India’s Serum Institute partners with Gates MRI to make experimental TB vaccine

(Reuters) - Serum Institute of India said on Thursday it would manufacture an experimental tuberculosis vaccine under an ​agreement with the Gates Medical Research Institute, in what is ‌likely to be the first new TB shot in more than 100 years if approved.

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 (GSK.L), opens new tab, 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-Guérin (BCG) vaccine is currently the only widely used ​vaccine against tuberculosis.