Biofabri and Bharat Biotech International Limited (BBIL) have signed a technology transfer agreement aimed at improving worldwide access to the promising TB vaccine candidate, MTBVAC. The partnership marks an important step toward addressing one of the deadliest infectious diseases that continues to claim over a million lives every year, mostly in low- and middle-income countries.
Tuberculosis remains a huge public health challenge despite decades of efforts. The existing BCG vaccine, which is more than 100 years old, offers limited protection, especially in adolescents and adults. At the same time, the global TB vaccine pipeline is worryingly thin, with very few late-stage candidates and minimal private-sector investment. Against this background, MTBVAC has emerged as a critically important advance, being one of only two TB vaccine candidates to reach advanced clinical development.
The newly signed Technology Transfer Agreement builds upon a Licensing Agreement signed between the two companies in 2022. With this move, the collaboration enters a more operational phase, focusing on enabling end-to-end manufacturing of MTBVAC at Bharat Biotech. The technology transfer process has already started and is designed to ensure that BBIL is fully manufacturing-ready by the time MTBVAC receives licensure in India.
A key objective of the agreement is to support World Health Organization (WHO) priorities around equitable access. By establishing sustainable manufacturing capacity in high TB-burden regions, the partnership directly aligns with the WHO Finance and Access Working Group Solution, which calls for licensing and technology transfer of new TB vaccines to manufacturers in high-burden countries. Under this arrangement, Bharat Biotech will guarantee production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia, regions that carry a disproportionate share of the global TB burden.
MTBVAC has already completed Phase I and Phase II clinical trials in India, where it demonstrated a favourable safety profile and strong immunogenicity. Encouraged by these results, Bharat Biotech is now preparing for a pivotal Phase III efficacy trial, expected to begin participant recruitment in the first quarter of 2026. Given India’s high TB burden, MTBVAC is seen as a strong potential contributor to the TB Mukt Bharat initiative championed by the Hon’ble Prime Minister of India.
Scientifically, MTBVAC represents a unique approach. Designed by Dr. Carlos Martín of the University of Zaragoza and Dr. Brigitte Gicquel of the Institut Pasteur in Paris, and licensed to Biofabri, it is the only live, attenuated Mycobacterium tuberculosis vaccine currently in the pipeline. Unlike other candidates, MTBVAC contains the full set of antigenic targets of the original pathogen, which could translate into broader and more effective protection. The vaccine is being developed by Biofabri in close collaboration with Bharat Biotech and partners including IAVI, Fundação Ataulpho de Paiva (FAP), TB Vaccine Initiative (TBVI) and UNIZAR. It is intended for use in newborns, adolescents and adults groups that currently lack an effective prophylactic TB vaccine.
Commenting on the agreement, Esteban Rodríguez, CEO of Biofabri, said that the partnership represents “a decisive step toward ensuring that this vaccine reaches the populations that need it most.” He emphasized that enabling sustainable manufacturing in high-burden countries is essential to improving equitable access and responding to the global call from organisations like the WHO for new and effective TB tools.
Dr. Krishna Ella, Executive Chairman of Bharat Biotech, highlighted the company’s long-standing focus on innovation and access. He noted that MTBVAC reflects Bharat Biotech’s commitment to protection, dignity and a healthier future for millions at risk of tuberculosis. According to him, the upcoming Phase III trial in India is a vital milestone, and the implementation of the technology transfer marks a crucial progression toward comprehensive manufacturing of MTBVAC at Bharat Biotech, enabling global access and strengthening TB control efforts. He also added that while Phase I and II trials have been successfully completed, preparations for Phase III are now actively underway.
As TB continues to pose a serious threat to global health, especially in vulnerable populations, the Biofabri–Bharat Biotech collaboration offers renewed optimism. By combining advanced science, large-scale manufacturing and a clear focus on equity, the agreement could play an important role in reshaping the future of tuberculosis prevention worldwide.
