Lyme disease vaccine proving effective in trials

NEW YORK & LYON, France—Pfizer Inc. and Valneva SE recently announced topline results from the Phase 3 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).

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,” said Annaliesa Anderson, Ph.D., senior vice president and chief vaccines officer, Pfizer. “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.”

“These results bring us a step closer to our goal of delivering a much-needed vaccine to help protect against Lyme disease,” said Thomas Lingelbach, CEO and board member of Valneva. 

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 license agreement in April 2020 for the co-development of PF-07307405 and for Pfizer to exclusively manufacture and commercialize PF-07307405, assuming regulatory success.

SOURCE Pfizer