Pfizer and Valneva reported that their Lyme disease vaccine failed to meet its Phase III primary endpoint, blaming a low incidence of disease cases.
In the VALOR study (NCT05477524), which enrolled approximately 9,400 individuals over five years of age, the investigational six-valent OspA-based Lyme disease vaccine candidate PF-07307405 was 73.2% effective 28 days after the fourth dose compared to the placebo arm.
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The companies said that fewer than anticipated Lyme disease cases were accrued over the study period, meaning the primary endpoint was not statistically significant. Lyme disease is a bacterial infection, primarily caused by Borrelia burgdorferi, transmitted to humans through the bite of infected blacklegged ticks.
Despite this, the data was clinically meaningful, with the 95% confidence interval lower bound being above 20 in the second pre-specified analysis. As a result, Pfizer said it is confident in the vaccine’s potential and is continuing with planned submissions to regulatory authorities.
Dr Annaliesa Anderson, senior vice president and chief vaccines officer at Pfizer, said: “Lyme disease can cause potentially serious consequences – where individuals and families face symptoms that can disrupt daily life, work, and long-term health – and there is currently no vaccine available. The efficacy shown in the VALOR study of more than 70% is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating.”
“These results bring us a step closer to our goal of delivering a much-needed vaccine to help protect against Lyme disease. We are grateful to our partner Pfizer for their strong commitment, which we both share in developing this vaccine as quickly as possible”, added Thomas Lingelbach, CEO and board member of Valneva.
While the companies struck an upbeat tone on the data, investors were less convinced, with Valneva’s stock – listed on the ELA exchange – plunging 37.1%, from $4.56 at market close on 20 March to a low of $2.54 today (23 March) while Pfizer’s NYSE-listed stock appeared largely unaffected.
The vaccine has been developed as part of a collaboration between Pfizer and Valneva, following a license agreement in April 2020. This agreement also granted Pfizer exclusivity to manufacture and commercialise PF-07307405, assuming regulatory success.
Worldwide, there are currently no vaccines authorised to prevent Lyme disease following the 2002 withdrawal of GSK’s LYMErix from the US market, which was pulled due to fears of vaccine side effects, poor sales and class-action lawsuits.
There are other vaccine candidates in earlier stages, including two messenger RNA (mRNA) vaccines, mRNA-1975 and mRNA-1982, developed by Moderna. Tonix Pharmaceuticals has also licensed a preventative monoclonal antibody (mAb), TNX-4800 which targets the outer surface protein of Borrelia burgdorferi. The drug was developed by researchers at UMass Chan Medical School.
As a result, the Lyme disease market is saturated with generic drugs, and the penicillin-binding protein (PBP) inhibitor drug class as a treatment for Lyme disease.
A GlobalData report predicts cases of Lyme disease to rise very slightly from 353,932 in 2024 to 355,024 in 2029 across the 13 major pharmaceutical markets (13MM: the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China, India, Mexico, Russia, and South Korea).
GlobalData is the parent company of Clinical Trials Arena.
