Pfizer and Valneva reported Phase 3 data showing their Lyme disease vaccine reduced cases by roughly 70–73% but failed to meet the trial’s pre‑specified statistical threshold because fewer than expected infections occurred. Both companies said efficacy and safety signals were clinically meaningful and that they plan to seek regulatory approval despite the primary analysis miss. The result raises a regulatory debate over prespecified endpoints versus totality of evidence; regulators will assess the clinical relevance alongside statistical methodology.