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Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for new malaria vaccines. WHO PPCs were initially conceived in 2012-2013 as a class of research-oriented normative guidance documents. The first edition of the WHO PPCs for malaria vaccines (WHO/IVB/14.09), published in 2014, was the first-in-class of these documents. The document published here is an update to the 2014 edition. Since the first malaria vaccine PPCs were published in 2014, major milestones in malaria vaccine R&D have been achieved. In 2021, RTS,S/AS01 became the first malaria vaccine to be recommended by WHO for use in moderate- to high-transmission settings in sub-Saharan Africa. However, a healthy market of vaccines will be needed to meet the global demand. A continued focus on developing new and improved vaccines will be vital in our efforts to reduce global malaria burden and to achieve elimination and eradication. This includes malaria vaccines to prevent blood-stage infection, reduce morbidity and mortality, and/or reduce community-level transmission.
Preferred product characteristics (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for monoclonal antibodies (mAbs) for malaria prevention. Alongside the development of new malaria vaccines and chemoprevention drugs, there have been recent R&D advances in the development of mAbs for malaria prevention. Passive immunization with mAbs through direct administration of functional antibodies could potentially overcome some of the limitations of vaccines by providing immediate protection. Furthermore, mAbs with simplified dose regimens could potentially circumvent some of the coverage and adherence issues faced by malaria chemoprevention. To support this quickly developing R&D area, WHO convened a scientific development group to consider the PPCs for mAbs to be used for malaria prevention, with a focus on the reduction of morbidity and mortality in infants and children due to Plasmodium falciparum.
Each year, WHO’s World malaria report offers in-depth information on the latest trends in malaria control and elimination at global, regional and country levels. The report highlights progress towards global targets and describes opportunities and challenges for curbing and eliminating the disease. This year’s report includes three new sections on: (1) global and regional initiatives launched in 2021 and 2022; (2) global malaria surveillance and country-level case studies on surveillance systems assessments; and (3) research and development. The report also includes an expanded section on threats to malaria control, with a focus on the declining effectiveness of insecticide-treated mosquito nets.
This document describes the main elements that World Health Organization (WHO) technical departments should elaborate on when providing guidance on evidence generation to research and development (R&D) specialists who are developing health products to address critical unmet needs in public health. While WHO’s TPPs, preferred product characteristics (PPCs) and target regimen profiles (TRPs) provide high-level information on the desired characteristics of the product, the target population, and the key endpoints for safety and efficacy evaluation, more detailed guidance is needed to enable the development of suitable trial/study designs aimed at producing relevant evidence for WHO’s normative products such as guidelines. The objective of the Guidance for evidence generation (GEG) process is to produce a guidance document on how best to perform studies for the development of novel products (diagnostics, drugs, vaccines, vector control) and thus how to enable the generation of robust data and evidence to inform a WHO evidence review process.
On 27–28 October 2020, the WHO Initiative for Vaccine Research and Global Malaria Programme convened a meeting of the Malaria Vaccine Advisory Committee (MALVAC) to review priority issues in product development in malaria vaccine research and development (R&D). Experts reviewed major use case scenarios for malaria vaccines, including the reduction of morbidity and mortality, and the reduction of malaria transmission. Other potential use case scenarios were also discussed, including seasonal vaccination, vaccination to prevent malaria in pregnancy, and vaccines targeting non-Plasmodium falciparum species such as P. vivax. MALVAC members discussed how best to update and build on the previously developed malaria vaccine Preferred Product Characteristics (PPCs), bearing in mind advances in the field and lessons learned from the development and evaluation of the RTS,S/AS01E vaccine.
The goal of the present guideline is to consolidate guidance for effective interventions that are needed to reduce the global burden of maternal infections and its complications around the time of childbirth. This forms part of WHO's efforts towards improving the quality of care for leading causes of maternal death especially those clustered around the time of childbirth in the post-MDG era. Specifically it presents evidence-based recommendations on interventions for preventing and treating genital tract infections during labour childbirth or puerperium with the aim of improving outcomes for both mothers and newborns. The primary audience for this guideline is health professionals who are responsible for developing national and local health protocols and policies as well as managers of maternal and child health programmes and policy-makers in all settings. The guideline will also be useful to those directly providing care to pregnant women including obstetricians midwives nurses and general practitioners. The information in this guideline will be useful for developing job aids and tools for both pre- and inservice training of health workers to enhance their delivery of care to prevent and treat maternal peripartum infections.