GSK-developed TB vaccine candidate progresses toward global access with new manufacturing agreement

For media and investors only

16 July 2026

GSK welcomes the agreement reached between the Gates Medical Research Institute and Serum Institute of India (SII) for the manufacture of the M72/AS01_E tuberculosis vaccine candidate, pending successful Phase 3 trial outcomes.

M72/AS01_E is a novel tuberculosis (TB) vaccine candidate originally identified and developed through to Phase 2 trials by GSK. It was licensed to Gates MRI in 2020, with GSK still playing an active role in future access planning and as the adjuvant supplier.

The agreement between Gates MRI and SII also commits GSK, as the adjuvant innovator, to a manufacturing partner for M72/ AS01_E, and marks a critical step toward ensuring that, if approved, the vaccine can be produced at scale and made available to those who need it most.

Dr. Harmony P. Garges, Chief Global Health Officer, GSK, said “Every year, more than 1.2 million people die of TB – the world’s deadliest infectious disease.¹ 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. Together, this is bringing us closer to our aim of potentially helping prevent active pulmonary TB in adolescents and adults.”

The vaccine candidate is currently in a Phase 3 trial sponsored by Gates MRI with funding from the Gates Foundation and Wellcome. If approved, it has the potential to be the first TB vaccine introduced in more than a hundred years – and the first ever specifically for adolescents and adults.

TB places a significant economic burden on individuals, families and economies. If approved, making M72/AS01_E, 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.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025, and GSK’s Q1 Results for 2026.