Pfizer and Valneva announced Monday that their Lyme disease vaccine candidate demonstrated over 70 percent efficacy in Phase 3 clinical trials. The candidate, PF-07307405, showed 73.2 percent effectiveness following the fourth dose among nearly 9,400 participants across the United States, Europe, and Canada.
Current market standards require at least 20 percent risk reduction. While initial analysis missed targets due to lower case numbers, a secondary review confirmed clinically meaningful protection. The vaccine was well-tolerated with no safety concerns identified.
With no approved human vaccines currently available, this development represents the furthest advancement in clinical timelines for Lyme disease prevention. Pfizer plans immediate regulatory submissions.
“Lyme disease can cause potentially serious consequences,” said Annaliesa Anderson, Pfizer’s senior vice president and chief vaccines officer.