Nantucket residents are among thousands of participants in Pfizer's clinical trial of a new Lyme disease vaccine who have been abruptly booted from the trial.
The pharmaceutical giant on Friday 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.”
The GCP standards “are designed to put participants’ interests first and ensure high scientific integrity.” Pfizer did not specify what the potential violations involved.
Beyond Nantucket, Pfizer said it was discontinuing half of the study’s participants due to these issues, but said the shut down was not due to safety concerns with the vaccine. The study remains ongoing at other sites, and Pfizer intends to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the vaccine in 2025 if the the Phase 3 clinical studies are successfully completed.
The Nantucket site was operated by the Boston-based Care Access research organization at the VFW. Several hundred island residents went through the pre-screening process to enroll in the clinical trial, but it's unclear how many people on Nantucket were actively enrolled in the trial.
In a statement posted to its web site, Care Access said: "Pfizer informed us of its decision to discontinue thousands of study participants only recently, and we disagree with the decision and its basis. We are sharing information with the FDA and the independent Institutional Review Board for this study to ensure they have the facts."
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.
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.
The e-mail Nantucket-based participants received from Pfizer reads as follows:"Dear Participant, Thank you for your participation in the Phase 3 Vaccine Against Lyme for Outdoor Recreationists (VALOR) study. We are writing to you to provide an important update about the study. Following potential violations of Good Clinical Practice (GCP) at clinical trial sites operated by a third party, Pfizer conducted a thorough review of the operations and data collection at these sites. GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. These standards are designed to put participants’ interests first and ensure high scientific integrity. The outcome of Pfizer’s assessment is that we will be discontinuing involvement of these study sites with the VALOR study. It is important to note that this decision was not due to any safety concerns with the study vaccine and was not prompted by a participant-reported adverse event. Unfortunately, your study site is one of the sites operated by this third party, and this means that your participation in the study will need to end early. You will not receive any further doses or provide additional blood samples. However, we do ask that you continue to follow up with safety reporting for a minimum of 6 months after your last dose. Please find below next steps: • A site staff member will be contacting you to schedule a final study visit. This visit will be conducted via a phone call. • It is important that you continue to report any changes in health or side effects. • At the end of study, we will let you know if you were in the placebo or active study vaccine group. • We are committed to staying in touch and sharing updates on the study’s progress. • If you have questions, you can contact a study representative at the following phone number 1 (267) 925-2700 or by email to firstname.lastname@example.org at your convenience. We understand that this update may be disappointing. Please know that despite your discontinuation in the study now, your participation will still help us to learn more about possible solutions to help prevent Lyme Disease. On behalf of the teams at Pfizer and Valneva, thank you again for volunteering for the VALOR study. Sincerely, Bill GruberSenior Vice President, Vaccines Research & DevelopmentPfizer, Inc."