Benzinga·2025-11-26 17:30Core Insights - Valneva SE has released final immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, indicating a strong immune response and favorable safety profile six months after a third booster dose [1][2][4] Vaccine Efficacy and Safety - The study demonstrated a robust anamnestic immune response across all age groups, confirming the vaccine's compatibility with the expected benefits of annual vaccination before Lyme season [2][4] - Antibody levels remained significantly higher with a three-dose primary vaccination schedule compared to a two-dose schedule, with geometric mean fold rises (GMFRs) ranging from 9.5-fold for Serotype 1 (ST1) to 15.6-fold for Serotype 2 (ST2) [5][6] - The highest GMFRs were observed in the 5 to 11-year-old age group, with levels ranging from 15.5-fold (ST1) to 28.5-fold (ST2), further validating the three-dose schedule and yearly booster [6] Regulatory Pathway - Pfizer aims to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to the European Medicines Agency in 2026, contingent on positive Phase 3 data [4] Operational Strategy - Valneva announced a strategic initiative to optimize its organizational footprint in France, planning to consolidate operations at its Lyon location and close the Nantes site [7] Market Reaction - Following the announcement, Valneva shares increased by 7.65%, reaching $9.19 [8]