”Breakthrough” GSK malaria vaccine gets WHO approval for use in children in Africa

AFRICA – The World Health Organisation (WHO) has approved a ‘historic’ breakthrough vaccine against malaria that is set to save tens of thousands of lives in Africa and other developing countries.

Developed by pharmaceuticals major GSK, the RTS,S/AS01 vaccine has received a rare approval to help manage the world’s leading killer of children under five and vulnerable people such as pregnant mothers.

The recommendation by the WHO is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019,  providing an extra layer to the arsenal of interventions to the fight against malaria.

The world health body has therefore recommended the widespread use of the vaccine among children in sub-Saharan Africa and in other regions with moderate to high malaria transmission.

RTS,S is the first and only malaria vaccine to have been shown in pivotal long-term clinical trials to significantly reduce malaria in children and is the result of over 30 years of research led by GSK, with PATH and other partners. Past efforts to develop a malaria vaccine have failed to materialise.

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

Malaria is the No.1 cause of childhood illness and death in sub-Saharan Africa, where more than 260,000 children under the age of five die from the disease annually

Despite the widespread adoption and use of insect treated nets in many homes in Africa, in recent years, WHO and its partners have been reporting a stagnation in progress against the deadly disease.

“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 ever, 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.”

WHO reports that the vaccine had high impact in real-life childhood vaccination settings, with a significant reduction of 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.

The trial found that among children aged 5–17 months who received four doses of RTS,S, the vaccine prevented approximately 4 in 10 (39%) cases of malaria over 4 years of follow-up, and about 3 in 10 (29%) cases of severe malaria.

Significant reductions were also seen in overall hospital admissions as well as in admissions due to malaria or severe anaemia. In addition, the vaccine reduced the need for blood transfusions, which are required to treat life-threatening malaria anaemia, by 29%.

The WHO states that the vaccine is highly cost-effective, with modelling estimating that the vaccine is cost effective in areas of moderate to high malaria transmission, which are mainly in developing countries.

The recommendation from WHO follows the release of data in August 2020 from a study of 6,000 children by the London School Hygiene and Tropical Medicine – which added to the good news of the effectiveness of the vaccine in the prevention of malaria.

Published in the New England Journal of Medicine, the study showed that after three years, the combination of seasonal administration of antimalarials and RTS,S vaccination lowered clinical episodes of malaria and reduced hospital admissions from malaria by about 70% compared to the antimalarials alone, indicating that the impact of this vaccine can be increased to further reduce mortality, especially when combined with other recommended malaria control interventions.

Milestone for GSK and partners
GSK says that since the launch of the malaria vaccine pilots in 2019, more than 2.3 million vaccine doses have been administered, with community demand for the vaccine strong and evidence showing that the vaccine can effectively be delivered through the routine child immunization platform.

“GSK is proud that RTS,S, our ground-breaking malaria vaccine, developed over decades by our teams and partners, can now be made available to children in sub-Saharan Africa and other regions with moderate to high malaria transmission,’ said Thomas Breuer, Chief Global Health Officer, GSK.

“This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled. 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 says that in anticipation of the decision and wider roll-out beyond the pilot programmes in Malawi, Kenya and Ghana, it is working with partners to develop solutions to ensure equitable and long-term access to the RTS,S vaccine for the people who need it.

The pharma giant has also committed to donate up to 10 million doses for use in the pilots and to supply up to 15 million doses annually at no more than 5% above its production cost, following a recommendation and funding for wider use.

A Product Transfer deal, including technology transfer for long-term production, is also underway with India’s vaccines major Bharat Biotech, adds GSK, to hasten access to the vaccine to the developing world ravaged by the disease.

WHO’s recommendation
The world’s leading health body recommends that the RTS,S malaria vaccine be used for the prevention of malaria in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden in targeted counties with moderate to high incidences of malaria.

It adds that the vaccine is feasible, improves health and saves lives, with good and equitable coverage of of the vaccine seen through routine immunization systems, even with the COVID-19 pandemic, adding that more than two-thirds of children in the 3 countries who were not sleeping under a bednet during the study, also benefitted from the RTS,S vaccine.

“Layering the tools results in over 90% of children benefitting from at least one preventive intervention, whether it is the insecticide treated bednets or the malaria vaccine.”

WHO reveals that following the recommendation for malaria vaccine, it will seek funding 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.

Meanwhile, the pilot programme will continue in Ghana, Kenya and Malawi to understand the added value of the 4th vaccine dose and to measure longer-term impact on child deaths.

GAVI, the vaccine alliance has welcomed the historic announcement. It was part of the team of funders for the trials. “Today marks a historic achievement in our fight against malaria,” said Dr Seth Berkley, CEO of Gavi.

“The vaccine is an important additional tool to help control this disease alongside other interventions, such as bed nets, and especially when delivered seasonally in combination with antimalarial medication. I applaud the countries and communities who participated in the trials and pilots to provide this critical new tool for African countries.”

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