Serum, Gates MRI join hands for TB vaccine

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, 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. ...