IAVI is pleased that Wellcome and the Bill & Melinda Gates Foundation have announced their plans to fund the Bill & Melinda Gates Medical Research Institute to conduct a Phase III clinical trial of the tuberculosis (TB) vaccine candidate M72/AS01E (M72) in adults. IAVI and Aeras, a nonprofit whose assets were acquired by IAVI in 2018, along with GSK and other partners, conducted a successful Phase IIb trial of M72. Results were published in 2019 showing that vaccination with M72 had an acceptable safety profile and led to a significantly reduced incidence of pulmonary TB disease in HIV-negative adults with latent TB infection. We are gratified that this promising vaccine candidate is progressing to the next stage of development.
IAVI urges funders, especially from the public sector, to commit additional resources for TB vaccine R&D, building on the excitement and energy generated by the Wellcome/Gates Foundation announcement and the September 2023 United Nations High-Level Meeting on Tuberculosis. The only available TB vaccine, BCG, is more than 100 years old. It offers some protection to young children but has limited effectiveness at preventing pulmonary TB in adults and adolescents, who are mainly responsible for spreading TB. As we saw with COVID-19, it is essential that multiple vaccines be advanced into efficacy trials and that many vaccines are available so that people of all ages and in all geographies may benefit from them.
Spanish biopharmaceutical company Biofabri, a subsidiary of ZENDAL, and IAVI announced their agreement in May 2023 to collaborate on end-to-end development of the TB vaccine candidate MTBVAC. Biofabri launched a Phase III trial of MTBVAC in neonates in late 2022 with support from the European & Developing Countries Clinical Trials Partnership. IAVI plans an efficacy trial of MTBVAC in adults and adolescents to begin in 2024 after securing sufficient funding. We hope to make further announcements about this program soon.
Since the COVID-19 emergency has ended, TB is on track once again to be the deadliest infectious disease in the world, killing an estimated 1.6 million people in 2021, about 14% of whom were children. New vaccines to prevent TB disease in infants, adolescents, and adults are needed more urgently than ever.