Wellcome and the Bill & Melinda Gates Foundation have announced funding totaling $550 million to advance a tuberculosis (TB) vaccine candidate through a Phase III clinical trial.

Funding includes up to $150 million from Wellcome and approximately $400 million from the Gates Foundation to assess the efficacy of M72/AS01E (M72) at preventing progression from latent TB infection to pulmonary TB. The M72 vaccine candidate, one of 17 TB vaccine candidates in the pipeline, has been in development since the early 2000s and, if proven effective, could become the first new vaccine to help prevent pulmonary TB in more than a century. The clinical trial will be sponsored by the Bill & Melinda Gates Medical Research Institute, a nonprofit subsidiary of the foundation.

According to the Gates Foundation, in 2021, an estimated 10.6 million people fell ill with TB and 1.6 million died—roughly 4,300 people per day. The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first administered to people in 1921, and while the vaccine helps protect babies and young children against severe systemic forms of the disease, it offers limited protection against pulmonary TB among adolescents and adults.

“With TB cases and deaths on the rise, the need for new tools has never been more urgent,” said Gates Foundation co-chair Bill Gates. “Greater investment in safe and effective TB vaccines alongside a suite of new diagnostics and treatments could transform TB care for millions of people, saving lives and lowering the burden of this devastating and costly disease.”

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