Immunization, Vaccines and Biologicals


Malaria is a preventable and treatable mosquito-borne illness. In 2013, 97 countries had ongoing malaria transmission. There were an estimated 207 million cases of malaria in 2012 (uncertainty range: 135 – 287 million) and an estimated 627 000 deaths (uncertainty range: 473 000 – 789 000). 90% of all malaria deaths occur in sub-Saharan Africa, and 77% occur in children under five. Between 2000 and 2012, an estimated 3.3 million lives were saved as a result of a scale-up of malaria interventions. 90%, or 3 million, of these lives saved are in the under-five age group, in sub-Saharan Africa.

There is currently no commercially available malaria vaccine, despite many decades of intense research and development effort. The most advanced vaccine candidate against Plasmodium falciparum is RTS,S/AS01. A large clinical trial with 15 460 children is ongoing in the following seven countries in sub-Saharan Africa: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and the United Republic of Tanzania.

The clinical trial data for WHO to consider making a policy recommendation is expected to be made available to WHO in late 2014. Depending on these full phase 3 results, the first WHO policy recommendations on use may occur in 2015. The policy timings depend on the outcome of the regulatory process with the European Medicines Agency.

Originally launched in 2006, The Malaria Vaccine Technology Roadmap has been updated in November 2013. The updated Roadmap represents a blueprint for second generation malaria vaccine development, including a new Vision, two new Strategic Goals and 13 priority activities, funding of which will be critical for successful development of a next generation of malaria vaccines by 2030.

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Last updated: 20 December 2013