The World Health Organization (WHO) is recommending widespread use of a new malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The vaccine, known as the RTS,S/AS01 (RTS,S or Mosquirix), has been trialled in three countries in a pilot programme involving 800 000 children.
Though the vaccine only offers moderate protection against malaria, with 36% protection against malaria cases among children. One study estimated that even with realistic vaccine coverage, at a constraint of 30 million doses, 5.3 million cases and 24 000 deaths could be prevented among children under five, .
“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.”
This comes amid stagnation in progress in recent years against the deadly disease. In sub-Saharan Africa, malaria remains a primary cause of childhood illness and death. More than 260 000 African children under the age of five die from malaria annually.
“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.”
The WHO recommends that in the context of comprehensive malaria control the RTS,S malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by the WHO. This vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden.
The outcome of the pilots informed the recommendation based on data and insights generated from two years of vaccination in child health clinics in Ghana, Kenya and Malawi. Findings include:
- 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 pandemic.
- RTS,S enhances equity in access to malaria prevention.
- Data from the pilot programme showed that more than two-thirds of children in the 3 countries who are not sleeping under a bednet are benefitting from the RTS,S vaccine.
- Layering of tools results in over 90% of children benefitting from at least one preventive intervention (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 3 African countries – the vaccine has a favorable safety profile.
- No negative impact on uptake of bednets, other childhood vaccinations, or health seeking behavior for febrile illness. 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 febrile illness.
- 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 WHO-recommended malaria vaccine will include funding decisions 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.
The pilot programme was financed through collaboration between Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.
Source: WHO
