India Steps into a Historic Global Health Mission
India has strengthened its position at the forefront of global vaccine innovation with the Serum Institute of India (SII) securing manufacturing rights for M72/AS01E, a promising late-stage tuberculosis (TB) vaccine candidate being developed in partnership with the Gates Medical Research Institute (Gates MRI). If successful, the vaccine could become the first new TB vaccine introduced in more than a century, marking a transformative milestone in the fight against one of the world's deadliest infectious diseases. The agreement also underscores India's growing role not only as the "pharmacy of the world" but as a critical partner in delivering next-generation vaccines to millions across low- and middle-income countries.
A Century-Long Search for a Better TB Vaccine
Tuberculosis continues to be the world's leading killer caused by a single infectious agent despite the widespread use of the Bacille Calmette-Guérin (BCG) vaccine. Although BCG has been instrumental in protecting young children against severe forms of TB, its effectiveness against adult pulmonary tuberculosis—the most common and infectious form of the disease—has remained inconsistent and limited.
To address this long-standing gap, pharmaceutical company GSK spent more than two decades developing the M72/AS01E vaccine candidate. It combines the M72 fusion protein, derived from two Mycobacterium tuberculosis antigens, with the AS01E adjuvant system that has already demonstrated success in malaria and shingles vaccines. Unlike BCG, which primarily protects children, M72/AS01E is specifically designed to prevent latent TB infections from progressing to active disease among adolescents and adults, representing an entirely new immunological strategy.
Serum Institute Becomes the Manufacturing Backbone
On July 16, 2026, Gates MRI and the Serum Institute of India announced a landmark manufacturing partnership. Under the agreement, SII will produce the M72 antigen, while GSK will continue supplying the proprietary AS01E adjuvant through a separate arrangement. The collaboration also includes a comprehensive transfer of technology and manufacturing expertise from Gates MRI to SII.
To support future commercial production, the Serum Institute plans to invest over US$100 million in dedicated manufacturing facilities. As the world's largest vaccine producer by volume, SII is expected to become the principal manufacturing hub for supplying the vaccine to countries with a high TB burden, should regulatory approvals follow successful clinical trials.
Clinical Progress and Global Significance
M72/AS01E is currently undergoing a large Phase III clinical trial involving nearly 20,000 participants, with enrolment completed ahead of schedule. Earlier Phase IIb studies demonstrated encouraging efficacy in preventing the progression from latent TB infection to active disease among adults, paving the way for late-stage clinical evaluation.
The vaccine's development has been supported by Gates MRI, the Gates Foundation and Wellcome after GSK advanced the candidate through mid-stage trials before transferring its further development. If Phase III findings confirm both safety and effectiveness, M72/AS01E would become the first novel TB vaccine in over 100 years and the first specifically developed for adolescents and adults—a breakthrough that could fundamentally reshape global tuberculosis prevention strategies.
A Strategic Milestone for India and Global Health
For India, becoming the manufacturing base for one of the world's most anticipated vaccines carries significance far beyond industrial capacity. As the country continues to bear one of the highest TB burdens globally, the partnership aligns national public health priorities with its expanding leadership in affordable vaccine manufacturing.
The collaboration also reflects a new global innovation model, bringing together advanced scientific research, philanthropic investment and large-scale manufacturing capabilities to accelerate equitable access. By combining Gates MRI's clinical stewardship, GSK's proven adjuvant technology and Serum Institute's production expertise, the initiative seeks to bridge scientific discovery with global public health delivery.
A Defining Opportunity in the Fight Against Tuberculosis
The Serum Institute's entry into the M72/AS01E programme represents far more than a manufacturing agreement—it symbolizes India's growing influence in shaping the future of global healthcare innovation. If the vaccine fulfils its promise, it could close a century-old gap in tuberculosis prevention while demonstrating how emerging-market manufacturers can play a pivotal role in delivering cutting-edge biomedical technologies at scale. Beyond advancing science, this partnership has the potential to save millions of lives and redefine the global battle against one of humanity's oldest infectious diseases.
(With agency inputs)
