About
Achieving Global Health impact with a vaccine encompasses everything from a brilliant idea for anew or improved vaccine to improving the lives of people worldwide.
This road can be split in two with the milestone of a marketed vaccine in the middle: the development of a vaccine product and the implementation of the new vaccine. This tool is a guidance for the first part: developing a vaccine against TB.
The development of a TB vaccine 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 TBVaccine Development Pathway is built on the importance of a diverse TB vaccine pipeline and of individual vaccine candidates to be advanced rationally to manage the global pipeline in the most nimble and resource-efficient way and to address the unique challenges of TB.Therefore, the TB Vaccine Development Pathway serves as a guidance tool for developers, helping them consider all the functions of development and facilitating the efficient advancement of TB vaccines to its next stage of development.
Stage gate criteria
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 several times to include new knowledge and insights emerging from the field
Contributors to the Pathway
Revision 2026 (revision foreseen to be available February 2026)
Coordinator: TBVI (Marit Holleman and Elly van Riet)
Advisory group: Ann Ginsberg, Ann Rawkins, Bernard Fritzell, Lew Schrager
Working Group Preclinical: Katrin Eichelberg (NIH) (chair), Frank Verreck (BPRC), SimonClark (UKHSA), Alison Kraigsley (BMGF), Louis Ates (BioNTech), Kevin Urdahl (Seattlechildrens)
Working Group Clinical: Gavin Churchyard (Aurum Institute) (chair), Mark Hatherill (UCT), Frank Cobelens (AIGHD), Alvaro Borges (SSI), Ann Ginsberg (GF),Elana Van Brakel (IAVI), Badri Narayan Patnaik (Bharat Biotech), AlexanderSchmidt (Gates MRI), Bernard Fritzell (TBVI)
Funders: BMBF/KfW, Dutch Ministry of Health
Introductory video: TBVI, We are cognitive, Dutch Ministry of Health
2012
First publication ‘Rational approach to selection and clinical development of TB vaccine candidates’ describing the development of objective criteria are described for a number of key general vaccine characteristics which can be assessed at critical stages of development. This formed the foundation of the current TBVaccine Development Pathway.
Edition 2018 and 2021
The TBVaccine Development Pathway was established by a team of scientific and technical experts from TBVI and IAVI with the input of the TB vaccine community.
TBVI:Georges Thiry, Leo van der Pol, Ann Rawkins, Bernard Fritzell, Emmanuelle Gerdil, Anne Marie Graffin, Gerald Voss, Barry Walker, Jelle Thole, DanielleRoordink, Marit Holleman, Ilona van den Brink.
IAVI: Maria Lempicki, Ann Ginsberg. DereckTait, Danilo Casimero, Dominick Laddy.
We would like to acknowledge the invaluable contributions and feedback from the TB community around the world as well as the partners behind the pathway:
The tool has been developed on behalf of the Global TB Vaccine Partnership (GTBVP), an alliance of organisations that aim at making novel TB vaccines a reality, and was funded by the Bill & Melinda Gates Foundation.
