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Hypothetical vaccines

A hypothetical TB vaccine refers to a vaccine that currently does not exist. It is a hypothetical scenario with a vaccine that may protect against infection and/or disease and/or recurrence to a certain extent. Usually WHO guidance is followed to inform these hypothetical vaccines (An investment case for new tuberculosis vaccines (who.int).

Evaluating vaccination strategies for tuberculosis in endemic and non-endemic settings

We propose a continuous age-structured model for the epidemiology of tuberculosis with pre- and post-exposure vaccination. We use uncertainty and sensitivity analysis to make predictions about the efficacy of different vaccination strategies in a non-endemic setting (United States) and an endemic setting (Cambodia). In particular, we determine optimal age groups to target for pre-exposure and post-exposure vaccination in both settings.

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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