Serum Institute of India (SII) has entered into an agreement with the Gates Medical Research Institute (Gates MRI) to develop manufacturing capabilities for the investigational M72/AS01E tuberculosis (TB) vaccine candidate, marking another major global vaccine partnership for the Pune-based company as it expands beyond routine immunisation into next-generation infectious disease programmes.
Under the agreement, SII will manufacture and supply the vaccine candidate for countries with a high TB burden, subject to the successful completion of ongoing Phase III clinical trials and regulatory approvals.
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The partnership is intended to ensure that, if approved, the vaccine can be produced at scale and supplied at an affordable price to low- and middle-income countries, where TB remains a leading cause of death.
The M72/AS01E vaccine candidate is being developed by Gates MRI after it licensed the asset from GSK.
It is among the most advanced TB vaccine candidates globally and, if successful, could become the first new vaccine to prevent pulmonary tuberculosis in adults in over a century, complementing the century-old BCG vaccine.
For SII, the agreement builds on a series of global partnerships announced this month, reflecting its strategy of expanding into vaccines and biologics targeting diseases with a high public health burden.
Earlier this week, the company announced the launch of the world’s first Phase I clinical trial for a Bundibugyo ebolavirus vaccine candidate, being developed by the University of Oxford’s Jenner Institute and Oxford Vaccine Group. Separately, it said Brazil, Malaysia and Thailand would participate in a global clinical trial evaluating a dengue therapeutic developed by SII.
The latest agreement also reinforces SII’s position as a manufacturing partner for global health organisations seeking large-scale, low-cost vaccine production. The company, the world’s largest vaccine manufacturer by volume, already supplies vaccines to more than 170 countries and has played a key role in global immunisation programmes.
Tuberculosis continues to cause more than one million deaths annually worldwide despite being both preventable and treatable, underscoring the need for more effective vaccines for adolescents and adults.
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