October 6, 2021

RTS,S

WHO recommends the first malaria vaccine for widespread use

By the time WHO recommended it, the vaccine had already reached more than 900,000 children through ordinary clinics in three countries — over 2.3 million doses.

A recommendation, not a debut

On 6 October 2021 the World Health Organization recommended widespread use of the RTS,S/AS01 malaria vaccine among children in sub-Saharan Africa and other regions with moderate-to-high Plasmodium falciparum transmission, as part of comprehensive malaria control.

The recommended regimen is four doses, beginning at five months of age.

It was a policy recommendation rather than a first regulatory review or a first use: the pilots had begun in 2019, and the European Medicines Agency had issued a positive scientific opinion in 2015.

Two years of pilot evidence

The recommendation followed a joint evidence review by WHO's immunization and malaria advisory bodies, SAGE and MPAG, informed by two years of pilot implementation in Ghana, Kenya and Malawi.

Those pilots had reached more than 900,000 children since 2019 and delivered more than 2.3 million doses through routine child-health services.

WHO reported a 30% reduction in deadly severe malaria in the pilot settings.

What it did not authorize

This was not a blanket recommendation for every person or every malaria-endemic setting. It covered children in moderate-to-high P. falciparum transmission areas, and WHO placed vaccination explicitly inside comprehensive malaria control rather than in place of bed nets, diagnosis, treatment or other prevention.

Combining nets and vaccination meant more than 90% of pilot children benefited from at least one of those two tools, and more than two-thirds of vaccinated children who were not sleeping under a net still received a malaria-prevention intervention.

Worldwide rollout did not follow that day. Funding decisions and individual countries' adoption decisions still had to come, after roughly three decades of RTS,S research and development.

Sources

Researched 24 Aug 2026 6 sources not yet audited

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