Biofabri and Bharat Biotech have signed a technology transfer agreement that represents a milestone in advancing global efforts to expand equitable access to tuberculosis vaccines in line with the World Health Organisation (WHO) priorities.

Following the signature of the Licensing Agreement in 2022, this new technology transfer agreement reinforces the collaboration between the two companies. The technology transfer process has already begun to ensure Bharat Biotech's manufacturing readiness by the time of MTBVAC licensure in India.

The initiative aligns with the WHO Finance and Access Working Group Solution, which aims to accelerate equitable access of novel tuberculosis vaccines for adults and adolescents through licensing and technology transfer to at least one manufacturer in a high burden region.

Bharat Biotech will guarantee the production and supply of MTBVAC in over 70 countries across Africa and Southeast Asia, regions with a high disease burden.

MTBVAC has undergone phase I and phase II clinical trials in India. The vaccine candidate has demonstrated safety and immunogenicity. Based on these initial results, Bharat Biotech is preparing for a phase III vaccine efficacy study, which is expected to begin recruiting participants in the first quarter of 2026.

MTBVAC is designed by Dr Carlos Martín from the University of Zaragoza (UNIZAR) and Dr Brigitte Gicquel of the Institut Pasteur in Paris and licensed to Biofabri. MTBVAC is the only live, attenuated Mycobacterium TB vaccine in the pipeline and the only vaccine that contains the full complement of the original pathogen's antigenic targets.

As Esteban Rodríguez, CEO, Biofabri, stated, “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 WHO for new, effective tools to fight tuberculosis.”

MTBVAC is being developed by Biofabri, in close collaboration with Bharat Biotech, IAVI, Fundação Ataulpho de Paiva (FAP), TB Vaccine Initiative (TBVI) and UNIZAR.  MTBVAC is being targeted for two key populations: newborns, adolescents and adults—groups for whom there is currently no effective prophylactic vaccine against TB disease.

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 III 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, Bharat Biotech.