Biofabri, Bharat Biotech agree to share tech to advance global access to MTBVAC TB vaccine

Hyderabad: Biofabri, a global human vaccine development company and part of the Zendal Group, and Bharat Biotech International Limited (BBIL) have signed a Technology Transfer Agreement aimed at advancing global access to MTBVAC, a next-generation tuberculosis (TB) vaccine candidate.

The agreement strengthens an existing partnership between the two companies and marks a key step towards establishing manufacturing capacity for MTBVAC in India, in alignment with World Health Organisation (WHO) priorities on equitable access to tuberculosis vaccines.

Persistent global health challenge

Tuberculosis remains one of the world’s leading infectious disease killers, accounting for over one million deaths annually, with low- and middle-income countries carrying the highest disease burden. Despite this, the global TB vaccine pipeline remains limited, with few candidates in advanced stages of development and minimal private-sector investment beyond the century-old BCG vaccine.

MTBVAC is one of only two TB vaccine candidates to have progressed into advanced clinical development, positioning it as a significant contender in global TB prevention efforts.

Strengthening manufacturing in high-burden regions

The Technology Transfer Agreement follows a Licensing Agreement signed in 2022 and reinforces long-term collaboration between Biofabri and Bharat Biotech.

The technology transfer process has already commenced to ensure Bharat Biotech’s manufacturing readiness ahead of the potential licensure of MTBVAC in India.

The initiative aligns with the WHO Finance and Access Working Group Solution, which seeks to accelerate equitable access to new TB vaccines through licensing and technology transfer to manufacturers in high-burden regions.

Under the agreement, Bharat Biotech will support the production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia, regions disproportionately affected by tuberculosis.

Clinical development and India’s role

MTBVAC has successfully completed Phase I and Phase II clinical trials in India, demonstrating safety and immunogenicity. Based on these outcomes, Bharat Biotech is preparing for a pivotal Phase III efficacy trial, expected to begin participant recruitment in the first quarter of 2026.

Given India’s high TB burden, MTBVAC is expected to play a role in the country’s TB Mukt Bharat initiative.

About MTBVAC

MTBVAC was designed by Dr Carlos Martín of the University of Zaragoza and Dr Brigitte Gicquel of the Institut Pasteur, Paris, and licensed to Biofabri.

It is the only live, attenuated Mycobacterium tuberculosis vaccine candidate currently in the global pipeline and contains the full complement of antigenic targets of the original pathogen.

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

What the companies say

Esteban Rodríguez, CEO of Biofabri, said the agreement was central to expanding access: “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.”

Dr Krishna Ella, Executive Chairman of Bharat Biotech, highlighted the significance of the next clinical phase: “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.”

He added, “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.”

Looking ahead

With technology transfer underway and Phase III trials approaching, the Biofabri–Bharat Biotech collaboration represents a coordinated effort to close critical gaps in tuberculosis prevention.

If successful, MTBVAC could become a key addition to global TB control strategies, particularly in countries bearing the highest disease burden.