India’s Serum Institute announced Thursday that it will produce an experimental tuberculosis vaccine through a new partnership with the Gates Medical Research Institute — a move that could result in the first new TB vaccine in more than 100 years, if the shot receives approval.
The vaccine candidate, known as M72/AS01E, has been in development for roughly 20 years and is currently undergoing a late-stage clinical trial to test its effectiveness.
Serum Institute said it plans to pour more than $100 million into expanding its manufacturing capabilities to prepare for large-scale vaccine production, contingent on regulatory approval.
As part of the agreement, Gates MRI — which was founded by the Gates Foundation — will hand over the technology and expertise required to produce the vaccine’s key ingredient, enabling mass production, according to Serum Institute.
GSK, the company that originally developed the vaccine candidate, will provide the AS01E adjuvant, a component designed to strengthen the body’s immune response to the vaccine.
GSK had previously advanced the vaccine through mid-level testing before licensing it to Gates MRI. Gates MRI is now overseeing the late-stage trial with financial backing from the Gates Foundation and Wellcome, a major London-based charitable organization.
Tuberculosis remains one of the world’s deadliest diseases. According to a recent World Health Organization report, it is the leading cause of death from a single infectious agent and ranks among the top 10 overall causes of death globally.
WHO data shows that nearly 11 million people were infected with tuberculosis in 2024, and approximately 1.23 million people died from the disease that year.
Countries carrying the heaviest tuberculosis burden include India, Indonesia, the Philippines, China, Pakistan, and Nigeria, according to the WHO.
In a joint statement, Serum Institute and Gates MRI noted that “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.”
Currently, the only widely available vaccine against tuberculosis is the Bacille Calmette-Guérin, or BCG, vaccine.
