Preparing for Tuberculosis Vaccine M72/AS01E Implementation: A Global Demand Forecast and Key Influential Factors

Abstract Introduction Tuberculosis (TB) affects over 10 million people worldwide annually, is difficult to treat, and is a major cause of death. The M72/AS01E candidate vaccine is the first vaccine in over 100 years with the potential to protect adolescents/adults. To prepare for the introduction of the vaccine and ensure adequate manufacturing capacity, global vaccine demand must be carefully estimated in advance. Methods A global demand forecasting model was developed that considered demand factors such as TB burden, external funding, anticipated interest, and country vaccine adoption capabilities, which determined assumptions for the timing and implementation approach of vaccine introduction. Assuming initial M72/AS01E regulatory approval in 2029, demand for routine vaccination and catch-up campaigns was forecasted through to 2045. Results Adoption of M72/AS01E was projected to begin in South Africa in 2029, expanding to 89 countries by 2039. In the base-case forecast, demand reached a steady state of around 56 million doses per year by 2036, and decreased to around 43 million doses per year following licensure of another global TB vaccine, assumed in 2037. Seven countries accounted for 61% of demand, and approximately half of all demand was from Gavi-eligible countries (Gavi, the Vaccine Alliance). In scenario analyses, demand increased by 43% (peaking at 79 million in 2036), assuming higher efficacy and more available funding, and decreased by 34%, assuming narrower, delayed policy recommendations and less available funding. Key drivers of global demand included adoption timing, target population, and coverage. Conclusions M72/AS01E has the potential to reduce the TB burden worldwide. Successful vaccine introduction requires early and coordinated planning, with detailed demand forecasting refined over time. The model will be updated as new data and country implementation plans emerge. To avoid access delays, continued collaboration among key stakeholders, including vaccine suppliers, and early visibility on policy recommendations and domestic and donor funding availability will be critical in the coming years.