Pfizer and Valneva reported phase III results showing >70% efficacy for their Lyme disease vaccine candidate but said the trial failed to meet a pre‑specified statistical criterion because observed case numbers were lower than planned. The companies blamed fewer than expected infections during the trial window and said they still plan regulatory submissions, arguing the overall efficacy and safety profile support approval. The outcome creates a nuanced regulatory pathway: agencies will weigh robust point estimates and safety data against the missed statistical threshold when assessing licensure and public‑health recommendations.