Full Evidence Report on the R21/Matrix-M Malaria Vaccine

In October 2021, WHO recommended the first malaria vaccine, RTS,S/AS01, for the prevention of Plasmodium falciparum (P. falciparum) malaria in children living in regions with moderate to high transmission, as defined by WHO. The vaccine can be given as a 3-dose primary schedule with a later fourth dose to prolong duration of protection. In areas of highly seasonal malaria or perennial malaria transmission with seasonal peaks, countries may consider providing the vaccine in a 5-dose strategy seasonally, just prior to the peak transmission season, to increase impact. Given the ongoing challenge of malaria burden reduction, the demonstrated value of a safe and effective malaria vaccine as a complementary malaria control tool, the insufficient supply of RTS,S/AS01, and the interest in a healthy malaria vaccine market, there remains a continued need for new malaria vaccines such as R21/Matrix-M, should the evidence demonstrate their safety and potential public health impact.

This report was prepared by the SAGE/MPAG Working Group on Malaria Vaccines to support the joint review of the R21/Matrix-M malaria vaccine by the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Group (MPAG).