No Care Access Issues in VALOR Trial: Company

A 10/2-10/10 FDA for-cause good clinical practice (GCP) inspection of Care Access’ activities in the Pfizer VALOR trial of an investigational Lyme disease vaccine resulted in no inspection observations and no issuance of a form FDA-483, according to a company statement. The inspection came after Pfizer discontinued over 3,000 trial participants at Care Access clinical sites due to alleged GCP violations.

“The lack of any findings by the FDA investigator is wholly consistent with Care Access’ assertions that there were no GCP violations,” the company says.

When Pfizer dropped the trial participants, the company said it was due to violations of GCP requirements at certain sites run by a third-party clinical trial site operator. “The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event,” Pfizer said.

The trial is continuing at other unaffected sites, the company says.