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  • Biofabri and Bharat Biotech Enter Landmark Agreement for Next-Gen TB Vaccine
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Biofabri and Bharat Biotech Enter Landmark Agreement for Next-Gen TB Vaccine

Pharm'Up 2 min read

In a transformative step for global public health, Biofabri and Bharat Biotech International Limited (BBIL) have finalized a Technology Transfer Agreement to manufacture and distribute MTBVAC, the world’s most advanced tuberculosis vaccine candidate.

This operational phase builds on their 2022 licensing deal, shifting the focus to high-volume, end-to-end manufacturing in India to meet the World Health Organization’s (WHO) call for equitable vaccine access.


Why MTBVAC is a Game-Changer

The current BCG vaccine is over a century old and offers limited protection for adults. MTBVAC stands out as the only live-attenuated Mycobacterium tuberculosis vaccine in the global pipeline.

Key Scientific Advantages:

  • Full Antigenic Profile: Unlike other candidates, it contains all the targets of the original pathogen for broader protection.
  • Broad Target Groups: Designed specifically for newborns, adolescents, and adults—the groups most responsible for TB transmission.
  • No Adjuvants Required: Derived directly from a human TB strain, it triggers a more durable immune memory without extra chemical boosters.

The Road to “TB Mukt Bharat” (TB-Free India)

India carries the world’s highest tuberculosis burden, making this partnership vital to the national “TB Mukt Bharat” initiative.

MilestoneTimeline/Status
Phase I & II Trials (India)Successfully completed (Safe & Immunogenic)
Technology TransferCurrently Underway
Phase III RecruitmentStarts Q1 2026
Manufacturing ReadinessExpected by licensure (Late 2026/2027)

Global Supply Commitment

Under the terms of the agreement, Bharat Biotech will guarantee the supply of MTBVAC to more than 70 countries across Africa and Southeast Asia.

“This partnership 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.” — Esteban Rodríguez, CEO of Biofabri.

Dr. Krishna Ella, Executive Chairman of Bharat Biotech, added that the upcoming Phase III trial is a “vital milestone” in strengthening the global response to a disease that still claims over a million lives annually.

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