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A significant partnership has been forged between the Gates Medical Research Institute (Gates MRI) and the Serum Institute of India Private Limited (SII) to manufacture a novel tuberculosis (TB) vaccine candidate, M72/AS01E.

This vaccine candidate is currently undergoing Phase 3 clinical trials and holds the potential to be the first new TB vaccine introduced in over a century. Its development marks a critical step towards combating a disease that remains the world's leading infectious cause of death, disproportionately affecting low- and middle-income countries.

The collaboration aims to ensure that, if approved, the vaccine can be produced at scale and made available to adults and adolescents in high-TB-burden countries as swiftly as possible. SII was chosen for its proven track record in producing WHO-prequalified vaccines affordably and at scale, while adhering to stringent global quality and regulatory standards.

Both Gates MRI and SII share a commitment to global access. SII plans to invest over $100 million of its own resources to enhance manufacturing readiness and capacity. The original developer, GSK, will provide the AS01E adjuvant. This proactive approach, initiating manufacturing preparations before Phase 3 trial results are finalized, is a strategic move to ensure readiness for global demand.

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This partnership marks a critical step toward ensuring that, if approved, the vaccine can be produced at scale and made available to adults and adolescents in countries with a high TB burden as soon as possible.