Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial
Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced topline results from the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (NCT05477524) of its investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 (LB6V, formerly known as VLA15) demonstrating:
- 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 (95% CI 15.8, 93.5)
- 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 (95% CI 21.7, 93.9)
Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion (95% 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% 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% 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 in collaboration between Pfizer and Valneva1,2 , 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 PF07307405, assuming regulatory success.
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Valneva Media Contacts:
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