Malaria Chemoprevention Preferred Product Characteristics

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 drugs for malaria chemoprevention. WHO recommends several chemoprevention strategies for malaria control, including seasonal malaria chemoprevention, perennial malaria chemoprevention, intermittent preventive treatment of malaria in pregnancy, and mass drug administration. These strategies face a number of challenges such as suboptimal adherence and coverage and the emergence and spread of drug resistance. This document presents PPCs for the development of drugs for malaria chemoprevention in children, in pregnancy and in non-immune travellers, and outlines potential clinical development approaches, including the repurposing of approved malaria treatments for use as chemoprevention, recombining approved individual drugs into new combinations for malaria prevention, and the development of new drug combinations specifically for chemoprevention.

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.

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.

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.

On 18–20 April 2023, the WHO Malaria Policy Advisory Group (MPAG) convened to review updates and progress, and to provide guidance on thematic areas of work by the Global Malaria Programme. The meeting focused on the following topics: 1) the RBM Partnership to End Malaria evaluation of the “High burden to high impact” (HBHI) approach; 2) updates on the vector control, treatment and diagnostic recommendations in the WHO guidelines for malaria; 3) revisiting comparative effectiveness in the context of the arrival of new vector control products; 4) an update on certification of malaria elimination and the E-2025 Global Forum; 5) an update on the RTS,S/AS01 Malaria Vaccine Implementation Programme and WHO evidence review for the R21/Matrix-M vaccine; 6) an update on the work areas of the Strategic Information for Response Unit; 7) a report from the technical consultation on the effectiveness of rectal artesunate (RAS) and field implementation manual; 8) a report from the technical consultation on community-based delivery of intermittent preventive treatment of malaria in pregnancy (IPTp); 9) an update on the WHO/TDR field implementation manual for seasonal malaria chemoprevention (SMC); 10) an update on the Anopheles stephensi regional strategy; 11) an update on histidine-rich protein 2 (HRP2) gene deletions and global response plan; and 12) an update on antimalarial drug resistance in Africa.

On 4–7 October 2021, the WHO Malaria Policy Advisory Group (MPAG) convened virtually to review updates and progress, and to provide guidance on thematic areas of work by the Global Malaria Programme. The meeting focused on 8 topics in 5 open sessions: 1) “Rethinking Malaria”; 2) update on the technical consultation on non-inferiority evaluations of vector control tools; 3) a discussion on malaria re-bound; 4) an update on antimalarial drug resistance in Africa; 5) an update on rectal artesunate (RAS) and quality of care; 6) a review of the relationship between chemoprevention and drug resistance; 7) an update on the WHO guidelines for malaria; and 8) a joint session with the Strategic Advisory Group of Experts on Immunization (SAGE) to review the evidence and consider a recommendation for broader use of the malaria vaccine.