The World Health Organization (WHO) has approved the use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high transmission of the malaria parasite, Plasmodium falciparum.
The first-generation malaria vaccine previously named Mosquirix has demonstrated modest efficacy against malaria illness, especially for children in high-transmission areas. It was created in 1987 and began pilot implementation in endemic countries in 2019.
The WHO approval for use in children announced on Wednesday is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800,000 children since it began in 2019.
According to WHO, the malaria vaccine acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa.
In the recommendation note, WHO stated that, “in the context of comprehensive malaria control the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO,” adding that RTS,S/AS01 malaria 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.
Their recommendation is based on the advice of two WHO global advisory bodies, one for immunization and the other for malaria. It was also informed by key findings of the pilots based on data and insights generated from two years of vaccination in child health clinics in the three pilot countries, implemented under the leadership of the Ministries of Health of Ghana, Kenya and Malawi.
Some of the findings that informed the approval by WHO include the fact that the vaccine introduction is feasible. It was found that, with good and equitable coverage of RTS,S through routine immunization systems, health could be improved and lives save.
It was also found that RTS,S increases equity in access to malaria prevention, as data from the pilot programme showed that more than two-thirds of children in the three countries who are not sleeping under a bed net are benefitting from the RTS,S vaccine.
A major positive from the pilot is the strong safety profile of the malaria vaccine. To date, more than 2.3 million doses of the vaccine have been administered in the African countries, and it has not had negative impact on uptake of bed nets, other childhood vaccinations, or health seeking behavior for similar illness.
It has also been found to significantly reduce (30%) cases of deadly severe malaria.
WHO Director-General, Dr Tedros Adhanom Ghebreyesus said, “This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”
Malaria is a primary cause of childhood illness and death in sub-Saharan Africa, killing more than 260, 000 African children under the age of five die annually.
WHO Regional Director for Africa Dr Matshidiso Moeti, said “For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering. 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.”
Meanwhile, the Malaria Vaccine Implementation Programme is currently generating evidence and experience on the feasibility, impact and safety of the RTS,S malaria vaccine in real-life, routine settings in selected areas of Ghana, Kenya and Malawi.
According to the WHO, the next step 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 RTS,S malaria vaccine is the result of 30 years of research and development by GSK and through a partnership with PATH, with support from a network of African research centres.