• Vaccine candidate PF-07307405 (LB6V) demonstrated more than 70% efficacy in preventing Lyme disease in individuals aged five years and above
  • The investigational vaccine candidate was well tolerated with no safety concerns identified at time of analysis
  • Overall, results strengthen confidence in the vaccine candidate and Pfizer is planning submissions to regulatory authorities

Pfizer Inc. (NYSE:PFE) and Valneva SE (NASDAQ:VALN, 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:

  • 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 (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.