“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
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
- 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
- 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.
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.