Biofabri, Bharat Biotech ink tech transfer pact for MTBVAC tuberculosis vaccine

Human vaccine development company Biofabri, which is a part of Spain’s Zendal group, and Hyderabad-based vaccine maker Bharat Biotech International (BBIL) announced on Monday (December 22, 2025) signing of a technology transfer agreement for tuberculosis vaccine candidate MTBVAC.

The agreement follows the signing of a licensing agreement in 2022 and reinforces their partnership. The technology transfer process has already begun to ensure BBIL’s manufacturing readiness by the time of MTBVAC licensure in India, they said in a joint release.

Designed by Carlos Martín from the University of Zaragoza (UNIZAR) and Brigitte Gicquel of the Institut Pasteur in Paris and licensed to Biofabri, MTBVAC is the only live, attenuated Mycobacterium TB vaccine in the pipeline. MTBVAC is being developed by Biofabri, in collaboration with BBIL, IAVI, Fundação Ataulpho de Paiva (FAP), TB Vaccine Initiative (TBVI) and UNIZAR.

The vaccine is being targeted for newborns, adolescents and adults—groups for whom there is currently no effective prophylactic vaccine against TB disease. Bharat Biotech will guarantee production and supply of MTBVAC in more than 70 countries across Africa and Southeast Asia, regions with a high disease burden.

The signing of the agreement aligns with the WHO Finance and Access Working Group Solution that seeks 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.

MTBVAC has undergone Phase I and II clinical trials in India. The vaccine candidate has demonstrated safety and immunogenicity. Based on the initial results, BBIL is preparing for a pivotal Phase III vaccine efficacy study, which is expected to begin recruiting participants in the first quarter of 2026. Considering the significant disease burden in India, MTBVAC is poised to be a leading candidate in the TB Mukt Bharat initiative championed by Prime Minister Narendra Modi, the companies said.

The implementation of the technology transfer signifies a crucial progression towards establishing comprehensive manufacturing of MTBVAC at Bharat Biotech, thereby enabling worldwide access and bolstering tuberculosis control initiatives. The forthcoming Phase 3 trial in India, the country with the highest disease burden, constitutes a vital step in enhancing the global response to tuberculosis and its effects, said Bharat Biotech Executive Chairman Krishna Ella.

Biofabri CEO Esteban Rodriguez said the agreement represents a decisive step ensuring the vaccine reaches the populations that need it most. Enabling sustainable manufacturing in high-burden countries is essential to improving equitable access.