Gates Medical Research Institute, Serum Institute ink agreement to manufacture novel TB vaccine

The Gates Medical Research Institute (Gates MRI) and Serum Institute of India Private Ltd (SII) have agreed to manufacture M72/AS01E, a novel tuberculosis (TB) vaccine candidate. And SII expects to invest more than $100 million in strengthening its manufacturing readiness and capacity building to support potential future supply, they said in a joint communication.

The vaccine is undergoing Phase III clinical trial, and has the potential to be the first new TB vaccine to be introduced in more than a century, a joint communication said, on a disease that remains the world’s leading infectious cause of death that disproportionately impacts low- and middle-income countries.

This partnership ensures that the vaccine, if approved, 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,” the communication said.

Following the agreement, the process of transferring the technology and know-how required to manufacture the antigen and enable future large-scale production of M72/AS01E has begun, the note said, adding that GSK (GlaxoSmithKline), the original developer of the vaccine, will supply the AS01E adjuvant. “Initiating this work well ahead of Phase III 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,” the note said.

Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E, with funding from the Gates Foundation and Wellcome, the note said, adding that the double-blind, randomised trial, which started in March 2024 had reached full enrollment in April 2025 – with  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 percent 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 note said. The World Health Organization 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, it added.