Malaria Vaccine Green-Lit by the WHO

The World Health Organization (WHO) announced today it is recommending widespread use of GSK’s Mosquirix RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and other regions with moderate to high P. falciparum malaria transmission. 

The WHO 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.

To date, more than 2.3 million doses of the vaccine have been administered in African countries.

Mosquirix RTS,S/AS01e is a recombinant malaria vaccine that aims to trigger the immune system to defend against the first stages when the Plasmodium falciparum malaria parasite enters the human host’s bloodstream through a mosquito bite and infects liver cells.

Mosquirix does not provide complete protection against malaria caused by P. falciparum.

“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 in a video.

“Using this vaccine on top of existing  tools to prevent malaria could save tens of thousands of young lives each year.”

The WHO recommends that in the context of comprehensive malaria control, the RTS,S/AS01 malaria vaccine be used to prevent P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO.  

RTS,S/AS01 malaria vaccine should be provided in a schedule of four doses in children from 5 months of age to reduce malaria disease and burden.

Summary of key findings of the malaria vaccine pilots informed the recommendation based on data and insights generated from two years of vaccination in child health clinics:

• Feasible to deliver: Vaccine introduction is possible, improves health, and saves lives, with good and equitable coverage of RTS,S seen through routine immunization systems. This occurred even in the context of the COVID-19 pandemic.
• Data from the pilot program showed that more than two-thirds of children in the three countries who are not sleeping under a bednet benefit from the RTS,S vaccine.
• There is no negative impact on the uptake of bednets, other childhood vaccinations, or health-seeking behavior for febrile illness. In addition, in areas where the vaccine has been introduced, there has been no decrease in the use of insecticide-treated nets, uptake of other childhood vaccinations, or health-seeking behavior for febrile illness.
• High impact in real-life childhood vaccination settings: Significant reduction (30%) in deadly severe malaria, even when introduced in areas where insecticide-treated nets are widely used, and there is good access to diagnosis and treatment.
• Highly cost-effective: Modelling estimates that the vaccine is cost-effective in areas of moderate to high malaria transmission.

In recent years, WHO and its partners have reported stagnation in progress against the deadly disease. As a result, malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260,000 African children under the age of five die from malaria annually.

"For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Dr. Matshidiso Moeti, WHO Regional Director for Africa. 

“We have long hoped for an effective malaria vaccine, and now for the first time, we have such a vaccine recommended for widespread use.” 

“Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease, and we expect many more African children to be protected from malaria and grow into healthy adults.” 

The following steps for the WHO-recommended malaria vaccine 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.

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