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Human vaccine developer Biofabri, part of Spain’s Zendal group, and Bharat Biotech International (BBIL) have signed a technology transfer agreement for the tuberculosis vaccine MTBVAC.
About MTBVAC
MTBVAC is the only live, attenuated Mycobacterium tuberculosis vaccine currently in development. Biofabri is developing the vaccine in collaboration with Bharat Biotech International, IAVI, Fundação Ataulpho de Paiva, TB Vaccine Initiative, and University of Zaragoza.
The vaccine is intended for newborns, adolescents, and adults, population groups for which no effective preventive TB vaccine currently exists.
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Current Status
MTBVAC has completed Phase I and Phase II clinical trials in India, demonstrating safety and immunogenicity. Based on these results, Bharat Biotech International is preparing to initiate a pivotal Phase III efficacy trial, with participant recruitment expected to begin in the first quarter of 2026.
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Benefits
- The technology transfer agreement is an essential step toward expanding TB vaccine availability for high-burden populations, thus ensuring equitable access.
- The agreement aligns with the WHO Finance and Access Working Group Solution, which promotes licensing and technology transfer to at least one manufacturer in high-burden regions.
- Bharat Biotech International will produce and supply MTBVAC in more than 70 African and Southeast Asian countries with high TB burden.
- MTBVAC will contribute to the TB Mukt Bharat initiative.
- Technology transfer is essential to establishing full-scale manufacturing of MTBVAC in India.
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DhruvStar Industry Insights: What It Means for the Biotechnology Sector
1) Wider Vaccine Access
The MTBVAC agreement highlights the growing role of technology transfer to Indian manufacturers in expanding vaccine availability in high-burden countries. Indian biotech firms with proven manufacturing capacity are likely to play a larger role in global public health supply chains.
2) TB Vaccine Development Is Entering the Scale-Up Stage
With MTBVAC moving toward Phase III trials, the focus is shifting from research to large-scale manufacturing and deployment. This creates opportunities for industry players in clinical trials, manufacturing infrastructure, and regulatory support.
Sources
[1] The Hindu
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