Researchers and health professionals have been celebrating after the World Health Organization (WHO) approved the widespread use of the world’s first malaria vaccine on October 6th. Based on results from an ongoing pilot program in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019, the WHO is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. 

This recommendation means that the vaccine will soon be available – as an additional malaria control tool – to more children in the three countries taking part in the pilot program, and in other malaria-endemic regions of Africa as well.

More than 260,000 children under five die from malaria every year in sub-Saharan Africa. According to the WHO, this new development, which is decades in the making, could save tens of thousands of lives.

Health authorities are also keen to stress that this vaccine is a new weapon in the fight against malaria that needs to be used alongside other preventative measures, such as insecticide-treated bed nets and drugs that target the malaria parasite.

Key findings of the malaria vaccine pilot study 

Key findings of the pilot program informed the WHO’s recommendation, based on data and insights generated from two years of vaccination in child health clinics across Ghana, Kenya and Malawi, implemented under the leadership of the Ministries of Health of the three countries. Key highlights include:

• Feasible to deliver: Vaccine introduction is feasible, improves health and saves lives, with good and equitable coverage of RTS,S seen through routine immunization systems. This occurred even in the context of the COVID-19 pandemic.
• Reaching the unreached: RTS,S increases equity in access to malaria prevention.
  • Data from the pilot programme showed that more than two-thirds of children in the three countries who are not sleeping under a bednet are benefitting from the RTS,S vaccine.
  • Layering the tools results in over 90% of children benefiting from at least one preventive intervention (i.e. insecticide treated bednets or the malaria vaccine).
• Strong safety profile: To date, more than 2.3 million doses of the vaccine have been administered in three African countries – and the vaccine has a favorable safety profile. 
• No negative impact on uptake of bednets, other childhood vaccinations, or health seeking behavior for malaria-like symptoms: In areas where the vaccine has been introduced, there has been no decrease in the use of insecticide-treated nets, uptake of other childhood vaccinations or health seeking behavior for malaria- and fever-like symptoms.
• High impact in real-life childhood vaccination settings: Significant reduction (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.
• Highly cost-effective: Modelling estimates that the vaccine is cost effective in areas of moderate to high malaria transmission.

Next steps for the vaccine include funding decisions to support broader rollout, and decisions by country governments and health ministries regarding whether to adopt the vaccine. The Gavi Board is expected to consider financing of the vaccine later this year.

For more information, read the WHO’s press release here. More information on the pilot program is available here.