The development of vaccines can be divided into stages, from discovery to implementation. The decision to move a vaccine candidate to the next stage is difficult, and even more so for TB vaccines because of the lack of a correlate of protection, of predictive animal models, of precedence for obtaining market authorization, and the restricted amount of funding available.
The TB Vaccine Development Pathway serves as a guidance tool to help developers consider all the functions of development and to advance a vaccine to its next stage of development.
The TB Vaccine Development Pathway uses a stage gate criteria approach. In this approach, activities are defined and performed for each stage of the development process. The gate presents a list of criteria for the vaccine candidate to progress to the next stage, or not (see example below). The stage gate criteria are intended to help developers and funders make investment decisions for the next stage of development.
Since their first publication in 2012, the stage gate criteria for TB vaccine development have been thoroughly revised by TBVI and Aeras, with input from a wide range of stakeholders. As new knowledge and insights emerge from the field, the stage gate criteria will be re-evaluated. An updated set of criteria are planned for 2020.