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The World Health Organization has approved a malaria vaccine made by Oxford university that has shown sustained protection in children, marking a turning point in the treatment of the disease.
Tedros Adhanom Ghebreyesus, the WHO’s director-general, said on Monday the health body was recommending a second vaccine for widespread use in preventing malaria in children.
“As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria,” Tedros said. “Now we have two.”
The approval of R21/Matrix-M adds a highly effective shot to the range of treatments for malaria. The WHO recommended the GSK-produced RTS,S/AS01, which Tedros said showed similar efficacy to the Oxford shot, for widespread use in 2021.
The latest vaccine will now be rolled out on a wide scale to the countries in sub-Saharan Africa where children are at the greatest risk from malaria. Oxford university has a manufacturing agreement with the Serum Institute of India (SII).
Tedros estimated the vaccine would cost $2-$4 per shot, which he described as “comparable to other malaria interventions and other childhood vaccines”.
R21’s approval would help meet “huge” demand for malaria shots, WHO officials said.
Eighteen countries had expressed interest in procuring the vaccine through Gavi, the global vaccine alliance, the highest-ever demand for any jab in the first year after applications were opened, said Mary Hamel, the WHO’s team lead for malaria vaccines.
Oxford university said SII had “already” established annual production capacity of 100mn doses, which would be doubled over the next two years.
“This scale of production is critical because vaccinating those at high risk of malaria will be important in stemming the spread of disease, as well as protecting the vaccinated,” it added on Monday.
The decision to approve the drug was based on input from the WHO’s strategic advisory group of experts on immunisation and its malaria policy advisory group. They reviewed evidence showing the shot reduced symptomatic cases by 75 per cent in the year after three doses of the vaccine, with a fourth dose shown to maintain protection.
The shot uses an adjuvant made by US drugmaker Novavax to boost its efficacy by enhancing the body’s immune response. Regulators in Ghana were first to approve the vaccine this year.
Malaria, which is caused by parasites transmitted by mosquitoes, remains a significant global health threat, especially in Africa, which in 2021 was home to 96 per cent of a global total of more than 600,000 deaths.
Children under five accounted for four-fifths of all deaths from malaria in the region. The disease is both preventable and curable, yet more than 240mn cases worldwide were recorded in 2021.
R21 targets the parasite in its early stages, just after it has come into contact with the human body. A study published last year showed the efficacy of a booster dose of the R21 vaccine was as high as 80 per cent.
“Demand for malaria vaccines is unprecedented; however, available supply of RTS,S is limited,” the WHO said. “The addition of R21 to the list of WHO-recommended malaria vaccines is expected to result in sufficient vaccine supply to benefit all children living in areas where malaria is a public health risk.”
Adrian Hill, director of Oxford university’s Jenner Institute, which developed the vaccine, said the jab was “cost-effective and affordable, ready for distribution in areas where it is needed most, with the potential to save hundreds of thousands of lives a year”.
