Gates Medical Research Institute (Gates MRI) and Serum Institute of India (SII) have formalized a manufacturing agreement for M72/AS01E, a tuberculosis vaccine candidate that could become the first new TB vaccine in over a century. SII will invest more than $100 million to scale production, positioning itself to meet global demand if regulatory approvals follow successful Phase III trials.
Why This TB Vaccine Partnership Matters for Global Health and Investors
The collaboration leverages SII’s WHO-prequalified manufacturing capabilities to produce M72/AS01E at scale, targeting adults and adolescents in high-burden countries. GSK, the vaccine’s original developer, will supply the AS01E adjuvant, while Gates MRI sponsors the ongoing Phase III trial—funded by the Gates Foundation and Wellcome.
Technology transfer for antigen production has already begun, ensuring readiness for large-scale distribution. This proactive approach aims to accelerate supply if the trial, which enrolled 20,000 participants across five countries, yields positive results.
Clinical Efficacy and Market Potential
Prior Phase 2b trials showed M72/AS01E provided ~50% protection against active pulmonary TB in HIV-negative adults over three years. The WHO estimates a vaccine with this efficacy could:
- Prevent 76 million new TB cases
- Save 8.5 million lives
- Generate $41.5 billion in savings for affected households over 25 years
With TB remaining the world’s deadliest infectious disease, this partnership underscores the economic and humanitarian stakes of scaling a proven vaccine candidate.
