Pune: Serum Institute of India (SII) and Gates Medical Research Institute (Gates MRI) have entered an agreement to manufacture M72/AS01E, a novel tuberculosis (TB) vaccine candidate.The clinical trial of the vaccine candidate is in Phase 3. M72/AS01E has the potential to be a new TB vaccine to be introduced in over a century.It could be a potential breakthrough against tuberculosis (TB), which remains the world’s leading single infectious disease killer. The World Health Organization (WHO) reports that 10.7 million people fall ill and 1.23 million die annually due to TB. About 25% of the global population is infected with TB bacteria, especially in low-and middle-income countries.The vaccine, if approved, can be produced at scale and made available to adults and adolescents in countries with a high TB burden as soon as possible, a statement issued by SII reads. SII’s record of producing WHO-prequalified vaccines, affordably and at scale and meeting stringent global quality and regulatory standards, pushed it for selection for the agreement. The two institutes also share the M72 partners’ commitment to global access and engaging local manufacturers in Indonesia and South Africa to support critical parts of the supply chain over time.With the 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. 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 the 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 is granted.Gates MRI has sponsored the Phase 3 trials of M72/AS01E with funding from the Gates Foundation and Wellcome. The double-blind, randomised trial, which started in March 2024, reached full enrolment in April 2025, with 20,000 participants from South Africa, Kenya, Malawi, Zambia and Indonesia across 54 sites.In a Phase 2b randomised, double-blind, placebo-controlled trial with 3,575 participants sponsored by the vaccine’s developer, GSK, the vaccine candidate was shown to provide 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.
