Wellcome and the Bill & Melinda Gates Foundation have announced funding to advance tuberculosis vaccine candidate M72/AS01E (M72) through a Phase III clinical trial.

If proven effective, M72 could become the first vaccine to help prevent pulmonary TB, a form of active TB, in more than 100 years.

Wellcome and the Bill & Melinda Gates Foundation announced this at a virtual news conference on Wednesday.

The event featured Trevor Mundel, President of Global Health at the Gates Foundation; Alexander Pym, Director of Infectious Diseases at Wellcome; and Nomathamsanga Majozi, Head of Public Engagement at the Africa Health Research Institute.

The only TB vaccine in use today, Bacille Calmette-Guérin (BCG), was first given to people in 1921. It helps protect babies and young children against severe systemic forms of TB but offers limited protection against pulmonary TB among adolescents and adults.

TB is one of the world’s deadliest diseases, killing about 4,300 people per day, mostly those living in poverty. In 2021, an estimated 10.6 million people fell ill with TB, and 1.6 million died—about 4,300 people per day.

The disease primarily affects people in low and middle-income countries, and those at highest risk often live in poverty, with poor living and working conditions and undernutrition.

Up to a quarter of the world’s population is thought to have latent TB, a condition in which a person is infected with the bacterium that causes TB but does not have any symptoms and is at risk of progressing to active TB disease.

To support the M72 Phase III clinical trial, which will cost an estimated $550 million, Wellcome is providing up to $150 million, and the Gates Foundation will fund the remainder, about $400 million.

The vaccine, called M72, will be given in 2024 to 26,000 young adults in Africa and Southeast Asia with latent infection with the bacteria that cause TB but no symptoms.

Commenting on the efficacy, Trevor Mundel, the head of Global Health at the Bill & Melinda Gates Foundation, said that M72 had shown much promise in preventing TB in people with latent infections but were not ill.

He said this was an important segment of the population to target.

However, “clear evidence about M72’s efficacy in preventing the emergence of active pulmonary tuberculosis will take several years to emerge from trial.”

(NAN)