Serum Institute of India to Manufacture Experimental TB Vaccine M72/AS01E in Partnership with Gates Medical Research Institute

Jul 16, 2026

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.