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 marketing authorisation, 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.

Stage gate criteria

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. 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 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. In 2020 Tuberculosis published the article ‘The TB vaccine development pathway – An innovative approach to accelerating global TB vaccine development’. This publication emphasizes the importance of a diverse TB vaccine pipeline to address the TB-specific challenges and the importance of individual vaccine candidates to be advanced rationally and the global pipeline must be managed in the most nimble and resource-efficient way.

The criteria and guidance have been updated in 2021.

Contributors to the Pathway

TBVI: Georges Thiry, Leo van der Pol, Ann Rawkins, Bernard Fritzell, Emmanuelle Gerdil, Anne Marie Graffin, Gerald Voss, Barry Walker, Jelle Thole, Danielle Roordink, Marit Holleman, Ilona van den Brink.

IAVI: Maria Lempicki, Ann Ginsberg. Dereck Tait, Danilo Casimero, Dominick Laddy.

We would like to acknowledge the invaluable contributions and feedback from the TB community around the world.

Partners behind the Pathway

The TB Vaccine Development Pathway was established by a team of scientific and technical experts from TBVI and IAVI with the input of the TB vaccine community. The tool has been developed on behalf of the Global TB Vaccine Partnership (GTBVP) and is funded by the Bill & Melinda Gates Foundation.

The GTBVP is an alliance of organisations that aim at making novel TB vaccines a reality.