Pfizer and Valneva Lyme Disease Vaccine Shows 73% Efficacy in Phase 3 Trial — Potential First-in-Class

Pfizer and Valneva reported their Lyme disease vaccine candidate (PF-07307405) demonstrated 73.2% efficacy from 28 days after the fourth dose in Phase 3 trials involving ~9,400 participants aged 5+ across endemic regions in Europe, Canada, and the United States. An initial analysis fell short of the 20% confidence interval threshold, but a second analysis achieved 'clinically meaningful efficacy' with a 21.7% lower bound. There is currently no approved human Lyme disease vaccine, making this a potential first-in-class product. Lyme is endemic across Central Europe including the Czech Republic. Pfizer is planning regulatory submissions.