Malaria vaccines: preferred product characteristics and clinical development considerations

Book excerpt: 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.