Biofabri and Bharat Biotech Advance Technology Transfer for MTBVAC Tuberculosis Vaccine to Expand Global Access
Key Insights
Biofabri (search) and Bharat Biotech have signed a technology transfer agreement to expand global access to MTBVAC, the only live, attenuated Mycobacterium TB (search) vaccine currently in development.
The partnership will enable BBIL (search) to manufacture and supply MTBVAC to more than 70 countries across Africa and Southeast Asia, regions with the highest TB (search) burden.
MTBVAC has successfully completed Phase I and II clinical trials in India, demonstrating safety and immunogenicity, with a pivotal Phase III efficacy study expected to begin recruitment in Q1 2026.
Biofabri (search), a global human vaccine development company within the Zendal group (search), and Bharat Biotech International Limited (BBIL (search)) have announced a technology transfer agreement to expand equitable access to tuberculosis (search) vaccines worldwide. The partnership represents a significant advancement in the fight against TB (search), particularly targeting high-burden regions across Africa and Southeast Asia.
Strategic Partnership Builds on Previous Collaboration
The technology transfer agreement marks a major milestone in the collaboration between the two companies, following a licensing agreement signed in 2022. The technology transfer process is already underway to ensure BBIL (search) is ready to manufacture MTBVAC once licensure is granted in India.
Under the agreement, BBIL (search) will guarantee production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia. This initiative aligns with the World Health Organization Finance and Access Working Group Solution, which supports licensing and technology transfer of novel TB (search) vaccines to manufacturers in high-burden regions.
MTBVAC: A Novel Approach to TB Prevention
MTBVAC represents the only live, attenuated Mycobacterium TB (search) vaccine currently in development. Designed by Dr Carlos Martín from the University of Zaragoza and Dr Brigitte Gicquel of the Institut Pasteur, and licensed to Biofabri (search), MTBVAC contains the full complement of the original pathogen's antigenic targets.
The vaccine has successfully completed Phase I and II clinical trials in India, demonstrating safety and immunogenicity. BBIL (search) is now preparing for a pivotal Phase III vaccine efficacy study, expected to begin recruitment in the first quarter of 2026.
Targeting High-Burden Populations
The vaccine is being developed in collaboration with BBIL (search), IAVI (search), Fundação Ataulpho de Paiva (search), TB Vaccine Initiative (search), and UNIZAR (search), targeting newborns, adolescents, and adults—populations currently without effective TB (search) prophylaxis. With India facing a significant TB burden, MTBVAC is positioned as a leading candidate in the TB Mukt Bharat initiative, championed by the Prime Minister of India.
Industry Leadership Perspectives
Esteban Rodríguez, CEO of Biofabri (search), emphasized the significance of the partnership: "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 (search)."
Krishna Ella, Executive Chairman of Bharat Biotech, highlighted the company's commitment to global health: "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 (search). 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."
Manufacturing and Global Distribution Strategy
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 (search) control initiatives. Clinical development has successfully advanced through Phase I and Phase II trials, with Phase III preparations currently in progress.
The partnership is driven by a shared commitment to global health, seeking to make MTBVAC accessible, affordable, and equitably available—especially in countries with the highest TB (search) burden.