The company that was running a Lyme vaccine trial on Martha’s Vineyard before it was discontinued earlier this year for alleged clinical standards violations says it has been cleared of misconduct by the U.S. Food and Drug Administration.
Care Access was running the trial sites on the Vineyard, Nantucket and several other U.S. locations as pharmaceutical giant Pfizer and French company Valneva work to find a cure for the disease. In February, Pfizer shut down the Vineyard trial, among several others, due to concerns about Care Access’ work.
Earlier this month, Care Access said the FDA inspected the company’s activities in the Lyme vaccine trials and it resulted in no “Form 483,” observations, meaning investigators found no clinical practices violations.
The FDA issues Form 483 citations when investigators determine conditions or practices may be in violation of FDA’s requirements. Care Access said the FDA conducted an in-depth, weeklong investigation in early October.
“We couldn’t be prouder of our team,” Care Access CEO Ahmad Namvargolian said in a 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.”
The FDA declined to comment on the issue, saying the agency does not discuss possible or ongoing clinical trials or compliance matters, except with the company involved.
In a statement to the Gazette, Pfizer stood by its decision to discontinue the trials for patients at the Vineyard and other sites. About 3,000 patients in all were affected.
“In February 2023, Pfizer completed a thorough review of the operations and data collection at 19 sites in the Northeast run by the third-party clinical trial operators, and our investigation confirmed significant violations of Good Clinical Practice,” Pfizer said in a statement this month.
Pfizer has not fully elaborated on the violations, but noted that the ending of local trials was not due to safety concerns with the vaccine. Trials are still ongoing at sites that were not run by Care Access.
“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,” the company said.
The clinical trials were being done in 50 Lyme-endemic communities. The Vineyard was chosen because it has rates of Lyme disease nearly 10 times as high as the rest of Massachusetts.
