Serum Institute, Gates MRI partner to manufacture landmark TB vaccine

PUNE, INDIA — In a historic development for global public health, the Serum Institute of India (SII) has officially entered into a definitive manufacturing agreement with the Bill & Melinda Gates Medical Research Institute (Gates MRI) to produce the M72/AS01E tuberculosis vaccine candidate at a global scale. Under the landmark pact, announced on July 16, 2026, the world’s largest vaccine manufacturer by volume will invest more than $100 million of its own corporate resources to ready its advanced facilities in Pune, India, for commercial production.

The alliance, which includes multinational pharmaceutical giant GSK as a core partner, aims to build an immediate commercial launchpad for what could become the first new tuberculosis (TB) vaccine introduced to the world in more than a century.

Addressing a Century-Old Gap in Global Immunization

Tuberculosis remains the world's deadliest infectious disease, claiming approximately 1.2 million lives annually, with the vast majority of cases and deaths occurring in low- and middle-income countries (LMICs). Currently, the only widely available vaccine is Bacillus Calmette-Guérin (BCG), which was developed in 1921. While BCG is effective in protecting infants against severe, disseminated forms of the disease, its protective window wanes significantly over time, leaving adolescents and adults highly vulnerable to active pulmonary TB.

The M72/AS01E tuberculosis vaccine candidate is designed to fill this critical gap. Originally developed through Phase II clinical trials by GSK in partnership with the non-profit Aeras, the investigational subunit vaccine is engineered to protect adolescents and adults. It consists of the M72 recombinant fusion protein combined with GSK's proprietary AS01E adjuvant system.

Phase IIb clinical data previously demonstrated that the vaccine successfully achieved roughly 50% efficacy in preventing active pulmonary TB among individuals with latent tuberculosis infections, meeting the World Health Organization's (WHO) preferred product criteria.

A Tripartite Alliance for Scaled Manufacturing

The freshly inked agreement creates a robust supply chain architecture by linking philanthropic, scientific, and industrial powerhouses:

• Gates Medical Research Institute: Acts as the clinical sponsor and lead developer, currently managing a massive Phase III registration trial across 60 sites in Africa and Asia (including South Africa, Kenya, Zambia, Malawi, and Indonesia).

• Serum Institute of India: Assumes the role of the primary commercial manufacturing partner, leveraging its immense industrial capacity to produce the final vaccine vials at an affordable cost for LMICs.

• GSK: Continues to play an active role in future access planning and commits to supplying its proprietary AS01E adjuvant. This ingredient is highly complex to manufacture, as it relies on QS-21, a scarce natural extract from the soapbark tree (Quillaja saponaria).

The $100 million capital expenditure pledge by SII will be utilized to establish dedicated, high-speed formulation, filling, and packaging lines in Pune. This proactive investment ensures that the moment Phase III clinical trials yield positive safety and efficacy data, mass production can begin without administrative or operational bottlenecks.

Impact on High-Burden Nations and Global Healthcare

A successful rollout of the M72/AS01E tuberculosis vaccine candidate would drastically reshape public health economics. Because TB disproportionately affects working-age individuals, active infections impose a massive financial burden on families, businesses, and national healthcare budgets.

Epidemiological modeling suggests that introducing a vaccine with 50% efficacy in a high-burden country like India could prevent millions of active cases and hundreds of thousands of deaths over the next two decades, alleviating pressure on municipal clinics and reducing the spread of multi-drug resistant TB (MDR-TB).

Official Sources Section

The details of this collaboration, including the corporate commitments and vaccine mechanics, were officially confirmed in joint statements released by GSK plc, the Bill & Melinda Gates Medical Research Institute, and corporate filings from the Serum Institute of India.

Quote Section

Leaders from across the participating organizations expressed intense optimism regarding the industrial transition of the project:

"By joining forces with SII, this milestone marks an important step from innovation toward impact. Together, this is bringing us closer to our aim of potentially helping prevent active pulmonary TB in adolescents and adults."

— Dr. Harmony P. Garges, Chief Global Health Officer, GSK

Why It Matters

For over a century, the fight against TB has relied on a single, aging infant vaccine. This partnership represents the first time a globally verified, highly effective adult and adolescent TB candidate has been paired with a manufacturing engine capable of churning out hundreds of millions of low-cost doses. Practically, it means that if the ongoing Phase III trials succeed, high-burden nations will have direct, affordable, and rapid access to a life-saving tool, bypassing the decade-long supply delays that historically plague newly launched vaccines in developing economies.

Key Facts at a Glance

• Historic Partnership: SII has signed an agreement with Gates MRI to manufacture the M72/AS01E tuberculosis vaccine candidate.

• Massive Capital Pledge: SII will invest over $100 million of its own funds in Pune to prepare manufacturing facilities for rapid, large-scale production.

• Sustained Efficacy: Phase IIb trials showed approximately 50% efficacy in preventing active pulmonary TB in adults over three years.

• Adjuvant Supply secured: GSK will act as the exclusive supplier of the critical, highly complex AS01E adjuvant.

• Trial Phase: The vaccine is currently undergoing a massive Phase III trial involving approximately 20,000 participants in Africa and Asia.

FAQ Section

Why is the M72/AS01E vaccine considered such a breakthrough?

It is the first vaccine candidate in over 100 years that has shown significant, positive efficacy in protecting adults and adolescents against active pulmonary tuberculosis, a major limitation of the traditional BCG vaccine.

What role does GSK play if Gates MRI and SII are handling the trials and manufacturing?

GSK originally developed the vaccine and holds the rights to the proprietary AS01E adjuvant system. Under this deal, GSK remains an active partner and commits to supplying this essential adjuvant to the Serum Institute for final vaccine blending.

When will the vaccine be commercially available?

The vaccine is currently in Phase III trials, which are expected to collect safety and efficacy data through 2028. If the outcomes are successful and receive swift regulatory approvals, commercial production and distribution will commence shortly after.

Source: Official media releases from GSK plc, programmatic updates from the Gates Medical Research Institute, and corporate profile portfolios of the Serum Institute of India.