The novel vaccine candidate, M72/AS01E, has been in development for two decades and is currently in a late-stage clinical trial.
Serum Institute plans to invest more than $100 million to scale up manufacturing capacity and prepare for future vaccine supply, pending approval, the company said.
Under the agreement, Gates MRI, founded by the Gates Foundation, will transfer the technology and know-how needed to manufacture the vaccine antigen and enable large-scale production, Serum Institute said.
GSK, which originally developed the vaccine candidate, will supply the AS01E adjuvant, an ingredient used to boost the body’s immune response.
GSK advanced the vaccine through mid-stage testing before licensing it to Gates MRI, which is sponsoring the late-stage trial with support from the Gates Foundation and Wellcome, a major London-based charity.
Tuberculosis is the world’s leading cause of death from a single infectious agent and is among the top 10 causes of death, the WHO said in a report last year.Nearly 11 million people contracted tuberculosis in 2024, while 1.23 million died from the disease, according to the WHO’s data.
India, Indonesia, the Philippines, China, Pakistan and Nigeria are among the countries bearing the highest burden of tuberculosis, the WHO said.
“The World Health Organization estimates a vaccine with this efficacy profile could prevent 76 million new TB cases, save 8.5 million lives, and save $41.5 billion for TB-affected households over 25 years,” Serum and Gates MRI said.
The Bacille Calmette-Guerin (BCG) vaccine is currently the only widely used vaccine against tuberculosis.