RTS,S is the first malaria vaccine recommended for broad use by WHO.
In October 2021, the World Health Organization (WHO) recommended RTS,S/AS01 (RTS,S), the world's first malaria vaccine, for use in children at risk in sub-Saharan Africa and in other regions with moderate to high transmission of malaria caused by Plasmodium falciparum. The recommendation was informed by findings from pilot implementation of RTS,S through routine childhood immunization in areas of Ghana, Kenya, and Malawi, as well as other available evidence. The country-led and WHO-coordinated Malaria Vaccine Implementation Programme began in 2019.
The recommendation paved the way for the board of Gavi, the Vaccine Alliance (Gavi) to approve a malaria vaccination program to support the broader rollout of the vaccine in Gavi-eligible countries.
Key findings from the pilot program informed the recommendation for widespread use of the vaccine by WHO. Data and insights generated from two years of routine vaccination showed that delivery of the vaccine is feasible, and high uptake indicated strong community demand. The pilots showed that RTS,S helped to increase equity in access to malaria prevention in vaccinating areas. Pilot findings also reaffirm the vaccine's favorable safety profile, and in areas where it is being deployed, vaccination has substantially reduced the incidence of life-threatening severe malaria. Health economic data also shows that the vaccine has the potential for considerable public health impact, averting one death for every 200 fully vaccinated children. Additionally, results from a recent Phase 3 trial conducted in areas with highly seasonal malaria transmission show that using RTS,S in combination with seasonal malaria chemoprevention (SMC) could dramatically drive down the incidence of malaria in highly seasonal settings. The combination reduced malaria deaths and hospitalizations by 70 percent over SMC alone.
Efforts are now underway to help ensure the long-term, sustainable supply of the RTS,S vaccine, which includes plans for product transfer from the vaccine's developer, GSK, to Bharat Biotech of India. To learn more about the agreement, read the press release.
RTS,S was created in 1987 by scientists working in GSK laboratories. In early 2001, GSK and PATH—with support from the Bill & Melinda Gates Foundation—entered into a partnership to develop the vaccine for infants and young children living in malaria endemic regions in sub-Saharan Africa. Its efficacy was established in a Phase 3 trial that concluded in 2014.
RTS,S aims to trigger the immune system to defend against the first stages of malaria when the Plasmodium falciparum parasite enters the human host’s bloodstream through a mosquito bite and infects liver cells. The vaccine is designed to prevent the parasite from infecting the liver, where it can mature, multiply, reenter the bloodstream, and infect red blood cells, which can lead to disease symptoms. To learn more about RTS,S, read the fact sheet.