Wellcome and the Bill & Melinda Gates Foundation have announced funding for the advancement of a tuberculosis (TB) vaccine candidate called M72/AS01E (M72) through a Phase III clinical trial.
The Phase III clinical trial for M72, which is estimated to cost around $550 million, will be funded by Wellcome (up to $150 million) and the Gates Foundation (around $400 million).
If successful, M72 could potentially become the first new vaccine to prevent pulmonary TB, a form of active TB, in over 100 years.
“Despite being curable, TB remains one of the leading causes of death in South Africa,” said Nomathamsanqa Majozi, head of public engagement at Africa Health Research Institute. “In the area where I live and work, more than half of all people have had, or will have, TB at some point in their lives. The consequences are devastating, both at a personal and a community level. M72 offers us new hope for a TB-free future.”
TB remains a significant global health challenge, with an estimated 10.6 million people falling ill with TB and 1.6 million deaths occurring in 2021.
The disease primarily affects individuals in low- and middle-income countries, particularly those living in poverty with poor living conditions and undernutrition. Latent TB, where individuals are infected with the TB bacterium but show no symptoms, affects up to a quarter of the world’s population and poses a risk of developing active TB disease.
“The development of an affordable, accessible vaccine for adults and adolescents would be game-changing in turning the tide against TB. Philanthropy can be a catalyst to drive progress, as shown by this funding of the M72 vaccine as a potential new tool in preventing escalating infectious diseases to protect those most affected. Sustainable progress against TB and wider disease threats will depend on global collaboration, financial backing, and political will. By working with communities and researchers in countries with a high burden of the disease, we can get one step closer to eliminating TB as a public health threat,”said Julia Gillard, chair of the Board of Governors at Wellcome.
The trial aims to assess the vaccine candidate’s efficacy in preventing the progression from latent TB infection to pulmonary TB. It will involve approximately 26,000 participants, including individuals living with HIV and those without TB infection, across more than 50 trial sites in Africa and Southeast Asia.
The M72 vaccine candidate, one of 17 TB vaccine candidates in development, has shown promising results in reducing pulmonary TB in adults with latent TB infection during Phase IIb trials.
The vaccine was developed by GSK in collaboration with Aeras and the International AIDS Vaccine Initiative (IAVI) and received funding support from the Gates Foundation. GSK has partnered with the Bill & Melinda Gates Medical Research Institute (Gates MRI) to further develop and potentially deploy the M72 vaccine in countries with a high TB burden.
The development of an effective and affordable TB vaccine for adults and adolescents would be a significant advancement in combating TB.
A vaccine with at least 50% efficacy could potentially prevent millions of new TB cases, save lives, reduce the need for antibiotic treatment, and alleviate the financial burden associated with the disease.
The funding provided by Wellcome and the Gates Foundation for the M72 Phase III clinical trial reflects the need for sustained political and financial action to address the TB crisis.
“With TB cases and deaths on the rise, the need for new tools has never been more urgent,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. “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.”
The World Health Organization (WHO) has welcomed the commitments and emphasizes the importance of developing a new vaccine to reduce disease transmission and prevent avoidable deaths, particularly among adults and adolescents who bear the majority of the TB burden.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus said the support by the Gates Foundation and Wellcome to develop a new TB vaccine, and the opportunity of September’s UN high-level meeting on TB, shows the world can turn the tide on the TB crisis through sustained political and financial action.
“The tuberculosis crisis demands a new vaccine to reduce disease transmission and avoidable death, especially targeting adults and adolescents who carry at least 90% of the TB epidemic’s burden,” said Dr. Tedros. “WHO welcomes the commitments from the Bill & Melinda Gates Foundation and Wellcome to take forward development of this vaccine candidate, and WHO will keep supporting vaccine development and access more broadly through its TB Vaccine Accelerator Council.”
TB remains a pressing global health issue, and the development of new tools such as vaccines, along with improved diagnostics and treatments, is crucial in the fight against this devastating and costly disease.
TB is also the leading killer of people living with HIV, accounting for one-third of deaths among HIV- positive people. The world’s most vulnerable populations are disproportionately affected by TB, with many cases of TB occurring in resource-limited areas. Over 80% of cases and deaths are in low- and middle-income countries.
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