The Gates Medical Research Institute and the Serum Institute of India have reached an agreement to manufacture M72/AS01E, a novel tuberculosis (TB) vaccine candidate, pending successful Phase III trial outcomes. If approved, M72/AS01E could become the first new TB vaccine introduced in over a century and represent a significant breakthrough against this disease, the company said.
The Serum Institute plans to invest more than $100 million of its own resources to enhance manufacturing readiness and capacity to support potential future supply. The Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E, with funding provided by the Gates Foundation and Wellcome.
This partnership is a step toward ensuring that, if the vaccine is approved, it can be produced on a large scale and made available to adults and adolescents in countries with a high burden of TB as soon as possible. Tuberculosis remains the world’s leading infectious cause of death, disproportionately affecting low- and middle-income countries.
SII was chosen due to its strong track record of producing WHO-prequalified vaccines affordably and at scale while meeting stringent global quality and regulatory standards. Gates MRI and SII will begin the process of transferring the necessary technology and expertise required for manufacturing the antigen, enabling future large-scale production of M72/AS01E. GSK, the original developer of the vaccine, will supply the AS01E adjuvant.
In a Phase 2b randomised, double-blind, placebo-controlled trial involving 3,575 participants, sponsored by the vaccine’s developer GSK, M72/AS01E demonstrated approximately 50% efficacy in protecting against the progression to active pulmonary TB over a three-year follow-up period among HIV-negative adults aged 18 to 50.
The World Health Organisation estimates that a vaccine with this level of efficacy could prevent 76 million new TB cases, save 8.5 million lives, and save $41.5 billion for households affected by TB over a span of 25 years.
