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1 revisions for "Pfizer's Lyme Disease Vaccine Shows 70% Efficacy—But a Statistical Miss Clouds the Path to Approval"

Pfizer and Valneva announced their Lyme disease vaccine candidate demonstrated 73.2% efficacy in the Phase 3 VALOR trial involving roughly 9,400 participants across endemic regions of the U.S., Canada, and Europe. However, the trial's primary statistical endpoint was not met because fewer Lyme cases than expected produced a confidence interval below the required threshold, raising questions about the regulatory path forward for what would be the first Lyme vaccine in over two decades.