• Say TB one of world’s deadliest disease, killing about 4,300 people daily

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

The organisations said the late-stage development of a Tuberculosis Vaccine Candidate could be the first in 100 years if proven effective.
Under the M72 Phase III clinical trial, which will cost an estimated US$550 million, Wellcome is providing up to US$150 million and the Gates Foundation will fund the remainder, about US$400 million.

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

The foundation noted that in 2021, an estimated 10.6 million people fell ill with TB while 1.6 million representing 4,300 people died each day as a result of the disease.

According to the BMGF, the disease primarily affects people in low- and middle-income countries, and those at highest risk are often living in poverty, with poor living and working conditions and under-nutrition.

Co-chair of the BMGF, Bill Gates said that 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.

He explained that with TB cases and deaths on the rise, the need for new tools has never been more urgent stressing that 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.”

Over 25 years, a vaccine with at least 50% efficacy could prevent up to 76 million new TB cases and 8.5 million deaths, avert the need for 42 million courses of antibiotic treatment, and prevent US$41.5 billion in TB-related catastrophic household costs, especially for the world’s poorest and most vulnerable people, according to the World Health Organization (WHO).

Commenting on the TB situation, the Head of Public Engagement at Africa Health Research Institute, Nomathamsanqa Majozi, observed that despite being curable, TB remains one of the leading causes of death in South Africa.

Majozi noted that 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.

She said, “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.”

In her submission, chair of the Board of Governors at Wellcome, Julia Gillard, stated that TB remains one of the world’s deadliest infectious diseases adding that the development of an affordable, accessible vaccine for adults and adolescents would be game-changing in turning the tide against TB.

She said, “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.”

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.”