Background
Tuberculosis (TB) is the leading cause of death from an infectious agent worldwide, a major contributor to mortality among people with HIV and a significant driver of antimicrobial resistance. An estimated 10.7 million people fell ill with TB in 2023, mostly in low- and middle-income countries, and about a quarter of the world’s population has been infected with Mycobacterium tuberculosis. This population is at risk of developing TB disease. In 2023, TB was responsible for an estimated 1.25 million deaths.
The World Health Organization (WHO) seeks to advance the development and deployment of new TB vaccines to prevent TB disease, with a focus on adolescents and adults in whom 90% of TB disease occurs. TB prevention in these populations, responsible for most of the transmission, will have a significant impact on reducing TB disease and incidence in those at risk, including unvaccinated infants, children, older adults and other key populations, such as people living with HIV. There are several vaccine candidates in the pipeline, many in late-stage development, and effort is needed to co-ordinate and where feasible align on regulatory expectations, provide guidance on clinical aspects such as optimal clinical endpoints and on anticipated evidence needs for policy at the global, regional and national levels.
As such, the primary remit of this new Technical Advisory Group on Evidence for Clinical and Policy Considerations for New Tuberculosis (TB) Vaccines will be to focus on the research and development phase of new TB vaccines, to participate in reviews of data and product development strategies from developers, and to advise WHO on the generation of evidence related to clinical and policy considerations to inform the TB vaccine development community.
Objectives
- To provide independent advice related to the scientific and strategic clinical, regulatory and policy aspects related to new TB vaccine candidates, including but not limited to safety, immunogenicity, efficacy, anticipated impact and effectiveness, resulting in recommendations on data requirements, study designs, clinical trial protocols and regulatory strategies.
- To advise WHO on evidence to support policy formulation, optimal programmatic delivery strategies and where appropriate implementation science to accelerate the pathway to recommendation, introduction and use of new TB vaccines at the country and global levels.
- To assist the secretariat in developing novel guidance and communication on WHO positions with respect to aspects such as clinical endpoints, case definitions, expected data and evidence needs, trade-offs, to inform investment and introduction decision-making.
Membership
The Technical Advisory Group on Evidence for Clinical and Policy Considerations for New Tuberculosis (TB) Vaccines (TAG) has up to 25 members, who serve in their personal capacities to represent the broad range of disciplines relevant to novel TB vaccines. In the selection of the TAG members, consideration is given to attaining an adequate distribution of technical expertise, geographical representation and gender balance. Two co-chairs are selected whose role it is to chair the meeting of the TAG and to liaise with the WHO Secretariat between meetings. In appointing a chair, consideration is given to gender and geographical representation. Members of the TAG are appointed to serve for a period of 2 years and are eligible for reappointment. A chair is eligible for reappointment as a member of the TAG but is only permitted to serve as chair for one term.
Meetings
The TAG shall normally meet face-to-face at least once each year, and virtually up to 8 times per year for up to 3 hours. However, WHO may convene additional meetings. TAG meetings may be held in person (at WHO headquarters in Geneva or another location, as determined by WHO) or virtually, via video or teleconference.
Meeting reports
All →Meeting reports will be made available online in due course.