Malaria vaccines have been in development since the 1960’s, with substantial progress in the last decade. October 6, 2021, marks an historic day in the development of malaria vaccines, with release of the World Health Organization (WHO) recommendation for widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children living in sub-Saharan Africa and other regions with moderate to high P. falciparum malaria transmission. Notably, the vaccine provided this protection in settings with ongoing use of other effective malaria prevention and treatment interventions: bed nets, antimalarial drugs for disease treatment, indoor residual insecticide spraying to prevent mosquito-borne transmission, and drugs to protect pregnant women and their newborns from malaria’s adverse effects.
In July 2015, the European Medicines Agency (EMA) gave a positive regulatory assessment of the RTS,S/AS01 vaccine for 5–17-month-olds, but WHO recommended in October 2015 that the vaccine be further evaluated in large-scale pilot studies before recommending it. Large-scale pilots of the vaccine began in Ghana, Kenya, and Malawi in 2019, including several hundreds of thousands of infants. CDC, in collaboration with KEMRI and several other organizations, is leading the evaluation of the large-scale RTS,S/AS01 pilot in western Kenya. The goal of these pilot evaluations is to assess the feasibility of delivering the three-dose vaccine series plus booster through routine health systems, carefully examine the relationship of the vaccine to specific adverse events (febrile seizures, meningitis, cerebral malaria), and also evaluate its impact on all-cause mortality. CDC, in collaboration with KEMRI and several other organizations, will lead the evaluation of the large-scale RTS,S/AS01 pilot in western Kenya.
