Full Evidence Report on the RTS,S/AS01 Malaria Vaccine

Prepared by the Malaria Vaccine Implementation Programme (MVIP) Programme Advisory Group (PAG) in its capacity as the RTS,S SAGE/MPAG Working Group to support the joint review of the RTS,S/AS01 malaria vaccine by the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Group (MPAG).

In July 2015, based on the results from the Phase 3 trial of the malaria vaccine RTS,S/AS01, the European Medicines Agency (EMA) issued a positive scientific opinion on the vaccine under Article 58, concluding that the vaccine had an acceptable safety profile and that the benefits of the vaccine outweighed the risks. The Phase 3 trial of the RTS,S/AS01 malaria vaccine was conducted in two age-groups, with the first vaccine dose given either between the ages of 6 and 12 weeks or between 5 and 17 months. WHO issued a position paper summarizing the assessment and recommendations for this vaccine. The vaccine was efficacious, with the potential to provide important impact when added to current malaria control interventions. It was well-tolerated with a known association with febrile seizures.