Pfizer, Valneva announce ‘positive’ results from Phase 3 VALOR trial

Pfizer (PFE) and Valneva (VALN) announced topline results from the Phase 3 VALOR 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; 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. 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.