Biofabri, a global human vaccine development company within the Zendal group, and Bharat Biotech International Limited (BBIL), a leader in vaccine innovation and manufacturing, have announced the signing of a Technology Transfer Agreement aimed at expanding equitable access to tuberculosis vaccines worldwide.

The agreement marks a major step in the collaboration between the two companies, following a Licensing Agreement signed in 2022. The technology transfer process is already underway to ensure BBIL is ready to manufacture MTBVAC once licensure is granted in India.

Driven by a shared commitment to global health, the initiative seeks to make MTBVAC accessible, affordable, and equitably available—especially in countries with the highest TB burden. The move aligns with the World Health Organization Finance and Access Working Group Solution, which supports licensing and technology transfer of novel TB vaccines to manufacturers in high-burden regions.

Under the agreement, BBIL will guarantee production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia.

MTBVAC, the only live, attenuated Mycobacterium TB vaccine in development, has successfully completed Phase I and II clinical trials in India, demonstrating safety and immunogenicity. BBIL is now preparing for a pivotal Phase III vaccine efficacy study, expected to begin recruitment in the first quarter of 2026.

With India facing a significant TB burden, MTBVAC is positioned as a leading candidate in the TB Mukt Bharat initiative, championed by thePrime Minister of India.

Designed by Dr Carlos Martín from the University of Zaragoza and Dr Brigitte Gicquel of the Institut Pasteur, and licensed to Biofabri, MTBVAC contains the full complement of the original pathogen's antigenic targets. The vaccine is being developed in collaboration with BBIL, IAVI, Fundação Ataulpho de Paiva, TB Vaccine Initiative, and UNIZAR, targeting newborns, adolescents, and adults—populations currently without effective TB prophylaxis.

Esteban Rodríguez, CEO of Biofabri, said: “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.”

Krishna Ella, Executive Chairman of Bharat Biotech, added: “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 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.”