Pfizer and Valneva said their Phase III Valor trial showed the Lyme disease vaccine candidate achieved about 73% efficacy but missed a prespecified statistical criterion, a result the partners blamed on lower‑than‑expected infection rates during the study. Despite the statistical miss, both companies signaled intent to pursue regulatory submissions, citing a favorable safety profile and clinically meaningful protection. The outcome frames a tricky regulatory path: efficacy signals are strong, but the primary analysis shortfall could complicate reviews by agencies that require predefined statistical thresholds.