WHO Consultation: Preferred product characteristics for monoclonal antibodies for malaria prevention
The WHO Global Malaria Programme (GMP) and the Department for Immunization, Vaccines and Biologicals are seeking public comments on the following preferred product characteristics (PPCs) for monoclonal antibodies for malaria prevention.
The PPCs here aim to promote the development of malaria monoclonal antibodies (mAbs) with high public health impact and suitability for use in low- and middle-income countries (LMICs). They have been jointly developed by the Global Malaria Programme, the Department of Immunization, Vaccines and Biologicals (IVB) and a Scientific Development Committee of experts. The malaria mAbs PPCs address several considerations including indication, target population, safety and efficacy, formulation and presentation, dose regimen, co-administration, route of administration, product stability and storage, and access and affordability. These preferences are shaped by the unmet public health needs in priority disease areas as well as the realities of the disease epidemiology and delivery systems in the target geographies.
WHO’s PPCs aim to:
- communicate unmet public health needs;
- stimulate the development of relevant new products to meet those needs;
- facilitate the timely, effective assessment of new products, and the formulation of relevant policy recommendations and prequalification listings.
In the current landscape of malaria control, mAbs for malaria prevention may offer several advantages over existing tools, as stand-alone products or when combined with existing tools. The ultimate aim of any malaria mAb is to reduce morbidity and mortality, which can be achieved directly by preventing blood stage infection or reducing blood stage parasite density.
Read the draft for consultation here.
Interested parties can provide comments using the following online survey.
Survey deadline August 12, 2022.
