The Tuberculosis Vaccine Initiative (TBVI) and IAVI have recently updated and expanded the TB Vaccine Development Pathway, a methodology and tool that provides a structured development path and gating criteria for candidate TB vaccines. The Pathway, which was first announced in September 2018, now includes Stage Gates for vaccine registration and launch, as well as guidance specific to the development of vaccines for adolescent/adults, neonates, and for vaccines to be used in a therapeutic setting.
The development of novel tuberculosis (TB) vaccines remains a global priority in the effort to end TB. Recent clinical studies have provided efficacy signals for prevention of TB infection and disease, and these results indicate that it is feasible to develop new tuberculosis vaccines to impact the global epidemic.
While these lead vaccine approaches continue in late stage development, it remains critical to maintain a broad portfolio of vaccine candidates, based on different vaccine technologies, and that aim at a variety of target populations and indications.
Decision making support
Progressing a TB vaccine candidate to the next step of development requires complex decision making for vaccine developers and funders. This is particularly true for TB vaccines, because the field lacks correlates of protection for vaccine efficacy and a predictive animal model, and because the funding environment is restricted.
The Tuberculosis Vaccine Development Pathway was created with the aim to support and facilitate decision making in TB vaccine development by providing evidence-based, unbiased technical guidance and support. The Pathway divides the development of a vaccine against TB into successive Stages, separated by Stage Gates, complemented with guidance on their use.
Novel TB vaccines could be used in different populations and indications, and this has an impact on the way they are developed. To reflect these specificities, the TB Vaccine Development Pathway now includes specific guidance for development of vaccines for three populations: adolescent/adults, neonates, and people with TB disease. The guidance is aligned with published WHO Preferred Product Characteristics for each population and/or indication to ensure any eventual product is matched with the needs of the target population.
About the TB Vaccine Development Pathway
The TB Vaccine Development Pathway was established by TBVI and IAVI experts, with input from the research community, international policy makers, technical agencies and funders. The Pathway 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. The Pathway is funded by the Bill & Melinda Gates Foundation, and is revised every two years to incorporate scientific and technical progress, and input from users.