The Serum Institute of India (SII) has partnered with the Gates Medical Research Institute (Gates MRI) to manufacture and help develop an experimental tuberculosis (TB) vaccine, a move that could strengthen global efforts to combat one of the world’s deadliest infectious diseases. The collaboration brings together one of the world’s largest vaccine manufacturers and a leading medical research organisation to accelerate the development of a vaccine that could offer better protection against tuberculosis in adolescents and adults.
The partnership centres on M72/AS01E, an experimental TB vaccine candidate that has delivered encouraging results in earlier clinical trials. If ongoing studies are successful and regulatory approvals are secured, it could become the first new vaccine in more than a century designed to prevent tuberculosis in adults, marking a major breakthrough in global healthcare.
Tuberculosis continues to pose a significant public health challenge despite being preventable and curable. According to the World Health Organization (WHO), the disease remains one of the leading infectious killers worldwide. India carries the highest TB burden globally, making the development of an effective vaccine particularly important for the country’s public health goals.
Under the collaboration, the Serum Institute of India will manufacture the vaccine for late-stage clinical trials and prepare for large-scale production if the vaccine receives regulatory approval. With decades of experience in supplying vaccines worldwide, SII is expected to play a key role in ensuring the vaccine reaches countries where tuberculosis remains a major health concern.
The M72/AS01E vaccine has already shown promising results in a Phase 2b clinical trial. Researchers found that it significantly reduced the risk of active pulmonary tuberculosis among adults with latent TB infection, giving scientists hope that it could become an effective tool in controlling the disease.
The vaccine is now moving into larger Phase 3 clinical trials, which will evaluate its safety and effectiveness across different populations and countries with a high incidence of tuberculosis. These studies are considered the final major step before regulators decide whether the vaccine can be approved for public use.
Health experts say the partnership comes at a crucial time. While the century-old BCG vaccine provides protection against severe TB in children, it offers limited effectiveness against pulmonary tuberculosis in adolescents and adults, who account for most disease transmission. An effective adult vaccine could therefore play a transformative role in reducing infections and preventing deaths.
The collaboration also reflects the growing importance of partnerships between research organisations and vaccine manufacturers. Gates MRI brings scientific expertise and clinical research capabilities, while Serum Institute contributes large-scale manufacturing experience and global distribution networks.
For the Pune-based Serum Institute, the agreement further strengthens its role in addressing major global health challenges. The company has supplied billions of vaccine doses worldwide and became internationally recognised for manufacturing COVID-19 vaccines during the pandemic. The new partnership expands its contribution to tackling infectious diseases that continue to affect millions of people.
India has intensified its efforts to eliminate tuberculosis through early diagnosis, improved treatment programmes and public awareness campaigns. However, experts believe vaccination remains one of the most effective long-term strategies to reduce new infections and lower the disease burden.
If approved, the M72/AS01E TB vaccine could complement existing prevention programmes and significantly improve protection among adults, particularly in countries with high TB prevalence. Wider vaccine coverage could also reduce transmission, easing pressure on healthcare systems.
Although the vaccine is still undergoing clinical evaluation, researchers remain optimistic about its potential. The collaboration between Serum Institute of India and Gates Medical Research Institute demonstrates how global partnerships can accelerate medical innovation while improving access to life-saving vaccines.
For millions of people at risk of tuberculosis, the partnership represents more than scientific progress. It offers hope that a disease responsible for countless deaths every year may finally have a stronger defence through a modern, effective vaccine.
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