Manufacturer agreed for the M72/AS01E TB vaccine candidate, pending trial outcomes

The sponsor of the late-stage clinical trial Gates Medical Research Institute (Gates MRI) has reached an agreement with the Serum Institute of India Private Limited (SII) to manufacture M72/AS01E, a novel tuberculosis vaccine candidate. 

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. 

The WHO estimates that a vaccine with 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 – as was shown in M72/AS01E’s phase 2b trial – could prevent 76 million new TB cases, save 8.5 million lives, and save $41.5 billion for TB-affected households over 25 years. If successful, this vaccine could be a valuable addition to our toolkit to protect those at risk.  

The double-blind, randomised phase 3 clinical trial, funded by the Gates Foundation and Wellcome, began in March 2024. In April 2025, it reached full enrollment of 20,000 participants across 54 sites in South Africa, Kenya, Malawi, Zambia and Indonesia.  

Together 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.    

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 trial 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. 

This milestone underscores the importance of philanthropic investment in advancing promising TB innovations, but this support must be catalytic. Sustained, increased financing from the global community - across both public and private sectors - is essential to close the gap in TB research and development and ensure a robust pipeline of new vaccines and treatments reaches those who need them. 

For more information, please see the statement from Gates Medical Research Institute: https://www.gatesmri.org/gates-medical-research-institute-and-the-serum-institute-of-india-reach-agreement/