Pfizer and Valneva announced topline results from the phase-III VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial of its investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 (LB6V, formerly known as VLA15).

In the pre-specified analyses, the trial demonstrated efficacy of 73.2 percent from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm (95 percent CI 15.8, 93.5) and efficacy of 74.8 percent from one-day post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm (95 percent CI 21.7, 93.9).

Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion (95 percent confidence interval lower bound >20) was not met in the first pre-specified analysis (primary endpoint). Given the clinically meaningful efficacy and the fact that the 95 percent confidence interval lower bound was above 20 in the second pre-specified analysis, Pfizer is confident in the vaccine’s potential and is planning submissions to regulatory authorities.

“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 percent is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating,” said Annaliesa Anderson, PhD, Senior Vice President and Chief Vaccines Officer, Pfizer.

Developed in collaboration between Pfizer and Valneva, the investigational 6-valent OspA-based Lyme disease vaccine is being evaluated for its efficacy, safety, tolerability, immunogenicity and manufacturing lot consistency. The companies entered into a collaboration and licence agreement in April 2020 for the co-development of PF-07307405 and for Pfizer to exclusively manufacture and commercialise PF-07307405, assuming regulatory success.

 “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,” said Thomas Lingelbach, CEO and Board Member, Valneva.