Valneva has announced final positive immunogenicity and safety data from its Phase 2 study (VLA15-221) for the Lyme disease vaccine candidate VLA15, developed in partnership with Pfizer.
The results demonstrated a strong anamnestic immune response and a favorable safety profile six months after a third booster dose across all age groups, confirming the anticipated benefit of annual vaccination prior to each Lyme disease season.
As a reminder, Pfizer and Valneva entered into a collaboration agreement in April 2020 for the development and commercialization of VLA15 by the American group. VLA15 is currently the most advanced Lyme disease vaccine candidate, with two Phase 3 trials underway.
Subject to positive Phase 3 data, Pfizer plans to submit Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2026.