Kallenberg, J., et al. Preparing for Tuberculosis Vaccine M72/AS01E Implementation: A Global Demand Forecast and Key Influential Factors. Infect Dis Ther, 2026 Feb 25, PMID: 41739348
This paper provides a comprehensive, data-driven forecast of global demand for the novel M72/AS01E tuberculosis vaccine, which has the potential to significantly reduce TB-related mortality worldwide. Given TB’s status as one of the deadliest infectious diseases, particularly affecting adolescents and adults, understanding future vaccine demand is essential for ensuring adequate manufacturing capacity, strategic planning, and timely access. The study considers various factors, including epidemiological burden, funding scenarios, policy implementation, and country-specific adoption timelines, to inform stakeholders and facilitate coordinated efforts toward equitable vaccine delivery, ultimately aiming to accelerate progress toward TB elimination.
The study forecasts that, under the base-case scenario, global demand for the M72/AS01E TB vaccine will reach approximately 56 million doses annually by 2036, with demand peaking in this period and then declining following the introduction of an additional TB vaccine assumed in 2037. Demand is driven mainly by routine vaccination of adolescents and at-risk groups, with substantial contributions from high-burden countries such as India, Indonesia, and Pakistan. Key messages include the importance of early, coordinated planning among stakeholders to ensure timely vaccine access, as demand could vary significantly, by up to 43% in upside scenarios or decrease by 34% in downside scenarios, depending on efficacy, funding, and policy timing. The findings emphasize that proactive policy, manufacturing readiness, and collaborative efforts are critical to maximizing the vaccine’s impact in reducing TB burden worldwide.
The document discusses the AS01 E adjuvant extensively. It highlights that AS01 E is a component of the M72/AS01E vaccine, manufactured by GSK, and emphasizes its role in the vaccine formulation. The text covers aspects such as the manufacturing process, the importance of ensuring sufficient supply for global demand, and the relevance of AS01 E in the context of vaccine development and deployment. Additionally, the experience with the RTS,S/AS01 malaria vaccine, which also utilizes AS01, is used as a case study to illustrate regulatory approval processes, policy recommendations, and factors influencing vaccine adoption.
Comment from DKI: Demand forecasting plays a critical role in informing supply planning and accelerating access. As the world’s leading supplier of purified saponin fractions, including QS-21, Desert King International is well-positioned to support the projected global demand associated with M72/AS01E and other AS01-containing vaccines. With vertically integrated operations and control of the supply chain from sustainable raw material sourcing to GMP-grade QS-21 production, DKI has the capacity and manufacturing readiness to reliably supply the forecasted volumes. We are prepared to scale in alignment with global demand scenarios and to collaborate with partners to ensure that adjuvant supply does not become a bottleneck in accelerating access to life-saving TB vaccines.
Link: https://pubmed.ncbi.nlm.nih.gov/41739348/
