Pfizer and Valneva reported that their Lyme disease vaccine reduced cases by roughly 73% in a large Phase 3 trial but failed to meet the trial’s pre‑specified statistical threshold because the confidence interval fell short. Company statements and STAT reporting say the shortfall was driven in part by fewer‑than‑anticipated Lyme cases in the study population. Despite the statistical miss, Pfizer and Valneva said they will pursue regulatory filings, arguing the safety profile and point estimate support approval discussions with regulators including the FDA. A failed primary endpoint here means the trial’s estimate lacked the pre‑defined statistical certainty despite a sizable point estimate of efficacy.