FDA Finds No Misconduct by Care Access in Pfizer’s Lyme Vaccine Trial

BOSTON -- Businesswire -- Care Access announced today the completion of a for-cause Food and Drug Administration (“FDA”) Good Clinical Practices (“GCP”) inspection related to Care Access’s activities on the Pfizer VALOR trial. The inspection resulted in no FDA Form 483 observations, meaning the FDA investigator found no GCP violations by Care Access in the VALOR trial. The FDA inspection lasted from October 2nd to October 10th, 2023, and was an in-depth review of Care Access’s contributions to the trial, including with respect to general GCP requirements, patient safety, and data integrity.

Earlier this year, Pfizer discontinued over 3,000 participants (https://www.pfizer.com/news/announcements/pfizer-and-valneva-issue-update-phase-3-clinical-trial-evaluating-lyme-disease) at Care Access sites on the study due to alleged GCP violations. Care Access disagreed with Pfizer’s decision (https://careaccess.com/about/news/2023-02-17-statement-about-pfizers-decision-to-discontinue-valor-study-participants) and rejected the allegations. The lack of any findings by the FDA investigator is wholly consistent with Care Access’s assertions that there were no GCP violations.

“We couldn’t be prouder of our team,” said Care Access CEO Ahmad Namvargolian. “This confirms what we’ve known all along about Care Access’ outstanding systems and controls to ensure regulatory compliance and patient safety on all the studies it performs. We’re very glad to have had the opportunity finally to undergo this independent, searching review by an FDA expert, which confirmed what we’ve always said about our performance on the VALOR trial and beyond.”

The Pfizer VALOR study is ongoing and seeks to determine the safety and efficacy of a potential Vaccine for Lyme Disease. Care Access had deployed its unique decentralized model (https://careaccess.com/case-studies/bringing-a-lyme-disease-vaccine-trial-to-rural-areas-where-there-are-no-research-sites?play=5khfjcz0zu) to bring this study to previously unreachable communities that are most impacted by Lyme Disease. With a fleet of mobile research vehicles and a team of traveling research professionals, Care Access specializes in having clinical research meet the needs of a community, not the other way around.

About Care Access

Care Access is a global research company helping to accelerate the arrival of new medicines. With a global network of over 150 research sites, Care Access supports research studies conducted by 14 of the top 20 biopharmaceutical companies. In addition to its proven track record of globally top-enrolling sites, Care Access partners with new-to-research communities and establishes high-quality research site infrastructure locally to expand access to clinical trials and increase representation.

To learn more visit www.careaccess.com.

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