RTS,S/AS01 (Mosquirix^®) is a vaccine against malaria caused by Plasmodium falciparum. In a phase 3 trial, RTS,S/AS01 showed vaccine efficacy against clinical malaria, severe malaria and malaria hospitalization, with an acceptable safety and tolerability profile, in children aged 6 weeks to 17 months; the vaccine efficacy was greater in children than in infants and waned over time. In another phase 3 trial, RTS,S/AS01 was noninferior to seasonal malaria chemoprevention in children. WHO recommends a 4-dose schedule of RTS,S/AS01 for the prevention of P. falciparum malaria in children from 5 months of age living in regions with moderate to high malaria transmission, with an optional 5-dose schedule for areas with highly seasonal malaria transmission. First results from large pilot implementation in Africa show that RTS,S/AS01 has a favourable safety profile, increases equity in access to malaria prevention, is highly cost effective, can be delivered through routine national immunization programmes and substantially reduces severe malaria burden.