CAMBRIDGE, MA / PUNE: In a major boost to global tuberculosis control efforts, the Bill & Melinda Gates Medical Research Institute (Gates MRI) and Serum Institute of India Private Limited (SII) have reached an agreement for the large-scale manufacture of the investigational M72/AS01E tuberculosis (TB) vaccine candidate. The partnership aims to ensure rapid and affordable access to the vaccine in high-burden countries, including India, if it proves safe and effective in ongoing Phase 3 trials.
The agreement, announced on July 16, 2026, positions Serum Institute of India — the world’s largest vaccine manufacturer by volume — as the primary manufacturer of the M72 antigen component of the vaccine. Gates MRI will continue to sponsor and lead the clinical development program, while GSK will supply the AS01E adjuvant. Under the terms of the deal, SII will receive technology transfer and know-how to enable large-scale production. The Pune-based company has committed to investing over US$100 million of its own resources to build manufacturing readiness and expand capacity.
The M72/AS01E vaccine candidate is currently in a large-scale Phase 3 clinical trial. The double-blind, randomized, placebo-controlled study, which began in March 2024, has already achieved full enrollment of approximately 20,000 participants across 54 sites in five countries — South Africa, Kenya, Malawi, Zambia, and Indonesia. The trial is evaluating the vaccine’s ability to prevent pulmonary TB in adolescents and adults, including those living with HIV. Earlier Phase 2b results showed that the vaccine reduced the risk of progression to active pulmonary TB by approximately 50% over three years in HIV-negative adults with latent TB infection.
India stands to benefit significantly from this development. The country continues to bear one of the world’s highest burdens of tuberculosis, with millions of new cases reported annually. A new vaccine that protects adolescents and adults — the age groups responsible for most transmission — could complement the existing BCG vaccine given to infants and help reduce the overall incidence of TB, including drug-resistant forms. Successful integration of M72/AS01E into India’s national immunization program could lead to substantial reductions in morbidity, mortality, and economic losses caused by the disease.
Globally, the implications are even more far-reaching. According to modeling by the World Health Organization, a vaccine with the efficacy profile demonstrated in Phase 2b trials could prevent an estimated 76 million new TB cases and save 8.5 million lives over 25 years. It could also generate economic savings of approximately US$41.5 billion for TB-affected households by reducing the catastrophic costs associated with the disease. The partnership between Gates MRI and SII is specifically designed to ensure that, if approved, the vaccine can be produced at scale and made available at an affordable price in low- and middle-income countries where the need is greatest.
SII was chosen for this critical role due to its proven track record of producing high-quality, WHO-prequalified vaccines at affordable prices and at massive scale. The company has committed to working with local manufacturers in countries such as Indonesia and South Africa to further strengthen regional supply chains. Work on technology transfer and manufacturing scale-up has already begun, well ahead of the expected Phase 3 results, to minimize delays in access should the vaccine receive regulatory approval.
This agreement marks a significant step toward addressing one of the world’s oldest and deadliest infectious diseases. While the final efficacy and safety data from the Phase 3 trial are still awaited, the collaboration between Gates MRI and Serum Institute of India reflects a strong commitment to ensuring that any successful new TB vaccine reaches those who need it most — quickly, affordably, and at the required scale. If successful, M72/AS01E could become the first new TB vaccine in more than 100 years and a powerful new tool in the global fight to end tuberculosis.
