Pfizer and Valneva Report Strong Immune Responses from Second Lyme Disease Vaccine Booster
Strong Immune Response:
Pfizer and Valneva announced positive results from their Phase 2 study, showing a strong immune response in both children and adults one month after a second booster dose of their Lyme disease vaccine candidate, VLA15.
Vaccine Candidate Details:
VLA15 is a hexavalent vaccine targeting the six most prevalent serotypes of Lyme disease in North America and Europe. It has shown favorable safety and tolerability profiles across all trials to date.
Clinical Trials:
The companies are conducting two Phase 3 trials, including the VALOR study, which aims to investigate the efficacy, safety, and immunogenicity of VLA15 in participants aged five years and older in highly endemic regions in the U.S. and Europe.
FDA Submission:
Pfizer and Valneva are targeting a 2026 FDA submission for VLA15, aiming to address the significant unmet medical need for a Lyme disease vaccine.
Collaboration:
Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms made in June 2022.