GSK's M72/AS01E Tuberculosis Vaccine Candidate Advances Toward Global Access with Serum Institute of India Manufacturing Agreement
核心洞察
Gates MRI and Serum Institute of India reach agreement to manufacture the M72/AS01E TB vaccine candidate, pending Phase 3 trial outcomes.
The vaccine could be the first new TB vaccine in over a century and the first ever specifically for adolescents and adults.
Phase 3 trial enrolled 20,000 participants across 54 sites in five countries, with results expected to determine regulatory pathway.
Gates Medical Research Institute (搜索) (Gates MRI) has reached an agreement with the Serum Institute of India Private Limited (SII) to manufacture M72/AS01E, a novel tuberculosis (搜索) vaccine candidate originally developed by GSK, marking a critical step toward ensuring global access should the ongoing Phase 3 trial prove successful.
The agreement, announced on 16 July 2026, also commits GSK as the adjuvant innovator and supplier of the AS01E (搜索) adjuvant component. 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.
"Every year, more than 1.2 million people die of TB – the world's deadliest infectious disease," said Dr. Harmony P. Garges, Chief Global Health Officer at GSK. "I am deeply proud of our more than 20 years of investment in science and innovation behind the development of this vaccine and our ongoing collaboration with Gates MRI. By joining forces with SII, this milestone marks an important step from innovation toward impact."
A potential first in over a century
M72/AS01E has the potential to be the first new TB vaccine introduced in more than a hundred years – and the first ever specifically for adolescents and adults. The vaccine candidate was originally identified and developed through to Phase 2 trials by GSK and was licensed to Gates MRI in 2020, with GSK continuing to play an active role in future access planning.
The World Health Organization 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 demonstrated in M72'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.
Phase 3 trial design and status
The double-blind, randomised Phase 3 clinical trial, funded by the Gates Foundation and Wellcome, began in March 2024 and reached full enrollment of 20,000 participants across 54 sites in South Africa, Kenya, Malawi, Zambia, and Indonesia in April 2025. The trial is sponsored by Gates MRI.
Initiating manufacturing preparations well ahead of Phase 3 trial results represents a deliberate strategy to ensure readiness to produce and distribute the vaccine as quickly as possible, should the trial be successful and regulatory approvals be granted.
Manufacturing and access strategy
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 was selected based on its strong track record of producing WHO-prequalified vaccines affordably and at scale, while meeting stringent global quality and regulatory standards.
The partners share a commitment to global access and to engaging local manufacturers in Indonesia and South Africa to support critical parts of the supply chain over time. If approved, making M72/AS01E available and affordable in high-burden countries most affected by TB is a priority for all partners to help reduce the global burden of this disease.
This milestone underscores the importance of philanthropic investment in advancing promising TB innovations. However, 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.