The RTS,S malaria vaccine was shown in a large phase-3 trial to be efficacious and generally well tolerated. Modelling estimates indicate that its addition to current malaria-control measures could save tens of thousands of lives.
In 2019, the Ministries of Health in Malawi, Ghana and Kenya with support from the World Health Organization (WHO) introduced on pilot basis the RTS,S malaria vaccine. Through the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP) more than 800,000 children have been vaccinated in the three African countries. The vaccine implementation is accompanied by an independent evaluation (Malaria Vaccine Pilot Evaluation, MVPE), to assess the safety of RTS,S in routine use, the feasibility of reaching children with the recommended four-dose schedule, and the impact of the vaccine at population level to inform global policy recommendation.
As part of the MVPE, the MVPE-CC project uses case-control studies to estimate excess risk of meningitis and cerebral malaria, and of mortality in girls, associated with RTS,S vaccination. In addition to these safety signals observed as part of the phase-3 trial, the studies will estimate vaccine effectiveness in preventing severe malaria in children, the importance of rebound effects, and the incremental benefit of receiving the 4th dose of RTS,S. The project also aims to promote the use of case-control approaches by the Expanded Programme of Immunization (EPI) and malaria control programmes in high-burden countries, strengthening their capacity to monitor the safety and effectiveness of malaria vaccines.
MVPE-CC will make important contributions to policy decisions and will help maximize acceptability, uptake and impact, after WHO’s recommendation for widespread use of the RTS,S malaria vaccine among children in sub-Saharan Africa.