GSK TB vaccine candidate secures manufacturing for global access
GSK plc has welcomed a manufacturing agreement between Gates MRI and Serum Institute of India for its M72/AS01E tuberculosis vaccine candidate. The deal aims to ensure large-scale production if the vaccine is approved.
GSK plc announced its support for a manufacturing agreement between the Gates Medical Research Institute (Gates MRI) and the Serum Institute of India (SII) concerning the M72/AS01E tuberculosis vaccine candidate. This agreement is contingent upon the successful outcome of Phase 3 trials.
The M72/AS01E is a novel TB vaccine candidate that GSK originally developed through to Phase 2 trials. The company licensed the vaccine to Gates MRI in 2020 for further development. GSK continues to play an active role in planning for future access and will supply the adjuvant.
This new agreement with SII designates GSK as the adjuvant innovator and manufacturing partner for M72/AS01E. It represents a critical step towards ensuring that, upon approval, the vaccine can be produced at scale and made available to those most in need.
Globally, tuberculosis claims over 1.2 million lives annually, making it the deadliest infectious disease. GSK has invested over two decades in the science and innovation behind this vaccine. The collaboration with Gates MRI, and now SII, signifies a crucial step from innovation toward impact.