Approval for Phase 2 Trials of MTBVAC | 09 May 2024

Recently, The Central Drug Standard Control Organisation’s (CDSCO) has approved the proposal to conduct the phase II clinical trial of the Mycobacterium Tuberculosis (Live Attenuated) Vaccine.

The MTBVAC is the first vaccine against TB derived from a human source to begin clinical trials in adults in India.
Bharat Biotech International Limited in collaboration with Spanish biotechnology company Biofabri have started a series of clinical trials to evaluate the safety, immunogenicity, and efficacy of MTBVAC in India.
MTBVAC is being developed for two purposes as a more effective and potentially long-lasting vaccine than BCG (Bacillus Calmette and Guérin) for newborn children, and for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine.
MTBVAC is the only vaccine against tuberculosis in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis.
BCG is an only attenuated variant of the bovine TB pathogen which is older than a hundred years old and has a very limited effect on pulmonary tuberculosis.