Serum Institute to manufacture potential first TB vaccine in over 100 years under Gates MRI deal

If approved, M72/AS01E could become the first new TB vaccine introduced in more than a century, marking a major breakthrough against a disease that remains the world's deadliest infectious killer and disproportionately affects low- and middle-income countries, SII said in a statement.

The partnership is aimed at ensuring that, if the vaccine receives regulatory approval, it can be manufactured at scale and made available quickly to adults and adolescents in countries with a high TB burden.

SII was selected for its proven expertise in producing WHO-prequalified vaccines at affordable prices and on a large scale while meeting stringent global quality and regulatory standards. The company also shares Gates MRI's commitment to equitable global access and plans to work with local manufacturers in Indonesia and South Africa to strengthen key parts of the vaccine supply chain over time.

As part of the collaboration, Gates MRI and SII will begin transferring the technology and manufacturing know-how required to produce the vaccine antigen, laying the foundation for future large-scale production of M72/AS01E. SII expects to invest more than US$100 million of its own resources to expand manufacturing readiness and build production capacity to support future global supply.

GSK, the original developer of the vaccine, will continue to supply the AS01E adjuvant, a key component of the vaccine.

The partners said beginning manufacturing preparations ahead of the Phase 3 trial results is a strategic move designed to ensure the vaccine can be produced and distributed rapidly if the trial proves successful and regulatory approvals are secured.

Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E with funding from the Gates Foundation and Wellcome. The double-blind, randomized study began in March 2024 and completed enrollment in April 2025, with 20,000 participants across 54 trial sites in South Africa, Kenya, Malawi, Zambia, and Indonesia.

Earlier Phase 2b trial results, sponsored by GSK, showed that M72/AS01E provided approximately 50 percent protection against progression to active pulmonary tuberculosis over a three-year follow-up period in TB-infected, HIV-negative adults aged 18 to 50 years.

According to the World Health Organization (WHO), a TB vaccine with this level of efficacy could prevent 76 million new TB cases, save 8.5 million lives, and reduce household costs associated with TB by US$41.5 billion over the next 25 years.