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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).

Evidence considerations for vaccine policy development for tuberculosis vaccines intended for adults and adolescents

The ECVP facilitates early engagement and alignment across the stakeholders involved in vaccine development and those responsible for vaccine regulatory, policy, funding and country introduction decisions. This framework aims to anticipate and collectively delineate the clinical trial, observational, and other data likely to be required by global and national policymakers, and to do so when most valuable – during development of the late-stage clinical plan, including the design of the pivotal licensure trial.
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