Rapid Fire
Approval for Phase 2 Trials of MTBVAC
- 09 May 2024
- 1 min read
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.
