Collaboration in Global Health Philanthropy Paves the Way for Funding the First New Tuberculosis Vaccine in a Century

Wellcome and the Bill & Melinda Gates Foundation have joined hands to provide funding for the final stage of trials for a potentially ground-breaking tuberculosis (TB) vaccine. With an investment of approximately $550 million, they aim to support the Phase III trials of the M72 vaccine, which could mark the first new vaccine against TB in over a century.

Despite being preventable and treatable, TB continues to affect 10 million individuals annually, leading to 1.6 million deaths in 2021, primarily in low and middle-income countries. TB has long held the position of the world’s deadliest infectious disease, although it was briefly overshadowed by the COVID-19 pandemic.

Bill Gates recently criticized the lack of funding for new tools against TB. His foundation will contribute the majority of the financing for the trial, amounting to around $400 million. However, the organization is also seeking commercial partners to facilitate large-scale production and delivery of the vaccine in the event of trial success.

Trevor Mundel, President of Global Health at the Gates Foundation, revealed that discussions are underway with potential vaccine manufacturers. He stated, “We have a couple of partners that are interested.” The trial, spanning 4-6 years, will involve over 26,000 participants across more than 50 sites in Africa and Southeast Asia. It will assess the vaccine’s effectiveness in preventing latent TB from progressing to active TB and causing illness, including among individuals with HIV.

The existing TB vaccine, Bacille Calmette-Guerin (BCG), has been administered since 1921 and offers limited protection against the lung-invading form of the disease in adolescents and adults. While it is effective in protecting infants and young children against severe TB, its efficacy diminishes over time.

The M72 vaccine, initially developed in the early 2000s by the Gates-backed non-profit Aeras and GSK, continues to utilize GSK’s adjuvant for immune enhancement. Recent Phase II trial data from 2018 demonstrated that the vaccine prevented TB development in approximately half of the recipients. Although the efficacy rate of 50% is relatively modest for vaccines, it has the potential to make a significant impact, potentially saving 8.5 million lives over 25 years, according to the World Health Organization.