Media365
India’s Serum Institute of India (SII) has joined the global race to develop and supply what could become the first new tuberculosis (TB) vaccine in more than 100 years, announcing a manufacturing partnership for an experimental vaccine candidate currently in late-stage clinical trials.
The Pune-based vaccine manufacturer said on Thursday it has entered into an agreement with the Gates Medical Research Institute (Gates MRI) to manufacture M72/AS01E, a novel TB vaccine candidate that has been under development for nearly two decades.
If approved, M72/AS01E could mark the first major advancement in TB vaccination since the Bacille Calmette-Guérin (BCG) vaccine, which remains the only widely used TB vaccine globally and was introduced more than a century ago.
Under the agreement, Serum Institute plans to invest more than $100 million to expand manufacturing capacity and prepare for potential future vaccine production and supply.
Serum Institute to scale up manufacturing
As part of the partnership, Gates MRI will transfer the technology and manufacturing expertise needed to produce the vaccine antigen, allowing Serum Institute to prepare for large-scale commercial manufacturing.
British pharmaceutical company GSK, which originally developed M72/AS01E, will continue to supply the AS01E adjuvant — a component designed to enhance the body’s immune response to the vaccine.
GSK had advanced the vaccine candidate through mid-stage clinical trials before licensing it to Gates MRI, which is now sponsoring its Phase 3 trial with support from the Bill & Melinda Gates Foundation and global health charity Wellcome.
Serum Institute said preparing manufacturing capacity ahead of regulatory approval would help ensure rapid production and distribution if the vaccine demonstrates efficacy and receives necessary approvals.
Why the TB vaccine breakthrough matters
Tuberculosis remains one of the biggest global health challenges, particularly in low- and middle-income countries.
According to the World Health Organization (WHO), TB is the world’s leading cause of death from a single infectious disease and remains among the top 10 causes of death globally.
Nearly 11 million people contracted tuberculosis in 2024, while about 1.23 million people died from the disease, WHO data showed.
India, Indonesia, the Philippines, China, Pakistan and Nigeria are among the countries with the highest TB burden.
Unlike COVID-19, where vaccines were developed within a year of the pandemic, TB vaccine development has been marked by decades of scientific challenges because of the complexity of the tuberculosis-causing bacteria.
A successful new vaccine could significantly reduce infections, deaths and healthcare costs in countries where TB continues to pose a major public health threat.
M72/AS01E shows promise in clinical trials
The M72/AS01E vaccine candidate has already shown encouraging results in earlier trials.
In a Phase 2b study involving 3,575 participants, the vaccine demonstrated around 50 per cent protection against progression to active pulmonary TB over a three-year follow-up period among TB-infected, HIV-negative adults aged 18 to 50 years.
The ongoing Phase 3 clinical trial, which began in March 2024, has enrolled around 20,000 participants across 54 sites in South Africa, Kenya, Malawi, Zambia and Indonesia.
The trial completed participant enrolment in April 2025 and will provide key data on the vaccine’s safety and effectiveness.
According to estimates shared by Serum Institute and Gates MRI, a vaccine with a similar efficacy profile could potentially prevent 76 million new TB cases, save 8.5 million lives, and generate economic savings of around $41.5 billion for TB-affected households over 25 years.
India strengthens role in global vaccine supply chain
The partnership reinforces India’s growing role in global vaccine manufacturing.
Serum Institute, one of the world’s largest vaccine producers, has played a major role in supplying affordable vaccines worldwide, including during the COVID-19 pandemic.
The company said it was selected for the partnership due to its ability to manufacture vaccines at scale while meeting international quality and regulatory standards.
Serum Institute also plans to work with manufacturers in countries such as Indonesia and South Africa to strengthen long-term supply chains and improve access to the vaccine in regions with high TB prevalence.
The push for new TB vaccines has gained global momentum. In 2023, WHO Director-General Tedros Adhanom Ghebreyesus established the TB Vaccine Accelerator Council to speed up the development, approval and deployment of new TB vaccines.
Other candidates are also advancing through clinical development, including Immuvac (MIP), developed by the Indian Council of Medical Research (ICMR) and Cadila Pharmaceuticals, and MTBVAC, developed by the University of Zaragoza and Biofabri in partnership with Hyderabad-based Bharat Biotech.
With multiple candidates moving through late-stage trials, the global race for a next-generation TB vaccine is entering a decisive phase — with India’s Serum Institute positioning itself at the centre of potential future supply.
