Core Insights - Valneva SE announced positive final immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, confirming strong immune response and safety six months after a third booster dose [1][3][4] - VLA15 is the furthest advanced Lyme disease vaccine in clinical development, with pivotal Phase 3 trials ongoing and plans for regulatory submissions in 2026 [2][5] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [9][11] - The company has a strong track record in advancing vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [10] Vaccine Development - VLA15 is a multivalent protein subunit vaccine targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease, and covers the six most prevalent OspA serotypes in North America and Europe [5][8] - The Phase 2 study, VLA15-221, included a pediatric population and demonstrated that antibody levels remained well above baseline across all serotypes and age groups six months after the third booster dose [6][7] Clinical Study Results - The study confirmed the benefits of a three-dose vaccination schedule and a yearly booster, with geometric mean fold rises (GMFRs) in antibody levels ranging from 9.5-fold to 15.6-fold across all age groups [3][4] - No safety concerns were observed by the independent Data Monitoring Committee (DMC) in any vaccination or age group, indicating a favorable safety profile [4][6] Market Context - There are currently no approved human vaccines for Lyme disease, with approximately 476,000 diagnoses in the U.S. and 132,000 cases reported annually in Europe, highlighting a significant unmet medical need [2][8] - The increasing geographic spread of Lyme disease underscores the importance of developing effective vaccination strategies [3][8]