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Mundel is employed by the Gates Foundation. Pym is employed by Wellcome.
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Key takeaways:
- Wellcome and the Gates Foundation will supply up to $550 million for a phase 3 trial of a tuberculosis vaccine, M72.
- There has not been a new vaccine to prevent pulmonary TB in more than 100 years.
Wellcome and the Bill & Melinda Gates Foundation announced Wednesday that they will provide up to $550 million in funding for a phase 3 trial of a tuberculosis vaccine candidate.
The investigational vaccine, M72/AS01E, has been in development since the early 2000s. It was developed by GSK, which originally licensed the vaccine to the Gates Foundation in 2020. The vaccine continues to use GSK’s AS01 adjuvant system.
Data derived from the Gates Foundation, Wellcome
“Now that the COVID pandemic has settled into a more endemic state, TB is back again as the No. 1 infectious disease killer in the world,” Trevor Mundel, MD, PhD, president of global health at the Gates Foundation, said during a press briefing.
“Why do we need a vaccine? TB is an unusual bug that’s coevolved with humans for tens of thousands of years. We’ve made progress on diagnostics… and you might say, well, let’s test and let’s treat and that should take care of the problem. But because of that coevolution, TB has this propensity to persist in people, and these people can be infecting others in their community,” Mundel said.
M72 is one of 17 TB vaccine candidates currently in the pipeline, according to Wellcome. Previous studies have shown that it is nearly 50% effective in protecting infected adults from progression to pulmonary TB disease for at least 3 years and 54% effective after about 2 years in preventing active TB in HIV-negative adults with latent TB.
More than 140 years after the discovery of Mycobacterium tuberculosis, there is still only one licensed vaccine against TB, the bacille Calmette-Guérin (BCG) vaccine, which was first given to people in 1921.
Some countries use BCG to protect babies and young children against severe forms of TB. However, it offers limited protection against pulmonary TB among adolescents and adults, according to Wellcome. The vaccine is generally not recommended in the United States because of its limited effectiveness, the CDC noted.
The phase 3 trial, which will assess M72’s efficacy at preventing progression from latent TB to pulmonary TB, will enroll approximately 26,000 people — including people with HIV but not TB infection — at more than 50 sites in Africa and Southeast Asia.
Wellcome will provide up to $150 million in funding for the trial and the Gates Foundation will fund the remaining $400 million.
“A new TB vaccine would really be a game changer and essential for controlling TB. This is clearly a gap and we need to address it early and urgently,” Alexander Pym, MD, PhD, director of infectious disease at Wellcome, said during the briefing. “We believe, ultimately, that funding this trial is a real opportunity to have a very big impact on the millions of lines of people that are blighted around the world by TB.”
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