Pfizer And Valneva Report Strong Phase 3 Efficacy For Investigational Lyme Disease Vaccine, Plan Regulatory Submissions

Pfizer Inc. and Valneva SE have reported topline findings from the Phase 3 VALOR clinical trial evaluating their investigational Lyme disease vaccine candidate, PF-07307405 (also known as LB6V). The large-scale study assessed the vaccine’s performance in preventing Lyme disease among individuals at risk of tick exposure and marks a major step toward a potential first-in-class immunisation option.

“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 of Valneva.

In prespecified analyses, the vaccine demonstrated 73.2% efficacy in preventing confirmed Lyme disease cases, starting 28 days after the fourth dose, during the second season of evaluation, compared with placebo. A second analysis showed 74.8% efficacy beginning one day after the fourth dose in the same season. Although the number of Lyme cases recorded during the study was lower than expected, which affected statistical power, the second analysis met the predefined success threshold, while the primary endpoint narrowly missed it.

“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% is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating.”

Despite this, both companies consider the efficacy clinically meaningful and plan to move forward with regulatory submissions. The vaccine, developed through a collaboration established in April 2020, is being studied for safety, tolerability, immune response, and manufacturing consistency. Under the agreement, Pfizer will hold exclusive global manufacturing and commercialization rights, pending regulatory approvals.