WHO Makes Historic Recommendation for Distribution of Malaria Vaccine

WHO endorsement for widespread use in Africa of the only vaccine against malaria comes at a time when progress in control of the disease has "stalled," the organization says.

The World Health Organization (WHO) on Wednesday endorsed wide distribution of the only approved vaccine against malaria to children across sub-Saharan Africa.

Following guidance of its global advisory bodies for immunization and malaria, WHO recommended broader use of the vaccine RTS,S (Mosquirix) in children in the sub-Sahara and other regions of Africa with significant transmission of the mosquito-borne disease.

Malaria remains a primary cause of morbidity and mortality in Africa, killing approximately 400 000 people in 2019. Children are at greatest risk—260 000 children younger than age 5 years died from the disease in 2019.

“This is a historic moment. 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 statement from WHO.

The vaccine is the result of more than 3 decades of research by manufacturer GlaxoSmithKline (GSK) and was first proven effective in 2015. WHO delayed its recommendation at the time based on the vaccine’s relatively low efficacy (32%), the requirement for 4 doses administered over 18 months, and the complexity of deploying the shots in a vast network of vulnerable health systems.

The new recommendation is based on a subsequent vaccine pilot program launched in 2019 in Ghana, Kenya, and Malawi that has reached more than 800 000 children with approximately 2.3 million doses administered. Program findings submitted to WHO showed that nearly 80% of eligible babies aged 6-months had received a first dose, with 41% coming in for a fourth dose by age 2 years. The report notes also that community demand for the vaccine is strong, and that delivery has been effective through the countries’ existing routine child immunization platform.

The research shows a reduction of 30% in severe cases of malaria among vaccinated children and that upwards of two-thirds of children in the 3 countries who are not protected by existing preventive methods (ie, bednetting) are benefitting from RTS,S vaccination, according to the WHO statement.

“Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year,” said Director General Ghebreyesus. In fact, pilot study data show that “layering” prevention tools (eg, insecticide-treated bednets, seasonal antimalarials) results in more than 90% of children deriving benefit from at least one intervention.

“This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled,” said Thomas Breuer, GSK chief global health officer, in a GSK statement.Both real world evidence and clinical trial data show that RTS,S, alongside other malaria prevention measures, has the potential to save hundreds of thousands of lives.”

GSK plans to transfer production of the vaccine to Bharat Biotech in India by the year 2028. Until then, the company has promised to deliver a minimum of 15 million doses each year.