Gonococcal vaccines: Public health value and preferred product characteristics; report of a WHO global stakeholder consultation, January 2019.

Renewed interest in developing vaccines against Neisseria gonorrhoeae has been sparked by the increasing threat of gonococcal antimicrobial resistance (AMR) and growing optimism that gonococcal vaccines are biologically feasible. Evidence suggests serogroup B Neisseria meningitidis vaccines might provide some cross-protection against N. gonorrhoeae, and new gonococcal vaccine candidates based on several approaches are currently in preclinical development. To further stimulate investment and accelerate development of gonococcal vaccines, greater understanding is needed regarding the overall value that gonococcal vaccines might have in addressing public health and societal goals in low-, middle-, and high-income country contexts and how future gonococcal vaccines might be accepted and used, if available. In January 2019, the World Health Organization (WHO) convened a multidisciplinary international group of experts to lay the groundwork for understanding the potential health, economic, and societal value of gonococcal vaccines and their likely acceptance and use, and for developing gonococcal vaccine preferred product characteristics (PPCs). WHO PPCs describe preferences for vaccine attributes that would help optimize vaccine value and use in meeting the global public health need. This paper describes the main discussion points and conclusions from the January 2019 meeting of experts. Participants emphasized the need for vaccines to control N. gonorrhoeae infections with the ultimate goals of preventing adverse sexual and reproductive health outcomes (e.g., infertility) and reducing the impact of gonococcal AMR. Meeting participants also discussed important PPC considerations (e.g., vaccine indications, target populations, and potential immunization strategies) and highlighted crucial research and data needs for guiding the value assessment and PPCs for gonococcal vaccines and advancing gonococcal vaccine development.

Advancing point of care diagnostics for the control and prevention of STIs: the way forward.

WHO recognises the global impact of sexually transmitted infections (STIs) on global public health and individual sexual and reproductive health and well-being. As a component of the WHO Global Health Sector Strategy for the control and prevention of STIs, there has been a growing recognition of the importance of integrating point-of-care tests (POCTs) into overall strategic planning. The process of integrating STI POCTs, in addition to providing a definitive diagnosis and appropriate treatment in a single visit, also includes innovative delivery options, such as on-site delivery, community-based testing (including screening), as well as self-testing at home after purchase of a test online or over-the-counter. WHO organised two technical consultations in May 2014 and July 2015. This article summarises the discussions of the meeting participants on advancing the use of POCTs to control and prevent STIs. The following priorities were identified: the need for pathogens' target discovery; encouragement of multiplexing, miniaturisation, simplification and connectivity; promotion of standardisation of evaluation of new diagnostic platforms across all stages of the evaluation pipeline; the need for an investment case, modelling and scenarios to ensure buy-in among key stakeholders, including developers and the private sector; the need for norms and standards, including guidelines, to support introduction of STI POCTs in programmes; anticipating potential tensions between different parties at the implementation level; and leveraging on the global initiative, Sustainable Development Goals (SDGs)/global health sector STI strategy, to sustain investment in STI POCT programmes. There is a rich pipeline of diagnostic products, but some have stalled in development. An approach to accelerate the evaluation of new diagnostics is to set up a competent network of evaluation sites ahead of time, harmonise regulatory approval processes with development of models to estimate cost-effectiveness, informed by better STI data. This should result in accelerating policy development. Although it may be some time before good POCTs can be widely implemented in low resource settings, it is important to be a catalyst for continued development and use of these essential tools as an integral part of both the WHO Global Health Sector Strategy and the agenda for 2030.