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Availability

Availability refers to sufficient, sustainable and timely supply of new TB vaccines for adults and adolescents. This includes having demand assessed for different population groups, defining policy and evidence needs, and having procurement plans in plans. This follows from the WHO global framework for country introduction of new adolescent and adult TB vaccines (https://www.who.int/publications/m/item/who-global-framework-to-prepare-for-country-introduction-of-new-tb-vaccines-for-adults-and-adolescents)

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.

Scoping Community Interventions to Support New TB Vaccine Introduction: From Grassroots Partnerships to Global Policymaking

To assess the role of communities and civil society in shaping TB vaccine introduction policies, implementation and equitable access. Aim 1: Map the structures, networks, and major players active in TB civil society and overlay these with the policy pipeline for new TB vaccines. Aim 1: Map the structures, networks, and major players active in TB civil society and overlay these with the policy pipeline for new TB vaccines. Aim 2: work with members of the regional community advisory boards (rCABs) established with support from the USAID-funded SMART4TB project to produce country policy portraits illustrating how TB and immunization policy is made in selected countries and the points where community and civil society actors can intervene. Aim 3: work with the rCAB in the Eastern Europe and Central Asia (EECA) region to explore interventions by community and civil society to ensure equitable access to new TB vaccines. All three Aims will be completed in relation to the ECVP and the Global Framework for Country Introduction of New TB Vaccines.

Measuring indirect transmission-reducing effects in tuberculosis vaccine efficacy trials: why and how?

Tuberculosis is the leading bacterial cause of death globally. In 2021, 10·6 million people developed symptomatic tuberculosis and 1·6 million died. Seven promising vaccine candidates that aim to prevent tuberculosis disease in adolescents and adults are currently in late-stage clinical trials. Conventional phase 3 trials provide information on the direct protection conferred against infection or disease in vaccinated individuals, but they tell us little about possible indirect (ie, transmission-reducing) effects that afford protection to unvaccinated individuals. As a result, proposed phase 3 trial designs will not provide key information about the overall effect of introducing a vaccine programme. Information on the potential for indirect effects can be crucial for policy makers deciding whether and how to introduce tuberculosis vaccines into immunisation programmes. We describe the rationale for measuring indirect effects, in addition to direct effects, of tuberculosis vaccine candidates in pivotal trials and lay out several options for incorporating their measurement into phase 3 trial designs

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).
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