Gates Foundation, Wellcome Pledge $550M for Phase III Trial of GSK’s TB Vaccine

Pictured: Doctor injecting child with vaccine/Courtesy of iStock, Prostock-Studio

Pictured: Doctor injecting child with vaccine/Courtesy of iStock, Prostock-Studio

For the first time in over a century, the world could potentially see a new tuberculosis vaccine. The Bill & Melinda Gates Foundation and Wellcome announced Wednesday that they will fund an international clinical trial of an experimental TB vaccine candidate developed by GSK involving 26,000 people in Africa and Southeast Asia.

The charities are offering total funding of $550 million, with $150 million coming from the London-based Wellcome and the U.S.-based Gates Foundation providing the remaining $400 million.

M72/AS01E (M72), which GSK developed in partnership with Aeras and the International AIDS Vaccine Initiative, would be the first new vaccine to help prevent pulmonary TB in adolescents and adults. There is an existing vaccine, the bacille Calmette-Guérin (BCG) vaccine, which was first given to people in 1921. However, it is only effective when given to babies and young children.

The Bill & Melinda Gates Medical Research Institute, a subsidiary of the Gates Foundation, licensed the vaccine from GSK in 2020 for future use in low-income countries with a high TB burden.

Though the vaccine is only one of 17 candidates, it has demonstrated promising results, according to the Gates Foundation. In its Phase IIb trial, M72 “showed approximately 50% efficacy in reducing pulmonary TB in adults with latent TB infection,” the foundation said in a press release, calling it an “unprecedented result in decades of TB vaccine research.”

That could have global implications as the disease primarily affects people in lower and middle-income countries, according to the World Health Organization (WHO). A vaccine with that level of efficacy “could prevent up to 76 million new TB cases and 8.5 million deaths, avert the need for 42 million courses of antibiotic treatment and prevent US$41.5 billion in TB-related catastrophic household costs, especially for the world’s poorest and most vulnerable people,” WHO said in a recent report.

Despite being curable, TB remains one of the world’s deadliest diseases. According to another WHO report, an estimated 10.6 million people fell ill with TB in 2021, and 10% of them died: that’s about 1.6 million people, or 4,300 per day. As much as a quarter of the world’s population may have latent TB infection, which could develop into active TB.

The GSK vaccine is intended to prevent that progression, which is what the Phase III trial will be testing. The study will enroll over 26,000 people across 50 sites in Africa and Southeast Asia.

Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.

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