Bharat Biotech inks tech transfer pact with Biofabri for MTBVAC TB vaccine

Bharat Biotech has signed a technology transfer agreement with Spain's Biofabri to enable end-to-end manufacturing of MTBVAC, with a Phase 3 study in India expected to start recruitment in Q1 2026

Bharat Biotech International (BBIL) on Monday inked a technology transfer agreement with Spanish vaccine maker Biofabri to advance global access for MTBVAC, a vaccine candidate that has progressed into advanced clinical development for tuberculosis (TB) in newborns, adolescents and adults.

 

What does the new agreement add to the 2022 licensing deal? 

The pact comes three years after the companies first signed a licensing agreement in 2022. “The technology transfer process has already begun to ensure BBIL’s manufacturing readiness by the time of MTBVAC licensure in India,” the companies said in a statement.

 

They added that the partnership strengthens long-term collaboration by enabling technology transfer that supports end-to-end manufacturing of MTBVAC at Bharat Biotech.

 

Which regions will Bharat Biotech supply MTBVAC to? 

As part of the deal, Bharat Biotech will guarantee the production and supply of MTBVAC in more than 70 countries across Africa and Southeast Asia, which are regions with a high disease burden.

 

“The implementation of this technology transfer signifies a crucial progression towards establishing, thereby enabling worldwide access and bolstering tuberculosis control initiatives,” said Krishna Ella, executive chairman of Bharat Biotech.

 

Biofabri chief executive officer Esteban Rodriguez said the agreement represents a decisive step toward ensuring that the vaccine reaches the populations that need it most.

 

What is the clinical trial status and what comes next? 

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

 

Ella said 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.

 

How does MTBVAC link to TB Mukt Bharat and WHO access goals? 

“Considering the significant disease burden in India, MTBVAC is poised to be a leading candidate in the TB Mukt Bharat initiative championed by the Prime Minister of India,” the companies said.

 

While the companies did not disclose a cost range, they said the initiative aligns with the World Health Organization’s Finance and Access Working Group Solution, which aims to accelerate equitable access to novel tuberculosis vaccines for adults and adolescents through licensing and technology transfer to at least one manufacturer in a high-burden region.

 

How was MTBVAC developed and how does it differ from BCG? 

Bharat Biotech has previously said MTBVAC is the first vaccine against TB derived from a human source to begin clinical trials in adults in India.

 

The vaccine has been developed in the laboratory of the University of Zaragoza, in collaboration with Dr Brigitte Gicquel of the Pasteur Institute in Paris. The University of Zaragoza has the Spanish biotechnology company Biofabri as an industrial partner.

 

The only existing vaccine for TB is the 100-year-old Bacillus Calmette and Guérin (BCG) vaccine, which is an attenuated variant of the bovine TB pathogen and has a very limited effect on pulmonary tuberculosis, which is responsible for disease transmission.

 

“MTBVAC is being developed as a more effective and potentially longer-lasting vaccine than the BCG vaccine for newborns as well as for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine,” people in the know said.