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.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect