Gates MRI, Serum Institute of India sign agreement to manufacture Tuberculosis Vaccine candidate
Pune, July 16
The Gates Medical Research Institute on Thursday signed an agreement with the Serum Institute of India Private Limited to manufacture a novel tuberculosis vaccine candidate M72/AS01E.
Currently in a Phase 3 clinical trial, M72/AS01E has the potential to be the first new TB vaccine to be introduced in more than a century - a potential breakthrough against a disease that remains the world's leading infectious cause of death and disproportionately impacts low- and middle-income countries.
This partnership marks a critical step toward ensuring that, if approved, the vaccine can be produced at scale and made available to adults and adolescents in countries with a high TB burden as soon as possible.
SII was selected based on its strong track record of producing WHO-prequalified vaccines, affordably and at scale, and meeting stringent global quality and regulatory standards. They also share the M72 partners' commitment to global access and to engaging local manufacturers in Indonesia and South Africa to support critical parts of the supply chain over time.
With this partnership, Gates MRI and SII will begin the process of transferring the technology and know-how required to manufacture the antigen and enable future large-scale production of M72/AS01E.
SII expects to invest more than US$100 million of its own resources to strengthen manufacturing readiness and capacity building to support potential future supply. GSK, the original developer of the vaccine, will supply the AS01E adjuvant.
Initiating this work well ahead of Phase 3 trial results is a deliberate strategy to ensure readiness to produce and distribute the vaccine and begin meeting global demand as quickly as possible, should the trial be successful and regulatory approvals be granted.
Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E, with funding from the Gates Foundation and Wellcome. The double-blind, randomised trial, which started in March 2024, reached full enrollment in April 2025 of 20,000 participants in South Africa, Kenya, Malawi, Zambia, and Indonesia across 54 sites.
In a Phase 2b randomised, double-blind, placebo-controlled trial with 3,575 participants sponsored by the vaccine's developer, GSK, M72/AS01E was shown to provide approximately 50% protection against progression to active pulmonary TB over a three-year follow-up period in TB-infected HIV-negative adults aged 18 to 50 years.
The World Health Organisation estimates a vaccine with this efficacy profile could prevent 76 million new TB cases, save 8.5 million lives, and save $41.5 billion for TB-affected households over 25 years.
— ANI
Reader Comments
Finally some good news for TB control! I work in public health and we see so many drug-resistant TB cases. A new vaccine after 100 years could be a game-changer. But I hope the price remains affordable for Indian patients - that's the real test for Serum Institute.
Impressive that SII is investing $100 million of their own money. They've proven with COVID vaccines that they can deliver at massive scale. Let's hope this partnership works out as well.
Great initiative but I have one concern - why are the trials being done only in Africa and Indonesia? India has one of the highest TB burdens globally. Shouldn't we be included in Phase 3 trials to ensure it works for our population? Genuinely asking because different genetic backgrounds can affect vaccine efficacy.
It's quite a big deal that SII is also involving local manufacturers in Indonesia and South Africa. This isn't just about making vaccines - it's about building manufacturing capacity in the Global South. TB is a disease of poverty and this approach makes perfect sense.
The numbers from WHO are staggering - 76 million cases prevented and 8.5 million lives saved over 25 years! Even a 50% efficacy vaccine can have enormous impact. This is what global health partnerships should look like.
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