A first of its kind Lyme disease vaccine trial ran into a road block last weekend as the developers announced they had discontinued the study for about half of the thousands of participants in the U.S. — including those on Martha’s Vineyard.
A first of its kind Lyme disease vaccine trial ran into a road block last weekend as the developers announced they had discontinued the study for about half of the thousands of participants in the U.S. — including those on Martha’s Vineyard.
The clinical trial, developed by pharmaceutical giant Pfizer in partnership with the French company Valneva, started last summer in 50 Lyme-endemic communities. The Vineyard, which has rates of Lyme disease nearly 10 times as high as the rest of the state, was selected as a trial site.
On the Vineyard, several hundred participants took part in the study, getting injections at clinic sites at the Martha’s Vineyard Regional High School and Vineyard Medical Care in Tisbury.
The discontinuation, according to Pfizer, was not due to any safety concerns with the vaccine and wasn’t prompted by a “participant-reported adverse event.”
Rather, the companies announced they had discontinued the study after they learned of violations in clinical practice standards by Care Access, a third-party company used to run some of the trial sites.
A Pfizer spokesperson on Tuesday would not confirm that the Vineyard trial was one of the sites that had been shut down, but Islanders involved with the study said that they had been notified this weekend about ending the trial.
“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,” an email to a participant read. “You will not receive any further doses or provide additional blood samples.”
Participants on the Vineyard and other canceled sites, including Nantucket, are asked to continue to report any changes in health or side effects. Trials at other sites will continue, and at the end of the study, all participants will be told if they were in the placebo group or not.
On an Island where Lyme disease has reached epidemic proportions, the cancellation was a huge disappointment.
“It’s a real shame,” said Dr. Michael Loberg, the president and CEO at Vineyard Medical Care. Dr. Loberg is also on the Tisbury board of health and has long been involved with tick-borne disease prevention on the Island. “The drug certainly appeared safe and had promising efficacy.”
Most people in the trial on the Island had received at least one or two injections. Officials at Care Access, the third-party company that was running the trials at several sites including the Vineyard, previously told the Gazette that there would be three shots altogether.
While Pfizer never pinpointed the alleged violation that halted the studies, the stoppage seems to be connected to data collection. In a statement, Pfizer said that integrity of data collected in clinical trials is “critical to provide evidence and confidence in a potential vaccine or medicine’s safety and efficacy.”
In its own statement, Care Access said it was committed to patient safety and data integrity and disagreed with Pfizer’s decision to pull the plug on thousands of study participants.
“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,” Care Access wrote.
Dr. Loberg said he believed there was an audit that found some sites were not collecting data with the precision or reliability deemed necessary. The net result was Pfizer cutting any sites using Care Access.
He was not aware of any flaws involved with the Vineyard trials.
“We and our patients here did nothing wrong,” Dr. Loberg said. “It’s a real shame for those in the trial. It’s just heartbreaking.”
But Dr. Loberg said it is good that Pfizer will let people know if they were part of the placebo group, potentially allowing them to be involved in further studies. Eventually, he hoped that trials could be rekindled on the Island, or that the vaccine could be proven safe and effective enough to go to market.
Comments
So Pfizer left the Martha's
ChrisSo Pfizer left the Martha's Vineyard study group hanging because a third party violated protocol? Then get another third party in as soon as possible to complete the study. That is terrible and an medical-ethical violation in my opinion.
Your issue should be with
John EdgartownYour issue should be with Care Access. They are the third party who was responsible for conducting and executing the trial. There are procedural protocols in place that are required to be met by the FDA and if those protocols are not followed it voids the data/research. Pfizer did the moral and ethical right thing by stopping the test once they became aware of the violations.
Once the study is ruined it’s ruined. You can’t simply bring in a new third party. All data is tainted and suspect. What would be unethical would be to ignore it and hide it. It’s critical to the safety of the participants and potential future users of the vaccine that all aspects of testing protocols are followed otherwise serious medical issues or even death could arise.
Read the comment below from one of the participants. Care Access should be ashamed. Very unprofessional and they ruined a study in an area where we needed the research most.
Pfizer needs to be
Dominique Oak BluffsPfizer needs to be investigated. I'm not the only one who thinks this, and I can not be the only person commenting on this post. The problem with the media, both small and large, is that they censoring the publics opinions and often side with a political party or even worst, take the side of a big company, causing big problems. censoring the voice of the public is a terrible thing to do.
The media needs to go back to being unbiased and report the actual news, not provide the public with an opinion. Report the truth, as the truth will set you free...and probably helps humanity more.
I was part of the study and
jon edgartownI was part of the study and had extremely unprofessional and unorganized appointments with the Care access team. Even their staff kept saying how unorganized the company was. I was sent to the wrong location, sat at appointments where they ran out of vaccine and thus had to come back for additional appointments, had appointments rescheduled at the last moment and was never provided the compensation they promised. It is really too bad as this is such an important trial, especially for those of us on the vineyard
I was part of the study and
Karen Vineyard havenI was part of the study and found the communication to be lacking. I could never get them to call me back, sat in an unheated trailer for 1.5 hours before they had my shot ready, and now I have received a piece of mail with my address and someone else’s name, and a different person notified me they received a piece of mail with my name and their address. I now have to question if any of the data reported by care access is accurate. When you can’t get the simple things right, what happens with the critical data. It is very disappointing as the people who have volunteered to risk their health to this study are now told the overseers were not paying attention.
I feel like ending a study
Wendy West TisI feel like ending a study before the vaccination schedule is complete would pose health risks to those who were participating in the study. I would assume that Pfizer had an ethical obligation to those who received the actual vaccine to complete their dosages. I can only imagine not completing the necessary amount of shots to complete a dosage isn akin to not finishing all of your antibiotics….
Both my husband and I were in
Karen OrleansBoth my husband and I were in the trial and are extremely disappointed. We did find the experience to be disorganized and were told that the intake process involved training new people so we were patient but it took longer than expected and it was not like any other lab experience. We were assigned the facility in Wareham and once we learned of the closure we even suggested we would drive another 90 miles to a Pfizer approved location. No response to that inquiry.
I am sorry to hear about
Jeff Winter Kissimmee, FLI am sorry to hear about Pfizer ending it’s Lime disease study on the Vineyard. Pfizer has not only botched this important study but also produced failed Covid-19 vaccines that didn’t stop the transmission of the virus. It’s time we discontinue putting our trust in this shady pharmaceutical company.
Silly comments. I had all 3
David EdgartownSilly comments. I had all 3 Pfizer Covid shots/boosters. When I came down with a (mild) case of Covid my doctor said if I'd been unvaccinated I'd likely have been in the ICU, or worse, given my health conditions. I'm actually grateful to Pfizer for getting me through Covid. BTW Pfizer is continuing the Lyme trials in other regions where Care Access was not used and did not taint the study. I think Pfizer did the right thing by terminating its arrangement with a sloppy vendor.
Vaccine effectiveness is not
John P West TisburyVaccine effectiveness is not measured by post-immunization viral transmission. The effectiveness of the mRNA COVID vaccines in preventing serious illness and death is quite well documented. And Pfizer didn't botch the study, the agency Care Access charged with study administration locally apparently did not maintain proper data integrity standards. You would not want study results based on bad data, so Pfizer appropriately has decided not to include this local data in its study. That's good practice, most unfortunate for the folks who participated, but the blame lies on Care Access, not Pfizer. I have no affiliation with either, but respect good science.
Why is this being called the
Ron EdgartrownWhy is this being called the first study of its kind? There was a similar study of a lime vaccine done on the Vineyard (among other places) back in the 1990's. I believe the vaccine was being tested by Glaxo Smith Kline if I recall correctly. My wife was one of the nurses involved in conducting the study and administering the lime vaccine. I don't think the vaccine ever made it to market but it was a lime vaccine trial that predates this one by 25 years or so.
You’re absolutely correct.
Quitsa ChilmarkYou’re absolutely correct. My wife actually received the old vaccine before it was taken off the market because the manufacturer did not think it was profitable. We used to joke that our dog could get Lyme vaccine but we couldn’t.
I was one of the subjects in
Quitsa ChilmarkI was one of the subjects in the trial and had two injections. This news is extremely disappointing although not entirely a surprise. ICare Access was very poorly organized and I had to correct various errors they made in recording information during my intake interview and subsequent visits. It seemed there was usually only one person in their group that actually knew what they were doing. The others seemed pretty thoroughly clueless and in need of more training and experience.
I donblame Pfizer except perhaps for choosing such a poor contractor. Let’s hope this doesn’t slow down the approval process if the vaccine ultimately proves effective.
Glaxo's vaccine was pulled
Monroe VHGlaxo's vaccine was pulled from the market - people had complained of side effects (although FDA said not due to vaccine).
I can't imagine the time that was wasted by folks here participating in this trial. And now we'll need to wait until (and if) the vaccine is approved by the FDA to get vaccinated. Some of these 3rd-party administrators stayed at my home to cut down on commuting tome from the mainland. I am not entirely surprised that strict procedures weren't followed, based on my experiences with workers associated with this third party.
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