Hyderabad, India, 22nd, December 2025: Bharat Biotech has signed a major deal today with Biofabri to produce and distribute the MTBVAC tuberculosis vaccine, bringing new hope to the fight against TB. This partnership will help ensure that the vaccine reaches more than 70 countries, focusing on areas where tuberculosis is a major health threat, like Southeast Asia and Africa.
The agreement comes as part of a global effort to make TB vaccines more accessible to those who need them most. With Phase 3 trials set to begin in India in 2026, MTBVAC could play a key role in reducing the spread of tuberculosis, especially in high-risk communities.
Biofabri, a global human vaccine development company that is part of the Zendal group, and Bharat Biotech International Limited (BBIL), is a global leader in vaccine innovation and manufacturing.
The agreement represents a significant milestone in advancing global efforts to expand equitable access to tuberculosis vaccines in line with World Health Organization (WHO) priorities.
Following the signature of the Licensing Agreement in 2022, this new Technology Transfer Agreement reinforces the collaboration and partnership between the two companies. The Technology Transfer process has already begun to ensure BBIL’s manufacturing readiness by the time of MTBVAC licensure in India.
A shared commitment to global health drives the initiative and to ensure that MTBVAC is accessible, affordable and equitably available, particularly in countries with the highest tuberculosis burden. This initiative aligns with the WHO Finance and Access Working Group Solution, which aims to accelerate equitable access of novel tuberculosis vaccines for adults and adolescents through licensing and technology transfer to at least one manufacturer in a high burden region (1).
TB Vaccine Hope Grows with Biofabri-Bharat Biotech Deal
BBIL will guarantee the production and supply of MTBVAC in more than 70 countries across Africa and Southeast Asia, regions with a high disease burden.
MTBVAC has undergone Phase I and II clinical trials in India. The vaccine candidate has demonstrated safety and immunogenicity. Based on these initial results, Bharat Biotech is preparing for a pivotal Phase III vaccine efficacy study, which is expected to begin recruiting participants in the first quarter of 2026. Considering the significant disease burden in India, MTBVAC is poised to be a leading candidate in the TB Mukt Bharat initiative championed by the Hon’ble Prime Minister of India.
MTBVAC is designed by Dr. Carlos Martín from the University of Zaragoza (UNIZAR) and Dr. Brigitte Gicquel of the Institut Pasteur in Paris and licensed to Biofabri. MTBVAC is the only live, attenuated Mycobacterium TB vaccine in the pipeline and the only vaccine that contains the full complement of the original pathogen’s antigenic targets.
MTBVAC is being developed by Biofabri, in close collaboration with Bharat Biotech, IAVI, Fundação Ataulpho de Paiva (FAP), TB Vaccine Initiative (TBVI) and UNIZAR. MTBVAC is being targeted for two key populations: newborns, adolescents and adults, groups for whom there is currently no effective prophylactic vaccine against TB disease.
As Esteban Rodríguez, CEO of Biofabri stated: “This agreement represents a decisive step toward ensuring that this vaccine reaches the populations that need it most. Enabling sustainable manufacturing in high-burden countries is essential to improving equitable access and responding to the global call from organisations such as the World Health Organization for new, effective tools to fight tuberculosis.”
At Bharat Biotech, innovation and access are fundamental to our business and philosophy. MTBVAC exemplifies our dedication to protection, dignity, and a healthier future for millions at the risk of tuberculosis. The forthcoming Phase 3 trial in India, the nation with the highest disease burden, constitutes a vital step in enhancing the global response to tuberculosis and its effects. The implementation of this technology transfer signifies a crucial progression towards establishing comprehensive manufacturing of MTBVAC at Bharat Biotech, thereby enabling worldwide access and bolstering tuberculosis control initiatives. Clinical development has successfully advanced through Phase I and Phase II trials, with Phase III preparations currently in progress,” said, Dr. Krishna Ella, Executive Chairman of Bharat Biotech.
References
1. Catalysing solutions for equitable global access and sustainable financing for novel tuberculosis vaccines for adults and adolescents. Geneva: World Health Organization; 2025. Licence: CC BY-NC-SA 3.0 IGO.
