Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) on Wednesday announced positive Phase 2 results for its Lyme disease vaccine candidate, VLA15.
Data showed a strong anamnestic immune response and a favourable safety profile following a third annual booster dose in children and adults.
The results demonstrated significant antibody responses across all six serotypes, with 100% seroconversion rates reported in all age groups. Safety and tolerability remained consistent with previous boosters, with no concerns raised by the independent Data Monitoring Committee.
VLA15 remains the most advanced Lyme disease vaccine in development, with two Phase 3 trials ongoing. Vaccination in these studies has been completed and, subject to favourable results, Pfizer (NYSE:PFE) aims to file regulatory applications with the US Food and Drug Administration and the European Medicines Agency in 2026.
According to the Centers for Disease Control and Prevention, Lyme disease affects around 476,000 people annually in the United States, with 132,000 reported cases in Europe. VLA15 is being studied in both adults and children across endemic regions in North America and Europe.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval