The two companies have 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.

“These results bring us a step closer to our goal of delivering a much-needed vaccine to help protect against Lyme disease,” says Thomas Lingelbach, CEO and Board member of Valneva.

The trial demonstrated in the pre-specified analyses, an 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, as well as an 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.

Planning submissions to regulatory authorities

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, it states.

“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,” says Annaliesa Anderson, Senior Vice President and Chief Vaccines Officer, Pfizer.

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.