Valneva SE announced today that it continues co-developing VLA15, a Phase 3 vaccine candidate, the only Lyme disease program in late-stage clinical development.
VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia, representing the most common serotypes found in the United States and Europe.
On August 12, 2025, Valneva confirmed its development partner, Pfizer Inc., is currently executing the randomized, placebo-controlled Phase 3 field efficacy study. The participants will be monitored for the occurrence of Lyme disease cases until the end of the 2025 Lyme disease season in the U.S. (end of October), with topline data expected as soon as all Lyme disease cases are confirmed.
In a press release, Valneva wrote that Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.
Lyme disease is the most common tickborne disease in the United States and Europe.
Lyme disease remains an expanding health risk in the U.S. It is a bacterial illness transmitted to humans through the bite of infected ticks. These ticks become infected by feeding on animals that carry the bacteria in their blood.
Over 89,000 cases of Lyme disease were reported to the U.S. CDC by state health departments and the District of Columbia in 2023. Recent estimates using other methods suggest that approximately 476,000 people may be diagnosed and treated for Lyme disease each year in the U.S.
The incidence of Lyme disease in Europe is highest in the Scandinavian and Baltic states in northern Europe and Austria, the Czech Republic, Germany, and Slovenia in central Europe.