After Shutdown Of Lyme Disease Vaccine Trial, FDA Reportedly Finds No Misconduct
Jason Graziadei •
Nearly eight months after Pfizer abruptly pulled the plug on its Lyme disease vaccine trial site on Nantucket, the FDA has reportedly found no misconduct on the part of the company that was operating the clinical trial.
Back in February, the pharmaceutical giant informed all Nantucket participants in the vaccine clinical trial, which had been underway since last fall, that the island’s trial site was being shut down “following potential violations of Good Clinical Practice (GCP) at clinical trial sites operated by a third party.”
That third party was the Boston-based Care Access research organization, which immediately denied the allegations.
The GCP standards “are designed to put participants’ interests first and ensure high scientific integrity.” At the time, Pfizer did not specify what the potential violations involved.
But on Wednesday, Care Access stated that a recently completed FDA inspection found no GCP violations by the company. In a press release, Care Access stated that the FDA inspection lasted from October 2nd to October 10th, 2023, and was an in-depth review of the company's contributions to the trial, including the general GCP requirements, patient safety, and data integrity.
“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," said Care Access CEO Ahmad Namvargolian. "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 February, Pfizer said it was discontinuing half of the study’s participants due to the alleged GCP issues, but stated the shutdown was not due to safety concerns with the vaccine.
The vaccine - manufactured by Pfizer and its partner Valneva - is now in the third and final phase of a clinical trial. With Nantucket's incidence rate of tick-borne diseases among the highest in the nation, the island was selected as one of the sites for the clinical trial of the vaccine, along with Martha's Vineyard, Block Island, Maine, and other "Lyme disease-endemic" areas in the U.S. and Europe.
Several hundred Nantucket residents went through the pre-screening process to enroll in the clinical trial, but it's unclear how many people on the island were actively enrolled in the trial when it was shut down. Care Access' vaccine clinic on Nantucket included two mobile trailers and three service vehicles at the VFW, along with a number of rented tents, and as many as 10 staff members who are commuting from Cape Cod.