Malawi starts landmark trial of first ever child malaria vaccine

Malawi will begin immunising young children against malaria today, in a landmark large-scale pilot of the first vaccine to give partial protection against the disease, the World Health Organization said.

Although the vaccine protects only a third of children aged under two years from life-threatening or severe malaria, clinical trials have found those who are immunised are likely to have less severe cases of the disease. Earlier, smaller trials also showed the vaccine prevented four in 10 cases of malaria overall, in babies aged between five and 17 months.

Malaria remains one of the world’s leading killers, claiming the life of one child every two minutes, and there are signs the battle against the disease has slowed. Children under five are most at risk, particularly in Africa, where 250,000 die from malaria every year.

“We have seen tremendous gains from bed nets and other measures to control malaria in the last 15 years, but progress has stalled and even reversed in some areas” said WHO’s director-general, Dr Tedros Adhanom Ghebreyesus. “We need new solutions to get the malaria response back on track, and this vaccine gives us a promising tool to get there. The malaria vaccine has the potential to save tens of thousands of children’s lives.”

The “RTS,S” vaccine was 30 years in the making. The nearly 40% efficacy rate is not as high as vaccines for other diseases, but the WHO said RTS,S will add to the preventative measures already being used, such as bed nets and insecticides.

“Nobody is suggesting that this is a magic bullet,” said Dr David Schellenberg, scientific adviser to the WHO’s Global Malaria Programme, in an interview with the BBC.

“It may not sound like much but we’re talking about 40% reduction in severe malaria, which unfortunately still has high mortality even when you have good access to good treatment.”

The Malawi pilot, aimed at gathering evidence to inform WHO policy on broader use of the vaccine, is one of three large-scale trials. It will also be introduced in Ghana and Kenya in coming weeks. The trials will look at reductions in child deaths, safety and vaccine uptake – including whether parents bring their children in time for the required four doses. Concerns have previously been expressed over the practicality of the number and the timing of doses required – once a month for three months and then again at 18 months – which is out of sync with typical immunisation schedules in poorer countries.

“Malaria is a constant threat in the African communities where this vaccine will be given. The poorest children suffer the most and are at highest risk of death,” said Dr Matshidiso Moeti, WHO regional director for Africa.

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“We know the power of vaccines to prevent killer diseases and reach children, including those who may not have immediate access to the doctors, nurses and health facilities they need to save them when severe illness comes.

“This is a day to celebrate as we begin to learn more about what this tool can do to change the trajectory of malaria through childhood vaccination.”

The African countries were picked because they run large programmes to tackle malaria, including the use of bed nets, yet still have high numbers of cases.

The trials, co-ordinated by WHO, are a collaborative effort involving the ministries of health in Malawi, Kenya and Ghana and international partners including Path, a non-profit organisation, as well as GSK, the vaccine developer and manufacturer, which is donating up to 10 million vaccine doses. The campaign aims to reach 360,000 children in three countries.

Gavi, the Vaccine Alliance, the Global Fund to Fight Aids, Tuberculosis and Malaria, and Unitaid are providing just under $50m (£38m) to fund the first phase of the pilots in Malawi, Kenya and Ghana.