The burden of malaria in the world has reduced over the last 15 years. This reduction has been attributed mainly to the rapid increase of key malaria control interventions including long-lasting mosquito nets that contain insecticides, spraying houses with insecticides and quick detection and treatment of malaria cases with drugs that work well. However, these gains are delicate and are threatened by parasites that are not killed by the drugs for malaria and mosquitos that are not killed by insecticides. Additional methods are urgently needed to add on to the current ones that are used to control malaria. In the past, vaccines have been shown to be one of the most affordable means of preventing diseases that are spread from one person to another and saving lives. Therefore, a malaria vaccine could be an important additional tool that could help the existing malaria control methods. GlaxoSmithKline (GSK) Biologicals has developed a malaria vaccine, RTS,S/AS01E or Mosquirix®, for protecting children against malaria in areas of sub-Saharan Africa where malaria is common. In a large study in young children in Africa, the vaccine was shown to prevent malaria to a certain extent, by reducing the number of times a child gets malaria, but not prevent it completely. The vaccine was assessed by the European Medicines Agency (EMA) and found to be useful. In October 2015, the World Health Organization (WHO) recommended that the vaccine be introduced and given to children 5–17 months of age, in parts of 3-5 sub-Saharan African countries in order to: 1) assess how easy it is to give the vaccine in a plan that includes a fourth does, 2) evaluate whether the vaccine reduces childhood deaths and 3) further check vaccine safety in the context of routine vaccination programs. The introduction of the vaccine called pilot implementation will be coordinated by the World Health Organization (WHO) in collaboration with the Ministry of Health and Program for Appropriate Technology in Health (PATH). As part of the pilot implementation, GSK will conduct studies which are typically done after a vaccine has been approved, to evaluate the safety of the vaccine by monitoring for adverse events (AEs) such as protocol-defined AEs of special interest (AESI), other AEs leading to hospitalization or death, meningitis as well as how well the vaccine will reduce the burden of malaria in vaccinated children compared to unvaccinated groups of children.

The reduction of global malaria burden over the last 15 years has been attributed mainly to the rapid scale-up of key interventions including long-lasting insecticidal nets (LLINs), indoor residual spraying (IRS) and prompt diagnosis and treatment with effective artemisinin-based combination therapies (ACTs). However, these gains are fragile and are threatened by emergence of parasite resistance to antimalarial drugs and vector resistance to insecticides. Additional tools are urgently needed to complement the current interventions. Historically, vaccines have been proven to be one of the most cost-effective means of preventing infectious diseases and saving lives. Therefore, a malaria vaccine could be an important additional tool that could complement the existing malaria control strategies. GlaxoSmithKline (GSK) Biologicals has developed a pre-erythrocytic Plasmodium falciparum malaria vaccine, RTS,S/AS01E, for protecting children against malaria in endemic areas of sub-Saharan Africa. In a large Phase III trial in young African children, the vaccine was shown to prevent malaria with a moderate level of efficacy. The vaccine received positive scientific opinion from the European Medicines Agency (EMA) and in October 2015, the World Health Organization (WHO) recommended pilot implementation of the vaccine in children 5–17 months of age, in parts of 3-5 sub-Saharan African countries to; 1) assess the programmatic feasibility of delivering the vaccine in a four-dose schedule, 2) evaluate vaccine impact on mortality and 3) further characterize vaccine safety in the context of routine immunization program. The pilot implementation will be coordinated by WHO in collaboration with the Ministry of Health and Program for Appropriate Technology in Health (PATH). As part of the pilot implementation, GSK will conduct post-approval Phase IV studies to evaluate the safety of the vaccine by monitoring for rare adverse events (AEs) such as protocol defined adverse events of special interest (AESI), other AEs leading to hospitalization or death, meningitis as well as the vaccine impact and effectiveness in vaccinated and unvaccinated cohorts.