WHO recommends groundbreaking malaria vaccine for children at risk
Historic RTS,S/AS01 recommendation can reinvigorate the fight against malaria
The World Health Organization (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. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019.
“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 remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260 000 African children under the age of five die from malaria annually.
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 recommendation for the RTS,S malaria vaccine
Based on the advice of two WHO global advisory bodies, one for immunization and the other for malaria, the Organization recommends that:
WHO recommends 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. 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.
Summary of key findings of the malaria vaccine pilots
Key findings of the pilots informed the recommendation 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. Findings 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 3 countries who are not sleeping under a bednet are benefitting from the RTS,S vaccine.
- Layering the 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.
Financial support
Financing for the pilot programme has been mobilized through an unprecedented collaboration among three key global health funding bodies: Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.
Note to editors:
- The malaria vaccine, RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa.
- The Malaria Vaccine Implementation Programme is 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.
- Pilot malaria vaccine introductions are led by the Ministries of Health of Ghana, Kenya and Malawi.
- The pilot programme will continue in the 3 pilot countries to understand the added value of the 4th vaccine dose, and to measure longer-term impact on child deaths.
- The Malaria Vaccine Implementation Programme is coordinated by WHO and supported by in-country and international partners, including PATH, UNICEF and GSK, which is donating up to 10 million doses of the vaccine for the pilot.
- 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.
- The Bill & Melinda Gates Foundation provided catalytic funding for late-stage development of RTS,S between 2001 and 2015.
WHO greenlights the world's first malaria vaccine — but it's not a perfect shot
The world's arsenal against malaria just got a fancy new bazooka. But it's not the easiest weapon to deploy, it only hits its target 30 to 40% of the time, and it's not yet clear who's going to pay for it.
The weapon in question is the RTS,S vaccine from GlaxoSmithKline, which on Wednesday got the green light from the World Health Organization for widespread use.
This is not only the first authorized malaria vaccine, it's also the first vaccine ever approved for use against a parasitic disease in humans.
The recommendation comes after RTS,S showed positive results in a pilot program in Ghana, Kenya and Malawi. The vaccine cut malaria cases by 40% and reduced hospitalizations of the potentially deadly disease by nearly a third.
Tedros Adhanom Ghebreyesus, WHO's director general, called the approval of RTS,S a historic moment.
"The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control," he said.
RTS,S won regulatory approval from the European Medicines Agency back in 2015 but WHO wanted to wait for the results of this latest pilot program before recommending it for use in countries with moderate to high levels of malaria transmission. The expectation is that it will be used primarily in sub-Saharan Africa, where the mosquito-borne disease is one of the top killers of children, claiming nearly a quarter of a million lives each year.
"This opens up a whole new avenue for malaria control," says David Schellenberg of WHO's Global Malaria Program, who says that RTS,S gives health officials a new powerful tool to fight the disease.
Combined with bed nets, spraying for mosquitoes and new drugs, the vaccine could have a major impact in places where malaria remains a chronic problem, Schellenberg says.
Matshidiso Moeti, WHO regional director for Africa, says she's delighted by the new recommendation.
"For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering," Moeti said during the announcement. Nearly 95% of all malaria cases globally occur in Africa.
"Now for the first time ever, we have a [malaria] vaccine recommended for widespread use. Today's recommendation, therefore, offers a glimmer of hope for the continent," she said.
But the vaccine won't be rolling out across Africa tomorrow. It's still unclear where the money to purchase doses will come from. Also it's a complicated vaccination to administer, requiring four injections spread out over the first two years of a child's life. And given that it only prevents malaria 30 to 40% of the time, this vaccine is far less effective than health officials had hoped.
Pedro Alonso, head of WHO's Global Malaria Program, says part of the problem is that malaria is a complicated disease. "This is a parasitic disease," he points out. The parasite life cycle plays out in multiple stages in different parts of the human body and in the mosquito hosts. "This is orders of magnitude more complex in terms of the biology of the causative organism [than a virus]," he says.
Decades of research have gone into developing RTS,S. Alonso would love to see a vaccine that's 95% effective in preventing malaria but says the scientific community is still a long way off from developing that: "But what we do have right now is a vaccine that can be deployed, that is accepted, that is safe and that can have a massive impact in terms of lives saved and episodes of malaria averted."
Countries that decide to move forward with administering RTS,S still need to figure out how to pay for it and how to integrate it into their childhood immunization schedules. GlaxoSmithKline had donated 10 million doses of the vaccine for pilot programs and has now pledged to deliver 15 million doses a year at a price of 5% above cost. Eventually GSK says it plans to transfer production to a producer in India.
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