Bharat Biotech and Biofabri partner to develop, manufacture and distribute TB vaccine

Bharat Biotech yesterday announced the partnership with Biofabri, a Spanish biopharmaceutical company, to join forces to develop, manufacture and market a new tuberculosis vaccine in more than 70 countries in Southeast Asia and sub-Saharan Africa.

In a statement, Bharat Biotech said that the vaccine is being manufactured and developed by Biofabri, in close collaboration with the University of Zaragoza, IAVI and the Tuberculosis Vaccine Initiative (TBVI). MTBVAC, the novel vaccine for TV, has been designed and discovered by Carlos Martín team of the University of Zaragoza.

This agreement between Bharat Biotech and Biofabri would guarantee the worldwide production and the supply of the future vaccine in more than 70 countries with a high TB incidence, such as India, which has the highest TB burden in the world, with a 25 per cent of all cases, the statement said.

It also informed that MTBVAC is one of the most promising vaccine candidates in the current global TB vaccine pipeline. The only currently available TB vaccine, the Bacillus Calmette-Guérin vaccine (BCG), was developed 100 years ago and has limited efficacy in preventing pulmonary TB in adults, who, along with adolescents, are the biggest spreaders of the disease.

“TB infects more than 20 per cent of the global population, and is the second leading cause of deaths from infectious disease after COVID-19. TB is a highly contagious disease where vaccines are the best solution to prevent disease, reduce transmission and combat multi-drug-resistant strains. ……Bharat Biotech has opted for this vaccine candidate owing to its advanced stage of clinical development as well as the promising results from phase-I and phase-II clinical trials,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, in the statement.

“For us, this agreement is a milestone in the MTBVAC project. From day one, our goal has been to make a vaccine accessible to everyone at affordable prices in middle- and low-income countries where the incidence of tuberculosis is high. The contract signed with Bharat Biotech ensures that our vaccine reaches countries such as India, Indonesia, the Philippines, Pakistan and South Africa, among others, where tuberculosis is a public health problem due to its high incidence,” said Esteban Rodríguez, CEO, Biofabri, in the statement.

“……….At the University of Zaragoza, we have been working in the search of a new TB vaccine since 1998, and, since 2008, in close partnership with Biofabri. Accelerating efficacy studies for TB vaccines that have shown better protection than BCG in different pre-clinical models and to be immunogenic and safe in humans, as is the case of MTBVAC, is possible as it has been done for COVID vaccines. The experience of Bharat will be a great help reinforcing collaboration with TBVI and IAVI. We are ready, as soon we can demonstrate that MTBVAC protects against pulmonary forms of TB, the sooner we can begin to save lives and to have a huge impact on TB pandemic, including multi-drug resist forms of TB,” explained Professor Carlos Martín in the statement, who is the principal investigator of TB Vaccine project of the University of Zaragoza, Spain.

MTBVAC is the only live attenuated vaccine against Mycobacterium tuberculosis in development. It is currently being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG for new-borns and, on the other hand, for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine. MTBVAC will start phase-III clinical trials in Senegal, South Africa and Madagascar in the second half of 2022, the statement concluded.