Pfizer and Valneva new lyme disease vaccine candidate emphasises strong efficacy in phase 3 VALOR trial

Pfizer and Valneva have 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 demonstrating:

• In the pre-specified analyses:
  • Efficacy of 73.2% from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm
  • Efficacy of 74.8% from 1-day post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm

Note that fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion was not met in the first pre-specified analysis.

“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.”

“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.

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.

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Related Topics and Keywords

lyme disease, Pfizer, Phase 3 VALOR Trial, Valneva