A tuberculosis (TB) vaccine candidate in the late stage of development will get $550 million in funding from Wellcome and the Bill Melinda Gates Foundation.

The vaccine candidate M72 (M72/AS01E), could become the first in 100 years if proven effective.  

The Phase III clinical trial will start in early 2024 and be completed in about 4-6 years when the end-points of the study are reached, said Trevor Mundel, Gates Foundation’s President - Global Health. With an eye on the volumes that may be required, and the commitment to keep it affordable, he told media persons they were in discussion with multiple entities towards this purpose.

The study would cover 26,000 people across 50 sites across Africa and SE Asia, said Alexander Pym, Wellcome’s Director of Infectious Diseases, adding that it would be given to adolescents and adults. The trial sites were still being refined, he added.

About 20,000 of this group would have latent TB, 2000 would be those with HIV and the remaining 4,000 would be uninfected to get the safety profile across different groups, explained Trevor.

The M72 trial will cost an estimated $550 million, Wellcome is providing upto $150 million, while the Gates Foundation will fund the remaining about $400 million.

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

In the Phase IIb trial, M72 showed approximately 50 per cent  efficacy in reducing pulmonary TB in adults with latent TB infection, a joint note on the development said.

Contrast with Covid

TB is back to being the number one killer in the world in a post Covid-19 scenario, the experts said, calling for greater Government attention on the need for a vaccine. In 2021, an estimated 10.6 million people fell ill with TB and 1.6 million died, or about 4,300 people per day.

The stark contrast between Covid-19 and TB was that the Covid vaccine was developed rapidly, reflecting what can be achieved with political determination and funding, said Alex, calling for more of this for TB as well.

One in 17

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

The Gates Medical Research Institute holds the license for M72 in low- and middle-income countries with high TB burdens. M72 is  one of 17 TB vaccine candidates currently in the pipeline, and has been in development since the early 2000s.

It was developed by GSK up to the proof-of-concept phase (Phase IIb), along with Aeras and the International AIDS Vaccine Initiative (IAVI). The Gates Foundation partly funded it.

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