STAT+: CRO claims there was no misconduct in Lyme vaccine trial it ran for Pfizer
A company that Pfizer blamed for problems with a clinical trial testing a Lyme vaccine claims regulators gave its procedures a clean bill of health during a recent inspection.
A company that Pfizer blamed for problems with a clinical trial testing a Lyme vaccine claims that regulators gave its procedures a clean bill of health during a recent inspection.
Care Access served as a contract research organization and had enrolled about 3,000 patients in the late-stage trial. But the patients were dropped last February after Pfizer and its partner, Valneva, claimed that violations of Good Clinical Practice — the international ethical and quality standards used by all clinical researchers — had been found at the study locations.
Pfizer and Valneva maintained there were no safety issues or adverse events prompting the decision, and instead blamed unspecified problems with the conduct of the study. The decision meant that data from roughly half of the trial were scrapped, which delayed their plans to seek regulatory approval for the shot until 2026, instead of 2025. Care Access, meanwhile, laid off hundreds of employees.
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