Bharat Biotech announced a 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.

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 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% of all cases.

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% 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. We are proud to announce this partnership with Biofabri, where MTBVAC can become a global TB vaccine. Bharat Biotech has opted for this vaccine candidate owing to its advanced stage of clinical development as well as the extremely promising results from Phase 1 and Phase 2 clinical trials." said Dr. Krishna Ella, Chairman and Managing Director Bharat Biotech.

“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, Biofabri CEO.

“We have a good hope that a new vaccine TB vaccine is in the horizon. At the University of Zaragoza, we 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 preclinical 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 as we can demonstrate that MTBVAC protects against pulmonary forms of TB, the sooner we can begin to save live and to have huge impact in TB pandemic, including multidrug resist forms of TB” explained Professor Carlos Martín, is principal investigator of TB Vaccine project of 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 newborns 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 3 clinical trials in Senegal, South Africa and Madagascar in the second half of 2022.