In what can be considered a “historic” move forward in the fight against malaria, the World Health Organization (WHO) has recommended widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children at risk of P. falciparum malaria.
Malaria remains a major cause of childhood morbidity and mortality, particularly in sub-Saharan Africa, where over 94% of all cases occur. More than 260 000 children in Africa under the age of five die from malaria annually. A safe and effective vaccine is widely considered as the essential component in the fight against the disease.
Over a period of 30 years GlaxoSmithKline (GSK) has been leading the development of the RTS,S malaria vaccine in a partnership with PATH’s Malaria Vaccine Initiative (MVI) and a network of African research centers. In 2019, Ghana, Kenya and Malawi introduced RTS,S on pilot basis through the WHO-coordinated Malaria Vaccine Implementation Program (MVIP) that has reached more than 800,000 children to date. Major findings of the pilot included that the vaccine has a strong safety profile, is cost-effective, can be delivered through routine immunization systems and reduces severe malaria by about 30%.
Based on these key findings, WHO now recommends widespread use of RTS,S among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission.
The ongoing vaccine implementation is accompanied by an independent Malaria Vaccine Pilot Evaluation (MVPE). The European Vaccine Initiative (EVI) is partnering with leading African clinical trial centers, European and global institutions to undertake case control studies as part of the MVPE (MVPE-CC).
Dr Ole Olesen, Executive Director EVI, says: “EVI is proud to be associated with efforts to consolidate evidence for widespread use of the RTS,S malaria vaccine, and to strengthen capacity of national malaria control programs to monitor and evaluate malaria vaccines after their introduction.”
The main objectives of MVPE-CC are to assess vaccine effectiveness against severe malaria in children, the incremental benefit of the currently recommended four-dose over a three-dose schedule of RTS,S in routine use, and the association of RTS,S with safety signals identified in the Phase 3 trial. The project also aims to promote the use of case-control approaches by the Expanded Program on Immunization (EPI) and malaria control programs in high-burden countries, strengthening their capacity to monitor the effectiveness of malaria vaccines.
The findings of MVPE-CC will be instrumental for wider use of RTS,S at global and country level, inform policy decisions, and will help to maximize acceptability, uptake and impact of the vaccine.
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