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TB Vaccine Development Pathway – new updates and guidance available

The Tuberculosis Vaccine Initiative (TBVI) and IAVI have updated the TB Vaccine Development Pathway. This online tool provides a structured development path and gating criteria for TB vaccine candidates and may be useful for vaccine development in general.

In addition to TB specific considerations and target population considerations, the updated Pathway now includes vaccine technology specific considerations. In the field of vaccinology, new technological platforms have emerged, each with specific challenges in their development. The Pathway now includes considerations for inactivated and live/attenuated, adjuvanted subunit, viral vectored and DNA/RNA vaccines.

Guidance on planning and operating ‘community engagement’ activities has also been added. These activities aim at building relationships and working collaborations in the field, and are initiated at Stage C (Preclinical Evaluations) of the Pathway.

Finally, the market, access and implementation (MAI) function which ultimately aims to secure introduction of a TB vaccine into national immunisation programmes, describes the main steps of a comprehensive approach initiated in early development stages.


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. The first revision resulted in the publication of the online TB Vaccine Development Pathway in 2018. Based upon consultations and as new knowledge and insights emerged from the field, the stage gate criteria have again been updated, and published online in June 2021.

“On behalf of the Working Group members I want to thank the whole TB vaccine community for joining us in this huge collaborative effort. The breadth and scope of this project is exceptional. Our deepest hope is that the TB Vaccine Development Pathway will contribute to the creation of safe and effective TB vaccines that will put an end to one of the biggest threats to our global health.“ Georges Thiry, Chairman of the Working Group

Feedback from users welcome

The field of TB vaccine development is dynamic by nature and users of the TB Vaccine Development Pathway are encouraged to provide us with feedback, ideas and insight by using the contact form of the online tool, with the aim to incorporate new developments and best practice for the benefit of all.


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 challenging. The TB Vaccine

Development Pathway serves as a guidance tool to help developers consider all the stages of development and to advance a vaccine to its next stage of development.

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 funded by the Bill & Melinda Gates Foundation.

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