Eight months after pharmaceutical company Pfizer called for the abrupt discontinuation of Lyme disease vaccination trials at a number of locations — including the Vineyard and Nantucket — a federal investigation into the Island’s facilitator for the trial has found that Care Access was not in violation of any clinical practices.
Last year, Martha’s Vineyard joined dozens of Lyme-endemic communities chosen to participate in the third phase of testing a vaccine, VLA15, to combat Borrelia burgdorferi — the tick-borne bacteria that causes Lyme disease.
The Island’s sponsor for the study, Care Access, a third-party research organization that worked with Vineyard Medical Care to administer the vaccine, was only months into the trials when the drug’s developer reported that it would be shutting down 19 study sites due to good clinical practice (GCP) violations by third-party facilitators.
Now, according to Care Access, the Food and Drug Administration’s (FDA) investigation that followed Pfizer’s claims has “found no GCP violations by Care Access in the [vaccine] trial.”
“We couldn’t be prouder of our team,” Care Access CEO Ahmad Namvargolian said in a recent statement. “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.”
In a statement to The Times, Pfizer reps said that though the study’s discontinuation was not due to concerns of the safety of the vaccine or any reported adverse reactions to the drug, the company “stand[s] behind our decision to discontinue the recruited participants from the Phase 3 VALOR trial run by this third-party clinical trial operator, which was made according to our high-quality standards and in the best interest of the participants.”
“The Phase 3 VALOR study remains ongoing with other sites not operated by the third-party clinical trial operator, and Pfizer continues to enroll new participants,” Pfizer says. “To date, we have been encouraged by the data from the Phase 2 studies, which continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations.”
It remains unclear what prompted allegations of the GCP violations.
FDA representatives were not immediately available for comment.
