Bharat Biotech International Ltd announced the commencement of clinical trials for the Tuberculosis vaccine MTBVAC on adults in India, marking a significant milestone in the fight against TB. Developed by the Spanish biopharmaceutical company Biofabri, MTBVAC represents the first vaccine against Tuberculosis derived from a human source.
Conducted in close collaboration with Biofabri, Bharat Biotech aims to evaluate the safety and immunogenicity of MTBVAC through these trials, with plans for a pivotal safety, immunogenicity, and efficacy trial scheduled for 2025.
MTBVAC serves a dual purpose: to potentially provide a more effective and long-lasting alternative to BCG for newborns, and to address the lack of an effective TB vaccine for adults and adolescents.
Esteban Rodriguez, CEO of Biofabri, hailed the trials as a significant step, particularly in a country like India where a substantial portion of global TB cases occur. Dr. Krishna Ella, Executive Chairman of Bharat Biotech, expressed optimism about the venture, emphasizing the importance of developing TB vaccines to combat one of the world’s leading infectious causes of death.
MTBVAC has already achieved several milestones before entering clinical trials in India, including Phase 2 and Phase 3 trials focusing on newborns and adults, respectively. Unlike BCG, MTBVAC is based on a genetically modified form of Mycobacterium tuberculosis isolated from humans, containing all relevant antigens present in human-infecting strains.
Tuberculosis remains a formidable global health challenge, claiming millions of lives annually. With its potential to enhance TB prevention strategies, MTBVAC represents a promising advancement in the field of vaccine development against this deadly disease.
