Pfizer and Valneva reported Phase III Valor trial results showing roughly 70–73% efficacy against Lyme disease but missed the prespecified statistical boundary in the primary analysis because overall infection incidence was lower than projected. The partners said safety and efficacy signals remain meaningful and plan regulatory submissions despite the statistical miss. Companies attributed the primary endpoint miss to fewer-than‑expected Lyme cases during the study period rather than to lack of vaccine activity. Both firms confirmed plans to pursue regulatory review and argued the totality of evidence supports approval considerations. Regulators will need to weigh robust relative efficacy against the pretrial statistical plan; public‑health agencies such as the FDA and CDC could face scrutiny when determining licensure and subsequent vaccine recommendation policies.