India's Serum Institute partners with Gates MRI to make experimental TB vaccine

India's Serum Institute partners with Gates MRI to make experimental TB vaccine

The Serum Institute of India Private Limited (SII) has signed a landmark agreement with the Gates Medical Research Institute (Gates MRI) to manufacture M72/AS01E, an experimental tuberculosis vaccine candidate. If approved, it would represent the first new TB shot introduced in more than 100 years.

The vaccine candidate has been in development for two decades. It is currently undergoing final Phase 3 clinical trials. To ensure that production and distribution can begin without delay if the vaccine demonstrates efficacy and secures regulatory approvals, SII plans to invest more than $100 million of its own resources to expand production capacity and strengthen manufacturing readiness.

Under the terms of the partnership, Gates MRI, which was founded by the Gates Foundation, will transfer the technology and know-how necessary to manufacture the vaccine antigen. However, GlaxoSmithKline (GSK) will continue to supply the proprietary AS01E adjuvant, an ingredient used to boost the immune response. GSK originally developed the candidate and advanced it through mid-stage testing before licensing it to Gates MRI.

Clinical Trial Progress

The Phase 3 trial is being sponsored by Gates MRI with funding from Wellcome, a London-based charity, and the Gates Foundation. The trial began in March 2024 and completed enrolment in April 2025. It is a randomised, double-blind study involving 20,000 participants across 54 sites in Indonesia, Zambia, Malawi, Kenya, and South Africa.

Previous data from a Phase 2b study sponsored by GSK provided a baseline for the current efforts. That trial included 3,575 HIV-negative adults aged 18 to 50 who were TB-infected. Over a three-year follow-up period, M72/AS01E demonstrated approximately 50% protection against progression to active pulmonary TB.

The World Health Organization (WHO) has estimated that a vaccine with this efficacy profile could save 8.5 million lives and prevent 76 million new TB cases over 25 years. Such a result would also save TB-affected households $41.5 billion during that period.

The Global Burden of Tuberculosis

Tuberculosis remains among the top 10 causes of death globally and is the leading cause of death from a single infectious agent, according to a WHO report from last year. The disease disproportionately affects low- and middle-income countries. WHO data indicates that 1.23 million people died from the disease in 2024, while nearly 11 million people contracted tuberculosis.

Countries bearing the highest burden include Nigeria, Pakistan, China, the Philippines, Indonesia, and India. Currently, the Bacille Calmette-Guérin (BCG) vaccine is the only widely used shot against the disease.

Because of its record in producing affordable WHO-prequalified vaccines that meet international regulatory and quality standards, SII was selected as the partner for this project. The company plans to work with local manufacturers in South Africa and Indonesia to strengthen the long-term supply chain and ensure equitable global access for adolescents and adults in high-burden regions.

Broader Vaccine Efforts

The push for new vaccines has gained momentum since 2023, when the WHO Director-General established the TB Vaccine Accelerator Council to speed up deployment by using lessons learned from the COVID-19 pandemic.

Other candidates are also moving through late-stage development:

• Immuvac (MIP): Developed by Cadila Pharmaceuticals and the Indian Council of Medical Research (ICMR), this candidate is currently in Phase 3 trials.
• MTBVAC: A live-attenuated vaccine derived from a human Mycobacterium tuberculosis strain. Developed by Biofabri and the University of Zaragoza and advanced with Bharat Biotech, it is undergoing Phase 3 efficacy trials in newborns in TB-endemic countries, alongside Phase 2 and Phase 2b studies in adults and adolescents.