Last week we published a post about Pfizer's withdrawal of multiple trial sites and potentially thousands of participants in their Lyme "vaccine" phase III trial.
Additional information is trickling in, including a statement by the CEO of the affected contractor:
We jointly embarked with Pfizer on the VALOR study to deliver this highly unique and complex research study. We worked closely with Pfizer every step of the way, from design to execution, in order to reach participants in remote and sometimes inaccessible communities where Lyme Disease is endemic.
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.
Our commitment is to patient safety and data integrity, and we are dedicated to providing research excellence across our research sites around the globe on hundreds of active studies that serve 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. We are committed to continue serving these communities to fight Lyme Disease and other health conditions.
This statement seems to imply that Pfizer has thrown CareAccess under the bus for undisclosed violations of Good Clinical Practice (GCP). TruthCures certainly will be following up with FOIA requests and other communications to ascertain the real issues underlying this serious development. Knowing the impossibility of developing a Lyme vaccine, as well as the inability to prove it works due to the lack of a valid diagnostic, we are highly doubtful that this is a simple issue of GCP violation.
Initial news reports downplayed the significance of shuttering trial sites affecting half of U.S. participants. But an article in Fierce Biotech doesn't mince words:
Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong.
Additionally, the Nantucket Current published the headline, "Pfizer Abruptly Shuts Down Nantucket Lyme Disease Vaccine Trial Site", indicating that there may be more to this than meets the eye.
Here's what Pfizer told the participants who got dumped:
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 email@example.com 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.
Senior Vice President, Vaccines Research & Development
You can watch for updates to the clinical trial locations, protocols, etc. at the VLA15 page on clinical trials dot gov.
We encourage any discontinued participants to contact us at firstname.lastname@example.org as we are currently working on multiple fronts to prevent VLA15 from getting to market and would be interested in hearing about your experience.