Valneva SE announced positive final immunogenicity and safety data from Phase 2 study, VLA15-221, of Lyme disease vaccine candidate, VLA15. The results showed strong anamnestic immune response and favorable safety profile six months after a third booster dose (month 48) in all age groups, confirming compatibility with the anticipated benefits of a yearly vaccination prior to each Lyme season. Pfizer and Valneva entered into a collaboration agreement in April 2020 for the development and commercialization of VLA15 by Pfizer.
There are currently no approved human vaccines for Lyme disease, and VLA15 has advanced the furthest in clinical development, with all vaccinations completed in the pivotal VALOR Phase 3 trial1. The Centers for Disease Control and Prevention (CDC) estimates that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year2, and 132,000 cases are reported annually in Europe. Subject to positive Phase 3 data, Pfizer aims to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026.
Subject to positive Phase 2 data, Pfizer aims to submitted a Biologics License Application ("BLA") to the U.S. food and Drug Administration (FDA). Marketing Authorization Application (MAA") to the European Medicines Agency ("EMA") in 2026. The final Phase 2 data are consistent with those reported previously4,5 and confirm the potential benefits of booster doses across all evaluated age groups.
Lyme disease continues to expand geographically and remains a pressing unmet medical need affecting communities across the Northern Hemisphere. No safety concerns were observed by the independent DMC in any vaccination or age group.
