Biofabri, Bharat Biotech sign tech transfer deal for TB vaccine MTBVAC

New Delhi: Biofabri, a global human vaccine development company within Spain’s Zendal Group, and Bharat Biotech International Limited (BBIL), a leading global vaccine innovator and manufacturer, have signed a Technology Transfer Agreement to advance the development and global access of the tuberculosis vaccine candidate MTBVAC.

The agreement marks an important step in expanding equitable access to next-generation TB vaccines, in line with priorities set by the World Health Organization (WHO). It builds on a Licensing Agreement signed in 2022 and further strengthens the collaboration between the two companies. The technology transfer process is already underway to ensure Bharat Biotech’s manufacturing readiness ahead of MTBVAC’s licensure in India.

Driven by a shared commitment to global health, the initiative aims to make MTBVAC accessible, affordable, and equitably available—particularly in countries with the highest TB burden. The partnership aligns with the WHO Finance and Access Working Group’s solution to accelerate adult and adolescent TB vaccine access through licensing and technology transfer to manufacturers in high-burden regions.

Under the agreement, Bharat Biotech will manufacture and supply MTBVAC to more than 70 countries across Africa and Southeast Asia, regions that account for a significant share of the global tuberculosis burden.

MTBVAC has successfully completed Phase I and Phase II clinical trials in India, demonstrating safety and immunogenicity. Based on these results, Bharat Biotech is preparing to initiate a pivotal Phase III efficacy trial, with participant recruitment expected to begin in the first quarter of 2026. Given India’s high TB burden, MTBVAC is positioned as a promising candidate within the Government of India’s TB Mukt Bharat initiative.

MTBVAC was developed by Dr. Carlos Martín of the University of Zaragoza (UNIZAR) and Dr. Brigitte Gicquel of the Institut Pasteur, Paris, and licensed to Biofabri. It is the only live, attenuated Mycobacterium tuberculosis vaccine currently in the global pipeline and the only candidate containing the full antigenic repertoire of the original pathogen.

The vaccine is being developed by Biofabri in collaboration with Bharat Biotech, IAVI, Fundação Ataulpho de Paiva (FAP), the TB Vaccine Initiative (TBVI), and UNIZAR. MTBVAC is intended for use in newborns, adolescents, and adults—populations for which there is currently no effective prophylactic TB vaccine.

Commenting on the agreement, 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 for new tools to fight tuberculosis.”

Dr. Krishna Ella, Executive Chairman of Bharat Biotech, added: “Innovation and access are fundamental to our mission. MTBVAC reflects our commitment to protecting millions at risk of tuberculosis. The upcoming Phase III trial in India is a critical milestone, and this technology transfer marks a significant step toward establishing end-to-end manufacturing of MTBVAC at Bharat Biotech to support global TB control efforts.”