Gates MRI, Serum Institute ink deal to make potential new TB vaccine

Gates Medical Research Institute and Serum Institute of India have signed an agreement to manufacture a novel TB vaccine, M72/AS01E. Currently in Phase 3 trials, it has the potential to be the first new TB vaccine in over a century.

The Gates Medical Research Institute (Gates MRI) on Thursday signed an agreement with the Serum Institute of India Private Limited (SII) to manufacture a novel tuberculosis (TB) vaccine candidate M72/AS01E. Currently in a Phase 3 clinical trial, M72/AS01E has the potential to be the first new TB vaccine to be introduced in more than a century - a potential breakthrough against a disease that remains the world's leading infectious cause of death and disproportionately impacts low- and middle-income countries.

A Partnership for Global Access

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. SII was selected based on its strong track record of producing WHO-prequalified vaccines, affordably and at scale, and meeting stringent global quality and regulatory standards. They also share the M72 partners' commitment to global access and to engaging local manufacturers in Indonesia and South Africa to support critical parts of the supply chain over time.

Manufacturing Readiness and Investment

With this partnership, Gates MRI and SII will begin the process of transferring the technology and know-how required to manufacture the antigen and enable future large-scale production of M72/AS01E. SII expects to invest more than US$100 million of its own resources to strengthen manufacturing readiness and capacity building to support potential future supply. GSK, the original developer of the vaccine, will supply the AS01E adjuvant.

Initiating this work well ahead of Phase 3 trial results is a deliberate strategy to ensure readiness to produce and distribute the vaccine and begin meeting global demand as quickly as possible, should the trial be successful and regulatory approvals be granted.

Phase 3 Clinical Trial Underway

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

Proven Efficacy and Potential Impact

In a Phase 2b randomised, double-blind, placebo-controlled trial with 3,575 participants sponsored by the vaccine's developer, GSK, M72/AS01E was shown to provide approximately 50% protection against progression to active pulmonary TB over a three-year follow-up period in TB-infected HIV-negative adults aged 18 to 50 years. The World Health Organisation estimates a vaccine with this efficacy profile could prevent 76 million new TB cases, save 8.5 million lives, and save $41.5 billion for TB-affected households over 25 years. (ANI)

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