Tuberculosis Vaccine – Serum Institute Partners to Expand Production of Promising TB Shot
Tuberculosis Vaccine – Tuberculosis remains one of the world’s deadliest infectious diseases, and a major manufacturing partnership could accelerate access to a promising new vaccine if ongoing clinical trials prove successful.
Manufacturing Partnership Announced
The Gates Medical Research Institute (Gates MRI) has entered into a manufacturing agreement with Pune-based Serum Institute of India Private Limited (SII) for the production of M72/AS01E, an experimental tuberculosis vaccine currently undergoing Phase 3 clinical trials. The collaboration is designed to prepare large-scale manufacturing capabilities well before the vaccine completes regulatory review, allowing faster distribution if it receives approval.
According to the institute, the agreement is intended to ensure that adults and adolescents living in countries with a high burden of tuberculosis can gain timely access to the vaccine once it is authorized for public use.
Potential Milestone in Tuberculosis Prevention
If the vaccine successfully completes clinical testing and secures regulatory clearance, M72/AS01E could become the first new tuberculosis vaccine introduced in more than 100 years. Health experts consider this development significant because tuberculosis continues to be the leading infectious cause of death worldwide, particularly affecting low- and middle-income nations.
The World Health Organization’s Global Tuberculosis Report 2025 indicates that India was among eight countries responsible for 67% of the world’s reported TB cases in 2024, highlighting the need for improved prevention measures.
Why Serum Institute Was Selected
Gates MRI said Serum Institute was chosen because of its extensive experience in manufacturing vaccines that meet World Health Organization quality standards while maintaining affordability and large-scale production capacity. The institute has a long history of supplying vaccines globally and meeting strict international regulatory requirements.
The organization also noted that Serum Institute shares its commitment to expanding equitable access to vaccines. The long-term manufacturing strategy includes working with local production partners in Indonesia and South Africa to strengthen different parts of the global supply chain.
Technology Transfer and Investment Plans
As part of the agreement, Gates MRI will begin transferring the technology and manufacturing expertise needed for producing the vaccine’s antigen. This process is expected to help establish future large-scale production capabilities for M72/AS01E.
Serum Institute has announced plans to invest more than $100 million from its own resources to enhance manufacturing infrastructure and prepare facilities capable of supporting future global demand. Meanwhile, GSK, which originally developed the vaccine candidate, will continue supplying the AS01E adjuvant used in the formulation.
The organizations explained that beginning manufacturing preparations before Phase 3 trial results become available is intended to reduce delays between regulatory approval and public distribution if the vaccine proves successful.
Clinical Trial Progress
Gates MRI is sponsoring the ongoing Phase 3 clinical trial with financial support from the Gates Foundation and Wellcome. The double-blind, randomized study began in March 2024 and completed enrollment in April 2025, involving approximately 20,000 participants across 54 clinical sites located in South Africa, Kenya, Malawi, Zambia, and Indonesia.
The large-scale trial aims to evaluate the vaccine’s safety and effectiveness across diverse populations before any approval decisions are made.
Earlier Results Show Encouraging Findings
Previous clinical research has produced encouraging results for the vaccine candidate. In a Phase 2b randomized, double-blind, placebo-controlled study sponsored by GSK, involving 3,575 participants, M72/AS01E demonstrated about 50% effectiveness in preventing the progression from latent tuberculosis infection to active pulmonary TB over a three-year follow-up period.
The study focused on HIV-negative adults between the ages of 18 and 50 who were already infected with tuberculosis bacteria.
According to estimates from the World Health Organization, a vaccine with similar effectiveness could prevent nearly 76 million new tuberculosis cases over the next 25 years. It could also save an estimated 8.5 million lives while reducing the financial burden on affected households by approximately $41.5 billion during the same period.