Pfizer and Valneva Complete Primary Vaccination Series in Lyme Disease Trial
Pfizer and Valneva announced that participants in the Phase 3 VALOR trial for their Lyme disease vaccine candidate, VLA15, have completed the primary three-dose vaccination series.
New York and Saint-Herblain, France – Pfizer Inc. and Valneva SE announced on July 17, 2024, that participants in the Phase 3 VALOR trial for Lyme disease vaccine candidate VLA15 have completed the primary three-dose vaccination series.
Participants will be monitored for Lyme disease cases through the end of the 2025 Lyme disease season. While efficacy is still under evaluation, the development of this vaccine candidate has progressed further than others in the field.
The VALOR trial is a multicenter study assessing the efficacy, safety, tolerability, and immunogenicity of VLA15. The vaccine targets the bacteria that cause Lyme disease and is designed to cover the most prevalent serotypes in North America and Europe.
Subject to positive data, Pfizer plans to seek regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2026. Currently, there are no approved human vaccines for Lyme disease.