Pfizer and Valneva announced topline results from the Phase 3 VALOR trial (NCT05477524) of Lyme disease vaccine candidate PF-07307405 (LB6V), demonstrating 73.2% efficacy from 28 days post-dose 4 and 74.8% from 1-day post-dose 4 in preventing Lyme disease in individuals aged five years and above. Pfizer plans regulatory submissions despite fewer-than-anticipated cases preventing the primary endpoint from being met.
Key takeaways
Efficacy of 73.2% (95% CI 15.8-93.5) from 28 days post-dose 4 (season 2) vs placebo
Efficacy of 74.8% (95% CI 21.7-93.9) from 1-day post-dose 4 (season 2) vs placebo
Vaccine candidate well tolerated with no safety concerns identified
Fewer Lyme disease cases accrued than anticipated; primary endpoint statistical criterion not met in first analysis
Pfizer planning submissions to regulatory authorities
Trial conducted in individuals aged 5 years and older across US, Canada, Europe