Less than six months after the first experimental Lyme disease vaccine was administered on-Island, pharmaceutical company Pfizer has announced the discontinuation of the clinical trials at a number of locations, including the Vineyard.
Last year, Martha’s Vineyard joined dozens of Lyme-endemic communities chosen to participate in the third phase of testing, with the goal of eventually introducing a standard vaccine to combat Borrelia burgdorferi, the tick-borne bacteria that causes Lyme disease.
The vaccine, VLA15, was developed through Pfizer’s collaboration with French vaccine company Valneva, and had long completed preliminary testing for safety and efficacy.
But last week, a statement released by Pfizer reported that nearly half of the study’s participants will be removed from the trials due to good clinical practice (GCP) violations by third-party facilitators.
“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,” a joint statement by Pfizer and Valneva reads.
Care Access, the third-party clinical research organization found to be in violation, was initially brought on by Pfizer, and served as the Island’s sole sponsor for the study. The organization, which helped Vineyard Medical Care administer the vaccine, released a statement following Pfizer’s decision to stop the trials on Feb. 17.
“We are most disappointed for the study participants and are heartbroken about the impact this will have on the underserved communities that we reached and with whom we partnered. We are committed to continue serving these communities to fight Lyme disease and other health conditions,” the statement read. “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.”
In an email to The Times on Tuesday, Care Access representatives wrote: “A lot of people worked very hard to bring an important potential Lyme disease vaccine to the islands but we are most sad for all of the incredible people who went out of their way to participate who are suddenly being discontinued from the study. As we say in the statement, we do not agree with the decision and its basis.”
Care Access declined to give further comment regarding the violation. The specifics remain unclear.
The discontinuation of the study is “a big disappointment,” Michael Loberg, president of Vineyard Medical Care and a member of the Tisbury board of health, told The Times Wednesday.
“From the perspective that really counts,” Loberg said, “that of the people who volunteered their time and their body to this particular endeavor, it’s a real shame.” He said the Vineyard was fortunate to be chosen to participate in the trials, considering the pervasiveness of Lyme disease. “This was one of the major unmet medical needs on the Island,” he said. “And here was the chance that a major pharmaceutical company had a drug that looked very good in preliminary testing.”
Loberg said many hundreds of participants enrolled in the study with Vineyard Medical Care, but unfortunately, “there is not a path forward for those people at the moment.”
However, the drug does have a path forward. Loberg said there are alternative clinical research organizations still collecting data, mainly in Europe, which could potentially lead the way to the vaccine being marketed after full approval.
The discontinuation of the program has nothing to do with the safety of the drug, Loberg reiterated. The vaccine is “shown to be a safe procedure.”
Although the vaccine has yet to meet the standards necessary to go on the market, the clinical trial will allow that to happen through continued enrollment of participants in other locations.
But for the Islanders who volunteered in order to rid the community of Lyme disease, Loberg said, “It’s a very sad thing. I feel bad for the people who enrolled in the trial in good faith.”
I was enrolled in the VLA15 trial via Care Access in Londonderry NH and describe my experience a bit at https://twitter.com/dhimmel/status/1618259842376019968, but will elaborate here.
In short, the Care Access staff were all nice and hard working people but the operation was a mess. My first visit took 5 hours, when it should have taken 1.5 hours. Most of the staff had just been replaced because the generators were improperly set up causing carbon monoxide poisoning. I experienced several clerical errors: my date of birth was entered incorrectly into the reimbursement system, and I have received mail for other study participants indicating that Care Access has mixed up addresses.
After the first visit, I was given a measuring tape to take home to measure any erythema migrans, but it was junk and off by several centimeters. Lot’s of waste produced by the trial and the mobile setup. Sad to see the project go down as a failure, but clinical research requires great diligence to produce meaningful readouts.
The sloppiness at the Care Access site I witnessed was severe. Hopefully, Care Access survives applies their talented workforce in a more organized and deliberate fashion.
Ah and one final thing that always got me, they would send out an appointment confirmation email whose template had a glaringly misplaced hyperlink. Was astonished that no one fixed the template over the couple months I was receiving these emails.
This is great news for the Care Access employees who sleep in cars in the parking lot…
I was a participant out of the Wareham location. I found Care Access to be unresponsive and poorly run. While the staff were nice they were unorganized and seemed to lack leadership. Hopefully they trials will be successful in the end.
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