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New TB Vaccine Nears Finish Line
16 Jul
Summary
- A novel TB vaccine candidate, M72/AS01E, is in a Phase 3 clinical trial.
- The Serum Institute of India is partnering to manufacture the vaccine at scale.
- The vaccine candidate has shown approximately 50% protection in prior trials.
A significant advancement in the fight against tuberculosis is underway as the M72/AS01E vaccine candidate progresses through a Phase 3 clinical trial. The Gates Medical Research Institute has joined forces with the Serum Institute of India (SII) for potential large-scale manufacturing.
This partnership is a crucial step towards ensuring the vaccine, which could be the first new one in over a century, is readily available. SII's proven record in producing WHO-prequalified vaccines affordably and at scale makes it an ideal partner. SII is set to invest over US$100 million to bolster manufacturing capabilities.
The Phase 3 trial, sponsored by Gates MRI with funding from the Gates Foundation and Wellcome, enrolled 20,000 participants across South Africa, Kenya, Malawi, Zambia, and Indonesia in April 2025. Earlier Phase 2b trial results showed M72/AS01E provided around 50% protection against active pulmonary TB in adults. The World Health Organization estimates such efficacy could prevent millions of cases and save millions of lives globally.
