Hyderabad | December 22, 2025 : Bharat Biotech International Limited and Biofabri have signed a Technology Transfer Agreement aimed at expanding global access to MTBVAC, a tuberculosis vaccine candidate currently in advanced clinical development. The agreement is expected to strengthen manufacturing capacity in high-burden regions and support global tuberculosis control efforts aligned with World Health Organization (WHO) priorities.
Tuberculosis continues to rank among the world’s leading infectious disease killers, claiming more than a million lives each year, with the heaviest impact felt in low- and middle-income countries. Despite this burden, progress in vaccine development has been slow, with few candidates reaching late-stage trials and limited private-sector investment beyond the century-old BCG vaccine.
MTBVAC is one of only two tuberculosis vaccine candidates to reach advanced clinical development. The technology transfer agreement builds on a licensing agreement signed by the two companies in 2022 and marks the next phase of their collaboration. According to the companies, the transfer process has already begun to ensure Bharat Biotech’s manufacturing readiness by the time the vaccine receives licensure in India.
TB Vaccine for 70+ Countries: Bharat Biotech and Biofabri Sign MTBVAC Transfer Pact
Under the agreement, Bharat Biotech will be responsible for manufacturing MTBVAC for supply to more than 70 countries across Africa and Southeast Asia, regions with a high tuberculosis burden. The initiative is designed to support equitable access by enabling end-to-end manufacturing in a high-burden country, in line with WHO’s finance and access strategy for new TB vaccines.
MTBVAC has completed Phase I and Phase II clinical trials in India, where it demonstrated safety and immunogenicity. Based on these results, Bharat Biotech is preparing to launch a Phase III efficacy trial, with participant recruitment expected to begin in the first quarter of 2026. Given India’s tuberculosis burden, the vaccine is being positioned as a potential contributor to the government’s TB Mukt Bharat initiative.
The vaccine was developed by Dr. Carlos Martín of the University of Zaragoza and Dr. Brigitte Gicquel of the Institut Pasteur, and is licensed to Biofabri, part of the Zendal group. It is the only live, attenuated Mycobacterium tuberculosis vaccine currently in the global pipeline and contains the full range of antigenic targets found in the original pathogen.
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.
MTBVAC is being developed through a collaboration involving Biofabri, Bharat Biotech, IAVI, Fundação Ataulpho de Paiva, the TB Vaccine Initiative, and the University of Zaragoza. The vaccine is intended for use in newborns, adolescents, and adults, populations for which no effective preventive TB vaccine currently exists.
Commenting on the agreement, Biofabri CEO Esteban Rodríguez said the technology transfer would help ensure the vaccine reaches populations most affected by tuberculosis, adding that sustainable manufacturing in high-burden countries is critical for equitable access.
