Pfizer’s Lyme disease vaccine study cut due to protocol violations

pharmafile | February 20, 2023 | News story | Medical Communications  

Valneva and Pfizer have seen their Lyme disease vaccine study cut down after some clinical trial sites were revealed to be not adhering to Good Clinical Practice (GCP) standards. Almost half of the trial’s participants will be withdrawn following these GCP violations.

The protocol violations took place in trial sites run by third-party trial operator, Care Access, meaning that approximately half the patients in the VALOR study will be withdrawn from testing.

Pfizer and Valneva are eager to confirm that there have been no safety concerns with the VLA15, Lyme disease vaccine. The companies are now focusing on getting the trial back on track at sites not being organised by Care Access.

The details of these violations have not yet been shared, however GCP covers a wide range of standards for design, conduct, monitoring, auditing, recording, analysis and reporting of clinical trials, with the key principle being that trials are safe, ethical and scientifically sound.

Pfizer has stated that it will enrol new patients for the trial at the other trial sites, and aims to work with regulatory authorities as previously planned, hoping to submit a Biologics Submission Application (BLA) to the FDA and a Marketing Authorisation Application (MAA) to the EMA in 2025.

Kit Longley, a spokesperson for Pfizer, explained that “the violations were related to study conduct” and that the discontinuation of the participants was “not due to any safety concerns” with the vaccine candidate.

 

Betsy Goodfellow


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