Wellcome and the Bill & Melinda Gates Foundation have partnered to fund a Phase III clinical trial of a tuberculosis (TB) vaccine candidate, M72/AS01E. This vaccine, if proven effective, could become the first new vaccine in over 100 years to help prevent pulmonary TB. The announcement was made during a virtual news conference, featuring prominent figures from both organizations.
TB is one of the deadliest diseases globally, responsible for thousands of deaths each day, particularly among those living in poverty. The current TB vaccine, Bacille Calmette-Guérin (BCG), has been in use since 1921, offering limited protection against pulmonary TB among adults and adolescents.
The M72/AS01E vaccine, which will be given to 26,000 young adults in Africa and Southeast Asia from 2024, aims to protect individuals with latent TB infections, who are at risk of developing active TB disease. The Phase III clinical trial is estimated to cost around $550 million, with Wellcome contributing up to $150 million and the Gates Foundation funding the remainder.
Trevor Mundel, the Head of Global Health at the Gates Foundation, expressed optimism about the vaccine’s potential in preventing TB in individuals with latent infections. While it will take several years to obtain clear evidence of its efficacy in preventing active pulmonary tuberculosis, an efficacy rate of at least 50% is deemed satisfactory based on current modeling.
Making the vaccine as affordable and accessible as possible is a key concern. Julia Gillard, Chair of the Board of Governors at Wellcome, emphasized that philanthropy can play a pivotal role in driving progress and turning the tide against TB. She emphasized the need for global collaboration, financial support, and political will to ensure sustainable progress in tackling TB and other infectious diseases.
According to Alexander Pym, the Director of Infectious Disease at Wellcome, TB is one of the biggest health challenges worldwide. The complex nature of the human immune response to TB and the threat of latent TB make the development of a TB vaccine a lengthy process. Pym stressed the need for new approaches and tools to address this urgent challenge.
Bill Gates, Co-chair of the Bill & Melinda Gates Foundation, highlighted the increasing need for new tools to combat TB as cases and deaths continue to rise. He emphasized the importance of investing in safe and effective TB vaccines, along with improved diagnostics and treatments, to transform TB care and reduce the burden of this devastating disease.
Dr. Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization (WHO), commended the Gates Foundation and Wellcome for their support in developing a new TB vaccine. The WHO will continue to support vaccine development and access through its TB Vaccine Accelerator Council.
This partnership and the funding provided by Wellcome and the Gates Foundation offer new hope for a TB-free future. As TB remains a significant threat to global health, advancements in vaccine development and access are crucial in combating this deadly disease.
