had been enrolled in the VALOR Phase 3 study of a Lyme disease vaccine candidate, VLA15. 
  • These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. 
  • The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event.
  • Once Pfizer learned of potential violations of GCP, it thoroughly reviewed the operations and data collection at the clinical trial sites run by the third party. It followed standard operating safeguards to determine the correct course of action.
  • The trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. 
  • The companies intend to work with regulatory authorities. As previously announced, Pfizer aims to potentially submit marketing applications to the FDA and the European Medicines Agency in 2025.
  • Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.
  • It is considered the most common vector-borne illness in the Northern Hemisphere.
  • Price Action: VALN shares closed at $13.66, and PFE shares closed at $42.92 on Thursday.
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