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Availability

Availability refers to sufficient, sustainable and timely supply of new TB vaccines for adults and adolescents. This includes having demand assessed for different population groups, defining policy and evidence needs, and having procurement plans in plans. This follows from the WHO global framework for country introduction of new adolescent and adult TB vaccines (https://www.who.int/publications/m/item/who-global-framework-to-prepare-for-country-introduction-of-new-tb-vaccines-for-adults-and-adolescents)

TPTVaxx

2024
Planned
Vaccines will be introduced in contexts where TPT already exists. Exploration of possible study designs, expected effectiveness, feasibility of integrated approaches is key.

Evidence considerations for vaccine policy development for tuberculosis vaccines intended for adults and adolescents

2023
Hypothetical vaccines
Completed
The ECVP facilitates early engagement and alignment across the stakeholders involved in vaccine development and those responsible for vaccine regulatory, policy, funding and country introduction decisions. This framework aims to anticipate and collectively delineate the clinical trial, observational, and other data likely to be required by global and national policymakers, and to do so when most valuable – during development of the late-stage clinical plan, including the design of the pivotal licensure trial.

A global framework to prepare for country introduction of new TB vaccines for adults and adolescents

2023
Completed
New vaccines for the prevention of TB disease in adolescents and adults could become available in the next 3-5 years. WHO has therefore developed a Global Framework to prepare for Country Introduction of New TB Vaccines for Adults and Adolescents which aims to guide countries and global stakeholders in preparing for the introduction and scale-up in countries. This framework has been drafted in collaboration with a WHO Expert Advisory Group and in consultation with other stakeholders, and describes critical activities to prepare for introduction decision-making and subsequent implementation and impact of new TB vaccines for adults and adolescents. 

Preferred product characteristics for new tuberculosis vaccine

2018
Hypothetical vaccines
Completed
The document presents WHO preferences for new tuberculosis vaccines, driven by the high medical need for contribution to the fight against TB, in alignment with the End TB strategy. Priorities are for a vaccine to be administered to adolescents and adults for prevention of pulmonary tuberculosis and reduction of transmission, and for a pediatric vaccine with improved safety and efficacy as compared to BCG.

Preferred product characteristics for therapeutic vaccines to improve tuberculosis treatment outcomes

2019
Completed
The preferred product characteristics (PPC) for therapeutic TB vaccines described in this document are intended to provide guidance to scientists, funding agencies, public and private sector organizations developing such vaccine candidates. This document presents potential clinical end-points for ev idence generation and discusses key considerations about potential clinical development strategies
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