Bharat Biotech nears phase III trials for tuberculosis vaccine

Bharat Biotech International, an Indian vaccine manufacturer, is on the verge of launching phase III clinical trials for its Tuberculosis (TB) vaccine candidate, Mycobacterium Tuberculosis Vaccine (MTBVAC), following successful completion of two separate phase II trials. The Hyderabad-based company’s progress positions MTBVAC as one of the most promising candidates in the global TB vaccine pipeline.

TB, a highly infectious disease affecting over 20% of the world’s population, is the second leading cause of death from infectious diseases after Covid-19. Vaccines are seen as a crucial solution to prevent the disease, limit its transmission, and combat multi-drug resistant strains.

The two phase II trials for MTBVAC received backing from various international organizations. Biofabri sponsored the first trial, with support from The European & Developing Countries Clinical Trials Partnership (EDCTP), and was conducted on infants in South Africa. The second trial was sponsored by the International AIDS Vaccine Initiative (IAVI) and backed by the US National Institutes of Health and the US Department of Defence through its Congressionally Directed Medical Research Program.

MTBVAC aims to serve as a more effective vaccine than Bacille Calmette-Guerin (BCG) for newborns and to prevent TB disease in adults and adolescents who currently lack an effective vaccine. A standout feature of MTBVAC is its potential to prevent transmission or spread of the disease.

Following the completion of these phase II trials, Bharat Biotech is planning a Phase II safety/immunogenicity study of MTBVAC in people living with HIV (PWHIV). Phase III trials are anticipated to follow soon.

The partnership between Bharat Biotech and Biofabri, announced last year, could potentially result in a global production and supply of MTBVAC in over 70 countries with high TB incidence if successful. India, home to 25% of all TB cases globally, would be a primary beneficiary of this vaccine.

The current global TB vaccine landscape features only one other candidate, M72, developed by GSK in collaboration with Aeras and the International AIDS Vaccine Initiative (IAVI), which is expected to enter phase III trials in 2024. If Bharat Biotech commences its phase III trials soon, it could take the lead in this race.

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