Prevention of disease refers to the ability of the vaccine to protect individuals from becoming sick from the tuberculosis (TB) bacteria after exposure to it. It does not necessarily prevent a person from getting infected with the TB bacteria.
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.