Preparing for Tuberculosis Vaccine M72/AS01_E Implementation: A Global Demand Forecast and Key Influential Factors

Area of Science:

• * Global health and infectious disease research.
• * Vaccine development and implementation science.

Background:

• * Tuberculosis (TB) remains a significant global health challenge, affecting millions annually and causing substantial mortality.
• * The M72/AS01E candidate vaccine represents a novel approach to TB prevention in adolescents and adults, marking a significant advancement after a century without new TB vaccines.

Purpose of the Study:

• * To estimate global demand for the M72/AS01E TB vaccine to ensure manufacturing capacity.
• * To forecast vaccine demand through 2045, considering various adoption scenarios and influencing factors.

Main Methods:

• * Development of a global demand forecasting model incorporating TB burden, funding, and country-specific adoption capabilities.
• * Assumptions included M72/AS01E regulatory approval in 2029, with forecasts covering routine vaccination and catch-up campaigns.

Main Results:

• * Projected demand reaching a steady state of approximately 56 million doses annually by 2036, with a decrease to 43 million after a second TB vaccine launch in 2037.
• * Seven countries and Gavi-eligible nations are identified as major demand centers, accounting for 61% and 50% of demand, respectively.
• * Scenario analyses indicated potential demand fluctuations of +43% to -34% based on efficacy, funding, and policy recommendations.

Conclusions:

• * The M72/AS01E vaccine holds significant promise for reducing the global TB burden.
• * Successful introduction necessitates proactive planning, accurate demand forecasting, and stakeholder collaboration.
• * Continuous model refinement and early visibility on funding and policy are crucial to prevent access delays.