The World Health Organization (WHO) has announced its recommendation of the widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine for children in malaria-endemic areas.

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Key points:

• RTS,S malaria vaccine recommended by WHO for children to protect them from malaria illness. The vaccine gives up to 50 percent protection against malaria.
• Recommendation based on results from a pilot program of over 800,000 children which found the vaccine to be safe, effective, well accepted and feasible to deliver.
• Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa.

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The recommendation means children in sub-Saharan Africa and other regions with moderate to high malaria transmission can be vaccinated to protect them from Plasmodium falciparum malaria.

Burnet Deputy Director and Head, Malaria Immunity and Vaccines Group, Professor James Beeson said this was a “historic moment”.

“Getting a vaccine is an incredibly important step. It is a really significant milestone that’s taken a long time to get to this point,” Professor Beeson said.

Professor Beeson said the WHO’s recommendation was based on pilot implementation of the RTS,S vaccine in Kenya, Ghana and Malawi, running since 2019, which showed vaccination was safe and effective at preventing severe illness in 800,000 children.

Image: RTS,S vaccination in Ghana. Source: WHO

“These larger studies were important to look at it practically, and assess if people would accept the vaccine and whether health services could roll it out,” he said.

The burden of malaria in Africa

Malaria remains a significant cause of illness and death in sub-Saharan Africa for children. More than 260,000 African children under the age of five years die from malaria each year, and hundreds of millions of people fall ill with the disease annually.

Burnet Postdoctoral Research Officer, Dr Liriye Kurtovic said significant progress has been made to reduce the burden of malaria since 2000, but this has stalled in recent years.

“The pilot implementation studies have shown that the vaccine does work, that people accept the vaccine, that it can be rolled out with other vaccines for children, and that it’s safe and effective.

“It will be a really important part of the strategy of driving down malaria in many parts of the world,” Dr Kurtovic said.

Image: The RTS,S vaccine has been well accepted by people in implementation trials in Ghana.

Key findings of the pilot implementation

The WHO recommends that the RTS,S vaccine should be provided in a schedule of four doses in children from five months of age, for the prevention of P. falciparum malaria in regions with moderate to high malaria transmission.

The WHO recommendation was based on data and insights generated from vaccinating children in Ghana, Kenya and Malawi, where malaria burden is high.

The trials were funded by Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria and Unitaid, who together contributed nearly USD$70 million.

Scaling up deployment of the vaccine will require significant additional resources, and is yet another reminder to ensure that we continue to appropriately fund the fight against ongoing epidemics in the face of COVID-19.

Findings include:

• The vaccine is feasible to deliver, even in the context of the COVID-19 pandemic
• The RTS,S vaccine increases equity in access to malaria prevention, by providing some benefit to children who are not sleeping under a bed net
• Strong safety profile
• No negative impact on uptake of bed nets or other childhood vaccinations
• Highly cost-effective in areas of moderate to high malaria transmission

Decades in development

Professor Beeson said the challenge of developing a malaria vaccine stemmed from the complexity of the malaria parasite organism, when compared to other pathogens like SARS-CoV-2 that causes COVID-19.

“People have developed vaccines for COVID-19 within an incredibly short time, whereas it’s taken 30 to 40 years to get to this point for malaria. It’s just been a lot harder to understand how to combat it with a vaccine,” he said.

Professor Beeson said in the context of the COVID-19 pandemic, which threatens to derail progress made towards eliminating malaria in many countries, the vaccine would be a crucial tool in ensuring progress is not lost.

“Adequate funding and resourcing is needed to ensure the vaccine is available for all children at high risk of malaria.”

Next steps for the RTS,S malaria vaccine will include funding decisions for broader roll-out, and malaria-endemic countries adopting the vaccine as part of their malaria control strategies.

Meanwhile research continues to understand how to refine or modify RTS,S to achieve higher protective levels, and longer lasting protection against malaria.

More information

Hear more from Professor James Beeson on the challenge of creating a malaria vaccine, and the threat COVID-19 poses to progress in eliminating malaria in Episode 8 of Burnet Institute’s podcast, How Science Matters.