The World Health Organization (WHO) is recommending widespread use of the breakthrough RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high malaria transmission.
The recommendation is based on results from an ongoing pilot program in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019. Financing for the pilot program has been mobilised through a collaboration between three key global health funding bodies: Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.
RTS,S acts against Plasmodium falciparum, the most deadly malaria parasite globally and the most prevalent in Africa. Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa, with more than 260,000 African children under the age of five dying from malaria annually. Under development for 30 years, RTS,S is said to be the first and only vaccine that has demonstrated it can significantly reduce malaria in children.
Data from the pilot program, generated from two years of vaccination in child health clinics across Ghana, Kenya and Malawi, showed that more than two-thirds of children in the three countries who are not sleeping under an insecticide-treated bed net are benefiting from the RTS,S vaccine. There was also a significant reduction (30%) in deadly severe malaria even in areas where bed nets are widely used and there is good access to diagnosis and treatment. The vaccine has a favourable safety profile and has been found to be cost-effective in areas of moderate to high malaria transmission.
Based on these results, and the advice of two WHO global advisory bodies (one for immunisation and the other for malaria), the WHO recommends that the RTS,S malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission. The vaccine should be provided in a schedule of four doses in children from five months of age for the reduction of malaria disease and burden, the organisation says.
“The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”
The pilot program will continue in the three pilot countries to understand the added value of the fourth vaccine dose, and to measure longer-term impact on child deaths. Next steps will include funding decisions from the global health community for broader rollout, and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.
