The Gates Foundation and Wellcome Join Forces to Fund Late-Stage Tuberculosis Vaccine

Wellcome and the Bill & Melinda Gates Foundation have announced a combined $550 million funding initiative to accelerate the progress of tuberculosis (TB) vaccine candidate M72/AS01E (M72), through its Phase III clinical trial. The initiative aims to combat the devastating impact of TB, which claims the lives of approximately 4,300 individuals per day, primarily those living in poverty. The success of M72 could mark the first significant advancement in TB prevention in over a century.

TB remains a major global health concern, affecting an estimated 10.6 million people worldwide in 2021, with 1.6 million losing their lives to the disease. The majority of cases occur in low- and middle-income countries, where impoverished living conditions, inadequate nutrition, and poor healthcare infrastructure contribute to the high burden. Up to a quarter of the global population carries the TB bacterium without symptoms, posing a significant risk for the progression of active TB disease.

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M72: a Promising Vaccine Candidate for Tuberculosis Prevention

According to the Gates Foundation’s press release, the promising vaccine candidate for TB prevention contains the M72 recombinant fusion protein, which is derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the GSK proprietary Adjuvant System AS01E. A Phase III clinical trial for M72 will be supported by a fund estimated to cost around US$550 million. Wellcome will provide up to US$150 million, with the Gates Foundation funding the remaining US$400 million. Julia Gillard, chair of the Board of Governors at Wellcome, acknowledges the critical need for progress, emphasizing the potential impact of an affordable and accessible TB vaccine for adults and adolescents.

The only available TB vaccine, Bacille Calmette-Guérin (BCG), was first administered to people in 1921. It primarily protects infants and young children against severe systemic forms of TB, offering limited efficacy against pulmonary TB in older individuals. Bill Gates, co-chair of the Bill & Melinda Gates Foundation, emphasizes the urgency for investment in new tools to combat TB, recognizing the need for safe and effective TB vaccines alongside improved diagnostics and treatments.

The Potential Impact of a Successful Vaccine

A successful vaccine for TB could have a significant impact. The World Health Organization (WHO) predicts that over 2025-2050, a vaccine with at least 50% could prevent an estimated 76 million new TB cases and save 8.5 million lives. It could also eliminate the need for 42 million courses of antibiotic treatment and reduce TB-related household costs by approximately US$41.5 billion, benefiting the most vulnerable populations.

The Phase III clinical trial for M72 will assess its efficacy in preventing the progression from latent TB infection to pulmonary TB. The trial aims to enroll approximately 26,000 participants, including individuals living with HIV, across more than 50 trial sites in Africa and Southeast Asia. The Bill & Melinda Gates Medical Research Institute (Gates MRI), a nonprofit subsidiary of the Gates Foundation dedicated to developing and implementing biomedical interventions for global health challenges, will sponsor the trial.

In addressing the TB crisis, WHO Director-General Tedros Adhanom Ghebreyesus emphasized that the Gates Foundation and Wellcome Foundation have provided support to the development of a new vaccine, as well as the opportunity provided by the UN high-level meeting in September, shows that sustained political and financial action can turn the tide. “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.”

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GeneOnline Team