Gates MRI has chosen Serum Institute of India to manufacture the investigational TB vaccine M72/AS01E, now in Phase 3 trials. The partnership establishes early production capacity for rapid global access if efficacy and safety are confirmed.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
The Gates Medical Research Institute (Gates MRI) has selected the Serum Institute of India Private Limited (SII) as the manufacturing partner for M72/AS01E, an investigational tuberculosis (TB) vaccine currently being evaluated in a global Phase 3 clinical trial. The agreement establishes manufacturing capacity well before regulatory review, enabling rapid production and distribution if the vaccine demonstrates efficacy and safety in the ongoing study.
Under the agreement, SII will manufacture the M72 antigen component of the vaccine, while GSK will continue supplying the proprietary AS01E adjuvant under a separate arrangement. Gates MRI and SII will begin technology transfer and manufacturing readiness activities immediately. SII plans to invest more than US$100 million to expand production capabilities and prepare for large-scale supply.
Scientific and Clinical Context
Tuberculosis remains the world’s leading infectious cause of death, with an estimated 10.7 million people developing active disease and 1.23 million deaths reported in 2024. The disease disproportionately affects low- and middle-income countries, where delayed diagnosis, poverty, and limited healthcare access continue to drive transmission.
The Bacille Calmette-Guérin (BCG) vaccine has been used for more than a century but primarily protects infants and young children against severe forms of TB. Its protection against pulmonary tuberculosis in adolescents and adults is limited, highlighting the need for new preventive vaccines.
M72/AS01E combines the M72 recombinant antigen with GSK’s AS01E adjuvant system to stimulate immune responses against Mycobacterium tuberculosis. The vaccine is intended to prevent latent TB infection from progressing to active pulmonary disease, the form responsible for most transmission.
Phase 3 Trial and Earlier Clinical Evidence
Gates MRI is sponsoring the ongoing double-blind, randomized, placebo-controlled Phase 3 trial with funding from the Gates Foundation and Wellcome. The study enrolled approximately 20,000 adolescents and adults aged 15 to 44 years across 54 clinical sites in South Africa, Kenya, Malawi, Zambia, and Indonesia. Enrollment was completed in April 2025 after the trial began in March 2024, and participants will be followed for up to four years to determine whether vaccination prevents progression to active TB disease.
The Phase 3 program builds on encouraging Phase 2b findings (NCT01755598) generated by GSK. In that randomized, double-blind, placebo-controlled study involving 3,575 Mycobacterium tuberculosis-infected, HIV-negative adults aged 18 to 50 years, M72/AS01E demonstrated approximately 50% protection against progression to active pulmonary TB over three years. Earlier Phase 1 and Phase 2 studies also supported a clinically acceptable safety profile, while additional studies (NCT04556981) in people living with HIV showed the vaccine was well tolerated and generated immune responses.
According to World Health Organization estimates cited by Gates MRI, a vaccine with similar efficacy could prevent 76 million new TB cases, save 8.5 million lives, and reduce household economic losses by approximately US$41.5 billion over 25 years.
Clinical Perspective
The manufacturing partnership reflects a strategic decision to establish production capacity before clinical results become available. Gates MRI noted that technology transfer and vaccine manufacturing require significant time, making early investment essential to reduce the interval between potential regulatory approval and real-world access.
SII was selected based on its experience producing WHO-prequalified vaccines at global scale and its ability to meet international manufacturing and regulatory standards. The partners also plan to engage manufacturers in Indonesia and South Africa over time to strengthen regional supply chains and improve long-term vaccine availability in high-burden countries.
Path Forward
Results from the Phase 3 trial are expected in late 2028. If the vaccine demonstrates favorable efficacy and safety, global and national regulatory submissions are anticipated to begin in 2029. The collaboration also supports long-term planning for affordable and sustainable vaccine access across low- and middle-income countries with a high tuberculosis burden.
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About the Writer
Dr.Preethi Putti, PharmD (LinkedIn) is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.
