Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator.
The companies disclosed Friday that violations of Good Clinical Practice, the international ethical and quality standards used by all clinical researchers, had been found at sites run by an undisclosed trial operator, leading Pfizer and Valneva to drop trial participants at those locations. The decision was not due to safety concerns or any participant-reported adverse events, but due to study conduct, a company spokesperson told STAT.
Pfizer announced a deal with Valneva in 2020 to co-develop and commercialize the vaccine. The companies had planned to enroll 18,000 people in the Phase 3 trial. Approximately 7,000 participants have been enrolled so far, Pfizer said, and the trial continues to enroll new participants. The company still plans to file for drug approval in the U.S. and Europe in 2025.
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