Serum Institute, Gates Medical Research Institute partners to manufacture new TB vaccine

In a major boost to India’s vaccine manufacturing capabilities and the global fight against tuberculosis (TB), Pune-based Serum Institute of India Private Limited (SII) is set to become the first manufacturer of a new TB vaccine that could be introduced in more than a century.

The Gates Medical Research Institute (Gates MRI) has signed a landmark agreement with SII to manufacture M72/AS01E, a novel tuberculosis vaccine candidate currently undergoing final Phase 3 clinical trials. As part of the partnership, SII plans to invest more than US$100 million of its own resources to strengthen manufacturing readiness and expand production capacity in anticipation of future global demand.

Tuberculosis remains the world’s deadliest infectious disease, disproportionately affecting low- and middle-income countries. Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E with funding from the Gates Foundation and Wellcome. The trial, which began in March 2024, completed enrolment in April 2025, with 20,000 participants recruited across 54 sites in South Africa, Kenya, Malawi, Zambia and Indonesia.

The vaccine candidate has already shown encouraging results. In a Phase 2b study involving 3,575 participants and sponsored by its original developer, GSK, M72/AS01E demonstrated 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.

According to the World Health Organisation (WHO), a vaccine with this efficacy profile could prevent 76 million new TB cases, save 8.5 million lives, and reduce the economic burden on TB-affected households by US$41.5 billion over the next 25 years.

Under the new agreement, Gates MRI and SII will begin transferring the technology and manufacturing know-how required to produce the vaccine antigen, paving the way for large-scale commercial production if the vaccine receives regulatory approval. GSK will continue to supply the proprietary AS01E adjuvant, a key component of the vaccine.

If successful, M72/AS01E could be rapidly manufactured at scale and made available to adults and adolescents in countries with a high TB burden.

SII, one of the world’s largest vaccine manufacturers, was selected for the partnership because of its proven ability to produce WHO-prequalified vaccines at affordable prices while meeting stringent international quality and regulatory standards. The company also shares the partners’ commitment to ensuring equitable global access and plans to work with local manufacturers in Indonesia and South Africa to strengthen the long-term supply chain.

SII said initiating manufacturing preparations well before the completion of Phase 3 trials is a deliberate strategy designed to ensure production and distribution can begin as quickly as possible if the vaccine demonstrates efficacy and secures regulatory approvals.

The urgency for new TB vaccines has gained global recognition. In 2023, the WHO Director-General established the TB Vaccine Accelerator Council to speed up the development, evaluation, approval and deployment of new TB vaccines by applying lessons learned during the COVID-19 pandemic.

Several other TB vaccine candidates are also advancing through late-stage clinical development. Among them is Immuvac (MIP) for tuberculosis and immunomodulation, developed by the Indian Council of Medical Research (ICMR) and Cadila Pharmaceuticals, which is also currently in Phase 3 trials.

Another promising candidate is MTBVAC, the first live-attenuated TB vaccine derived from a human Mycobacterium tuberculosis strain. Developed by the University of Zaragoza and Biofabri, and being advanced in partnership with Hyderabad-based Bharat Biotech, MTBVAC is undergoing Phase 3 efficacy trials in newborns in TB-endemic countries, alongside Phase 2b and Phase 2 studies in adolescents and adults.