Global pharma giant Pfizer and Valneva have announced encouraging topline results from the Phase 3 VALOR clinical trial of their investigational 6-valent OspA-based Lyme disease vaccine.

 

The trial, targeting outdoor recreationists, showed the vaccine achieved: 73.2% efficacy from 28 days post-dose 4 in reducing confirmed Lyme disease cases versus placebo; 74.8% efficacy from 1 day post-dose 4 versus placebo.

 

Although fewer Lyme disease cases than expected were observed and the primary endpoint’s strict statistical criterion was not met, Pfizer emphasized the results are clinically meaningful. The company plans to submit the vaccine for regulatory review.

 

“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, 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.”

 

“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.

 

Developed collaboratively by Pfizer and Valneva, PF-07307405, the vaccine, is being evaluated for efficacy, safety, tolerability, immunogenicity, and manufacturing consistency. Under a 2020 co-development agreement, Pfizer will exclusively manufacture and commercialize the vaccine, pending regulatory approval.