Pfizer and Valneva reported Phase III Valor results showing the Lyme disease vaccine reduced cases by roughly 70–73% but missed the trial’s prespecified statistical threshold because fewer than expected infections occurred during the study window. Both companies said they will still pursue regulatory filings, arguing efficacy and safety data are clinically meaningful despite the primary‑analysis miss. The companies attributed the shortfall to low case accrual rather than lack of vaccine effect, but investors reacted sharply to the statistical miss. The outcome sets up a nuanced regulatory review where agencies will weigh observed efficacy against the protocol’s predefined criteria and the public‑health need for a Lyme vaccine.