The Gates Medical Research Institute (Gates MRI) has formalised an agreement with the Serum Institute of India Private Limited (SII) to produce a novel tuberculosis (TB) vaccine candidate known as M72/AS01E. This vaccine is currently undergoing a Phase 3 clinical trial, with the potential to be the first new TB vaccine introduced in over a century. This initiative represents a significant advancement in combatting TB, which remains the leading infectious cause of death worldwide, particularly affecting low- and middle-income nations.

The collaboration is critical as it aims to ensure that, upon successful approval, the M72/AS01E vaccine can be manufactured at scale for distribution to adults and adolescents in countries with high rates of TB. SII was chosen due to its established track record in producing vaccines that are prequalified by the World Health Organization (WHO), adhering to stringent global quality and regulatory standards while maintaining affordability and production capacity.

A key aspect of this partnership is the mutual commitment to global access, which includes plans to engage local manufacturers in Indonesia and South Africa to support essential components of the supply chain over time.

Investment and Manufacturing Readiness

As part of this venture, Gates MRI and SII will initiate the transfer of technology and expertise required for the manufacturing of the vaccine antigen. SII anticipates investing over $100 million from its resources to enhance its manufacturing readiness and build capacity for potential future supply. This proactive approach is intended to facilitate immediate production and distribution of the vaccine should the Phase 3 trials yield positive results and requisite regulatory approvals are obtained.

GSK, the original developer of the vaccine, will provide the AS01E adjuvant, a crucial component for the vaccine’s efficacy. By beginning this process ahead of the Phase 3 trial results, both organisations aim to prepare for any surge in demand arising from the trial’s success.

Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E, which is funded by the Gates Foundation and Wellcome. This double-blind, randomised trial commenced in March 2024, reaching full enrollment by April 2025, with participation from 20,000 individuals across 54 sites in South Africa, Kenya, Malawi, Zambia, and Indonesia.

Potential Impact of the Vaccine

In a prior Phase 2b trial, also double-blind and involving randomisation, the M72/AS01E vaccine demonstrated approximately 50 per cent protection against the progression to active pulmonary TB during a three-year follow-up period. This trial included 3,575 participants who were TB-infected and HIV-negative, aged between 18 to 50 years, and was sponsored by GSK.

The World Health Organisation estimates that a vaccine with similar efficacy could avert 76 million new TB cases over a 25-year span. Furthermore, it could save approximately 8.5 million lives and relieve $41.5 billion in costs for households affected by TB. The implications of a successful TB vaccine are monumental, potentially altering the global landscape of tuberculosis treatment and prevention.

This cooperation between Gates MRI and SII sets the stage for significant advancements in TB management, reflecting an ongoing commitment to addressing one of the world’s most pressing health concerns.

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