Reuters published an update on Pfizer’s Lyme vaccine trials (10.11.2023), “FDA finds no misconduct at trial sites for Pfizer’s Lyme disease shot, Care Access says.” According to the article, the third party contract research firm, Care Access, has said that the FDA regulator did not find any misconduct at clinical sites managed by Care Access for Pfizer/Valneva’s trial of a Lyme disease vaccine candidate.
This Lyme Disease Association website Vaccine page begins with a series of current articles on Lyme disease vaccine efforts and pertinent vaccine peer review articles. Scrolling down, the pages continue to go backward in time to the history of early Lyme disease vaccines and the controversy which surrounded the vaccine trials and the subsequent LymeRix FDA approval, and then the withdrawal from the market of that vaccine.
Valneva SE and Pfizer Inc. announced in a press release, data showing positive pediatric and adolescent immunogenicity and safety for, VLA15, their Lyme disease vaccine candidate, when administered as a booster. These results, taken from the Phase 2 study one month after the booster dose, showed a notable anamnestic antibody response in pediatric and adolescent participants as well as in adults.
EXPECTATIONS: The recent Bloomberg article on the upcoming Lyme disease vaccine was not a surprise but was certainly a disappointment to the Lyme community and the Lyme Disease Association Inc. (LDA). The reporter spent time tracking me down to do an interview, as she indicated to me, many in the Lyme Community had suggested to her that I should be interviewed, probably due to the LDA’s involvement in the Lyme scene during the prior vaccine withdrawal.
LDA INVOLVEMENT IN EARLY VACCINE: At the time the first Lyme OspA vaccine, LymeRix®, was receiving FDA approval, with the most provisos− according to the chairperson−the LDA was already more than a decade into educating about and providing research funds for Lyme disease. As LDA president, I was educating in NJ and elsewhere. The prevailing questions and comments were always the same: talk and questions about the vaccine− problems that many people said they/acquaintances were experiencing and attributing to the vaccine.
Bloomberg released an article “Lyme Disease Has Exploded, and a New Vaccine Is (Almost) Here” on 8.24.2023, written by Kristen V Brown and Nacha Cattan. The article talks about Lyme disease and a potential new vaccine. In recent times, Lyme disease has become the most common vector-borne illness in the US. Due to this increasing prevalence of this disease, there is more urgency to develop a vaccine. Currently, there is only a vaccine available for dogs against Lyme disease.
In a breaking Fierce Biotech news article, 08.22.2023, Pfizer announced that the number of people enrolled in the phase 3 clinical trial for the Lyme vaccine (VLA15) will be significantly […]
The Molecular Therapy Journal (Pine M., et al.) 08.01.2023, published “Development of an mRNA-lipid nanoparticle vaccine against Lyme disease.” In this study, scientists propose using a new method called “mRNA-LNP” to create a Lyme disease vaccine, similar to the successful COVID-19 vaccines. The vaccine would target a specific protein in the bacteria Borrelia burgdorferi that causes Lyme disease, called OspA. This protein is found on the surface of B. burgdorferi and is essential for its survival in ticks. By targeting this bacterium, the vaccine aims to prevent the bacteria from infecting humans when bitten by ticks.
In 1998, there was an alum-adjuvanted recombinant OspA protein vaccine release called LYMErix™, that showed to decrease Lyme disease by 75% within a year, but the vaccine was removed from the market in 2002, just four years after its release. Since then, there has been no FDA-approved vaccine for Lyme disease, while cases continue to rise.
Medical Xpress released an article “A vaccine that reduces ability of ticks to transmit Lyme disease bacteria” on 8.2.2023, written by Bob Yirka and Medical Xpress. The article focuses on a team of medical students and colleagues who have developed a type of vaccine to try and reduce the ability of ticks transmitting the bacteria that cause Lyme disease. This vaccine would be given to a host animal to prevent ticks from spreading the disease.
The Nantucker CURRENT (Graziadei, J.) 2.18.23, reported that Pfizer has shut down its Lyme disease vaccine trial site in Nantucket. Pfizer informed all Lyme disease vaccine clinical trial participants that the site was shut down “following potential violations of Good Clinical Practice (GCP) at clinical trial sites operated by a third party.”
ContagionLive published the article “Lyme Disease Vaccine Shows Antibodies 6 Months after Completion” by Senior Editor, John Parkinson, on December 1, 2022. The article provides details of the most recent investigational outcomes for Pfizer and Valneva’s Lyme disease vaccine candidate, VLA15.