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Supporting countries with prioritization of new vaccine introductions (NVI) and portfolio optimization

Support countries with using multi-criteria decision analysis (MCDA) for prioritization of new vaccine introductions (NVI) (including new TB vaccines) and portfolio optimization, embedded in the NIS development process. The project's key questions are: 1. How can we best support countries with NVI including new TB vaccine prioritization regarding access to evidence, tools, technical support? 2. What criteria do countries use when prioritizing NVIs? 3. How to best align NVI prioritization with the NIS development process.

Facing up to reality? What to do if M72/AS01E doses are limited

The Ph3 trial for the vaccine candidate M72/AS01E is underway, and, assuming a positive result, could be licensed by 2030. Modelling suggested a large potential impact from introducing M72/AS01E but assumed an unconstrained dose supply. However, at least initially, it is likely that M72/AS01E will be supply-constrained. We estimated the effect of decisions surrounding the allocation of constrained doses on the potential global impact of M72/AS01E

Part of Change 2.0

Actionable market intelligence, including vaccine demand forecast/scenarios, generated to strategically guide manufacturers and partners in their planning for introduction in high burden countries. The objectives include: 1. Strategic assessment of appropriate market-shaping interventions, 2.Stakeholder and decision process mapping , 3.Demand dynamics understanding and realistic market forecast development, 4. Commercialization strategy support for lead candidate(s).

Modelling to estimate the health impact of novel tuberculosis vaccines on TB burden in people living with HIV

This project will inform tuberculosis (TB) prevention efforts by estimating the health impact of novel tuberculosis vaccines on TB burden in people living with HIV (PLHIV) using a novel Mycobacterium tuberculosis transmission model. HIV confers the largest relative risk of TB, and new TB vaccines could be an important tool to prevent TB; however, modelling studies have not systematically investigated how new vaccines will affect TB burden in PLHIV. In stage 1 of this project, we aim to investigate TB vaccine impact in PLHIV where vaccine product characteristics and delivery vary by recipient HIV status. In stage 2, we aim to quantify how complex vaccine targeting strategies and incorporating additional granularity in HIV/AIDS natural history might affect vaccine impact estimates in PLHIV

Epidemiologic study to assess the IGRA positivity in populations with a high TB

Tuberculosis (TB) vaccine efficacy trials evaluating prevention of disease must be feasible in size and duration and would ideally take place at clinical trial sites that enroll from communities with the highest incidence rates. In preparation for the Phase 3 trial of the investigational M72/AS01E-4 vaccine, we conducted a multi-country study, using interferon gamma release assay (IGRA) positivity as a proxy for expected incidence of TB. In addition to the above objects, the results from this study could help in in new vaccine introduction to identfy TB hotspot areas.
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