NEW DELHI: The Gates Medical Research Institute (Gates MRI) has signed an agreement with Pune-based Serum Institute of India Private Limited (SII) to manufacture M72/AS01E, a novel tuberculosis (TB) vaccine candidate.
Currently in a Phase 3 clinical trial, M72/AS01E has the potential to become the first new TB vaccine introduced in more than a century — a potential breakthrough against a disease that remains the world's leading infectious cause of death and disproportionately affects low- and middle-income countries.
"The 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," the company said in a statement.
India is among eight countries that accounted for 67% of global TB cases in 2024, according to the WHO Global Tuberculosis Report 2025.
The company said SII was selected for its proven track record of producing WHO-prequalified vaccines at scale and at affordable cost while meeting stringent global quality and regulatory standards.
It added that SII also shares the M72 partners' commitment to equitable global access and to engaging local manufacturers in Indonesia and South Africa to support key parts of the supply chain over time.
"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," the statement said.
SII expects to invest more than $100 million of its own resources to strengthen manufacturing readiness and build capacity to support potential future supply, it said.
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," the statement added.
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 began in March 2024, completed enrolment of 20,000 participants across 54 sites in South Africa, Kenya, Malawi, Zambia and Indonesia in April 2025.
In a Phase 2b randomised, double-blind, placebo-controlled trial involving 3,575 participants sponsored by GSK, M72/AS01E demonstrated around 50% protection against progression to active pulmonary TB over a three-year follow-up period among TB-infected, HIV-negative adults aged 18 to 50 years.
According to World Health Organization (WHO) estimates, a vaccine with this efficacy profile could prevent 76 million new TB cases, save 8.5 million lives and reduce costs for TB-affected households by $41.5 billion over 25 years, the statement added.