Immunization, Vaccines and Biologicals


Malaria is a preventable and treatable mosquito-borne illness. According to the latest estimates from WHO, there were 214 million new cases of malaria and an estimated 438 000 malaria deaths worldwide in 2015, about 90% of which occurred in the African Region. Children under five are particularly susceptible to malaria illness, infection and death. In 2015, malaria killed an estimated 306 000 under-fives globally, including 292 000 children in the African Region.

There is currently no commercially available malaria vaccine. RTS,S/AS01 is the most advanced vaccine candidate against Plasmodium falciparum. A large Phase 3 clinical trial with 15 460 children was conducted 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 was reviewed by the European Medicines Agency and WHO. The European Medicines Agency issued a positive scientific opinion about the risk-benefit balance, upon agreement with the manufacturing company on further research plans as part of Phase 4 evaluation. WHO, upon review of the data, recommended pilot implementation studies to be conducted for further evaluation of a four dose schedule in children aged 5-17 months at first dose. WHO, the manufacturing company and other partners are currently working on the next steps.

Malaria vaccine development efforts are ongoing. 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: 1 February 2016