Gates MRI and Serum Institute partner to manufacture promising TB vaccine candidate
The Gates Medical Research Institute (Gates MRI) has entered into a partnership with the Serum Institute of India Private Limited (SII) to manufacture M72/AS01E, a novel tuberculosis (TB) vaccine candidate. This collaboration aims to enable large-scale production of the vaccine if it receives regulatory approval.
M72/AS01E is currently undergoing Phase 3 clinical trials. If successful, it would become the first new TB vaccine introduced in over a century. Tuberculosis remains the world's leading infectious cause of death, disproportionately affecting low- and middle-income countries, according to an official statement released on Thursday.
The partnership involves transferring technology and know-how required to manufacture the antigen and support future large-scale production. SII was selected based on its track record of producing World Health Organization (WHO)-prequalified vaccines affordably and at scale, while meeting stringent global quality and regulatory standards.
This step is critical to ensuring that, if approved, the vaccine can be quickly made available to adults and adolescents in countries with a high TB burden. The collaboration underscores ongoing efforts to combat a disease that killed an estimated 1.6 million people in 2021 alone, according to WHO data.
