Value profile for Malaria vaccines and monoclonal antibodies

Malaria remains a leading cause of morbidity and mortality and is responsible for over 0.5 million annual deaths globally. During the first two decades of this century, scale-up of a range of tools was associated with significant reductions in malaria mortality in the primary risk group, young African children. However, in recent years progress has stalled and even reversed in some high-burden countries, highlighting the urgent need for new interventions. Since 2021, two malaria vaccines have received World Health Organization (WHO) recommendations and Gavi, the Vaccine Alliance financing and are now in high demand across sub-Saharan Africa. Despite their promise, including a 13 % decline in all-cause mortality and a 22 % drop in severe malaria hospitalizations following pilot introduction, there remains keen interest in developing improved vaccines in alignment with WHO's preferred product characteristics (PPCs), revised in 2022 (see https://www.who.int/publications/i/item/9789240057463). Further, monoclonal antibody (mAb) prophylaxis has emerged as a promising new intervention, which led to WHO's developing a new guidance document to inform PPCs for malaria mAbs (see https://www.who.int/publications/i/item/9789240070981). The priority focus for these aspirational tools is on prevention of disease and death in young African children; however, there is increasing focus on tools that could be deployed across entire populations to break the cycle of parasite transmission and accelerate elimination. Further, accelerated impact of next-generation vaccines is emerging thanks to the pioneering introduction of current vaccines into established national immunization programs and strong coordination with national malaria programs. This vaccine value profile (VVP) for malaria-developed by a working group of subject matter experts from academia, nonprofit and multilateral organizations, and public-private partnerships-provides a high-level, holistic assessment of current, existing information and data that are publicly available to inform the potential public health, economic, and societal value of vaccines and prophylactic mAbs in the development pipeline.