The Serum Institute of India has partnered with the Gates Medical Research Institute to manufacture the experimental tuberculosis vaccine candidate M72/AS01E, which could become the first new TB vaccine in over a century. Serum Institute of India plans to invest over $100 million to scale up production capacity. The vaccine, currently in Phase 3 trials, could prevent 76 million TB cases and save 8.5 million lives over 25 years if approved.
SII-Gates MRI manufacturing partnership
- ▪Serum Institute of India signed an agreement with the Gates Medical Research Institute to manufacture the experimental tuberculosis vaccine candidate M72/AS01E
- ▪Under the agreement, Gates Medical Research Institute will transfer the technology and know-how needed to manufacture the M72/AS01E vaccine antigen to Serum Institute of India
- ▪If approved, M72/AS01E is likely to be the first new tuberculosis vaccine introduced in more than 100 years
- ▪GSK, the original developer of the M72/AS01E vaccine candidate, will supply the AS01E adjuvant to boost the body's immune response
M72/AS01E Phase 3 trial
- ▪Gates Medical Research Institute is sponsoring the Phase 3 clinical trial of M72/AS01E with funding from the Gates Foundation and Wellcome
- ▪The Phase 3 trial of M72/AS01E reached full enrollment in April 2025 with 20,000 participants across 54 sites in South Africa, Kenya, Malawi, Zambia, and Indonesia
Phase 2b efficacy results
- ▪In a Phase 2b trial sponsored by GSK, M72/AS01E showed approximately 50% protection against active pulmonary tuberculosis over three years in HIV-negative adults aged 18 to 50
- ▪The Phase 2b trial of M72/AS01E was a randomized, double-blind, placebo-controlled study that enrolled 3,575 participants
TB vaccine impact projections
- ▪The World Health Organization estimates the vaccine could save $41.5 billion for tuberculosis-affected households over 25 years
- ▪The World Health Organization estimates a vaccine with M72/AS01E's efficacy profile could prevent 76 million new tuberculosis cases and save 8.5 million lives over 25 years
Manufacturing capacity investment
- ▪Serum Institute of India is initiating manufacturing readiness well ahead of Phase 3 trial results to ensure rapid distribution if the trial succeeds
- ▪Serum Institute of India plans to invest more than $100 million of its own resources to scale up manufacturing capacity and prepare for future vaccine supply
Story comments
Loading comments…