23-Apr-2019: Malaria vaccine pilot launched in Malawi
WHO welcomes the Government of Malawi’s launch of the world’s first malaria vaccine in a landmark pilot programme. The country is the first of three in Africa in which the vaccine, known as RTS,S, will be made available to children up to 2 years of age; Ghana and Kenya will introduce the vaccine in the coming weeks.
Malaria remains one of the world’s leading killers, claiming the life of one child every two minutes. Most of these deaths are in Africa, where more than 250 000 children die from the disease every year. Children under 5 are at greatest risk of its life-threatening complications. Worldwide, malaria kills 435000 people a year, most of them children.
We have seen tremendous gains from bed nets and other measures to control malaria in the last 15 years, but progress has stalled and even reversed in some areas. We need new solutions to get the malaria response back on track, and this vaccine gives us a promising tool to get there. The malaria vaccine has the potential to save tens of thousands of children’s lives.
Thirty years in the making, RTS,S is the first, and to date the only, vaccine that has demonstrated it can significantly reduce malaria in children. In clinical trials, the vaccine was found to prevent approximately 4 in 10 malaria cases, including 3 in 10 cases of life-threatening severe malaria.
Malaria is a constant threat in the African communities where this vaccine will be given. The poorest children suffer the most and are at highest risk of death. We know the power of vaccines to prevent killer diseases and reach children, including those who may not have immediate access to the doctors, nurses and health facilities they need to save them when severe illness comes.
The pilot programme is designed to generate evidence and experience to inform WHO policy recommendations on the broader use of the RTS,S malaria vaccine. It will look at reductions in child deaths; vaccine uptake, including whether parents bring their children on time for the four required doses; and vaccine safety in the context of routine use.
The vaccine is a complementary malaria control tool – to be added to the core package of WHO-recommended measures for malaria prevention, including the routine use of insecticide-treated bed nets, indoor spraying with insecticides, and the timely use of malaria testing and treatment.
The WHO-coordinated pilot programme is a collaborative effort with ministries of health in Ghana, Kenya and Malawi and a range of in-country and international partners, including PATH, a non-profit organization, and GSK, the vaccine developer and manufacturer, which is donating up to 10 million vaccine doses for this pilot.
We look forward to the start of vaccination in Ghana, and then Kenya later this year. A vaccine for malaria is among many innovations needed to bring an end to this disease, and we proudly stand with all countries and our many partners in progressing towards a malaria-free world.
The malaria vaccine pilot aims to reach about 360,000 children per year across the three countries. Ministries of health will determine where the vaccine will be given; they will focus on areas with moderate-to-high malaria transmission, where the vaccine can have the greatest impact.
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. Additionally, WHO, PATH and GSK are providing in-kind contributions.
25-Apr-2017: Ghana, Kenya and Malawi to pilot malaria vaccine trial
The prospect of a malaria vaccine is great news. Information gathered in the pilot will help us make decisions on the wider use of this vaccine.
Announcement of the coordinated rollout comes as the international community marks World Malaria Day and the kick-off of World Immunization Week, 24-30 April, which celebrates the widespread use of vaccines that protect people against 26 diseases. Overall, vaccines prevent an estimated two to three million deaths each year, according to WHO.
The injectable RTS,S vaccine was developed to protect young children from the most deadly form of malaria caused by Plasmodium parasites. It will be assessed in the pilot programme as a complementary malaria control tool to potentially be added to the core package of WHO-recommended measures for malaria prevention. Combined with existing malaria interventions, such a vaccine would have the potential to save tens of thousands of lives in Africa.
Africa bears the greatest burden of malaria worldwide. Global efforts in the last 15 years have led to a 62 per cent reduction in malaria deaths between 2000 and 2015, yet approximately 429,000 people died of the disease in 2015 – the majority of them young children in Africa.
The WHO pilot programme will assess whether the vaccine’s protective effect in children aged 5 – 17 months old during Phase III testing can be replicated in real-life. Specifically, it will assess the feasibility of delivering the required four doses of RTS,S, the vaccine’s potential role in reducing childhood deaths and its safety in the context of routine use.
Pilot implementation strategy
The three countries selected to participate in the pilot were based on the criteria of high coverage of long-lasting insecticidal-treated nets; well-functioning malaria and immunisation programmes – a high malaria burden even after scale-up of LLINs; and participation in the Phase III RTS,S malaria vaccine trial. Each country will decide on the districts and regions to be included, with high-malaria-burden areas prioritized, as they are predicted to provide the broadest benefit. Information garnered from the pilot will help to inform later decisions about potential wider use of the vaccine.
The malaria vaccine will be administered via intramuscular injection and delivered through routine national immunization programmes. WHO is working with the three countries to facilitate regulatory authorization of the vaccine for use in the pilots through the African Vaccine Regulatory Forum. Regulatory support will also include measures to enable the appropriate safety monitoring of the vaccine and rigorous evaluation for eventual large scale use.
Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and the International Drug Purchase Facility UNITAID, are partnering to provide $49.2 million for the first phase of the pilot programme (2017-2020), which will be complemented in-kind by contributions from WHO and the British pharmaceutical company GSK .