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WHO recommends groundbreaking malaria vaccine for children at risk
Historic RTS,S/AS01 recommendation can reinvigorate the fight against malaria
6 October 2021 News release
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.
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.
GSK welcomes WHO recommendation for broad roll-out of its RTS,S/AS01e (RTS,S) malaria vaccine
Issued: 6 October, London UK
Based on the recommendation of its global advisory bodies for immunization and malaria, WHO has recommended the wider use of GSK’s RTS,S malaria vaccine in children living in sub-Saharan Africa and other regions with moderate to high malaria transmission.
Malaria vaccine pilot programmes in Ghana, Kenya and Malawi have shown high impact in real-life childhood vaccination settings, strong community demand and that RTS,S can be effectively delivered through routine child immunization platforms.
Recommendation follows shortly after new data show that RTS,S, in combination with seasonal administration of antimalarials, lowers clinical episodes of malaria, hospital admissions with severe malaria, and deaths by around 70%.
GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK’s RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO. RTS,S is the first and only malaria vaccine to have been shown in pivotal long-term clinical trials to significantly reduce malaria in children. The vaccine is the result of over 30 years of research led by GSK, with PATH and other partners.
Thomas Breuer, Chief Global Health Officer, GSK, said: “GSK is proud that RTS,S, our ground-breaking malaria vaccine, developed over decades by our teams and partners, can now be made available to children in sub-Saharan Africa and other regions with moderate to high malaria transmission. This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled. Both real world evidence and clinical trial data show that RTS,S, alongside other malaria prevention measures, has the potential to save hundreds of thousands of lives.”…
GSK believes that beating malaria is a shared responsibility and demands a range of tools – from accessible testing and treatment to preventative measures like a vaccine, complemented by bed nets as well as trained health workers to support prevention and treatment in the community.
GSK continues active research in malaria as part of its extensive Global Health research and development programme, and also works with partners such as Comic Relief and AMREF Health Africa to increase public health awareness, train health workers in underserved communities to better diagnose and treat malaria, and increase access to testing and medications.
GAVI, Unitaid and the Global Fund welcome WHO recommendation for world’s first malaria vaccine
WHO recommendation for wider use of the RTS,S malaria vaccine is largely based on data gathered during malaria vaccine pilots which took place in Kenya, Ghana and Malawi
Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria and global health agency Unitaid have together committed nearly US$ 70 million to fund the pilots
Following the WHO recommendation, global stakeholders, including Gavi, will consider whether and how to finance a new malaria vaccination programme
Geneva, 6 October 2021 – Gavi, the Vaccine Alliance, global health agency Unitaid and the Global Fund to Fight AIDS, Tuberculosis and Malaria welcome the WHO recommendation for wider routine use of the RTS,S malaria vaccine. The recommendation is based on data gathered through the Malaria Vaccine Implementation Programme (MVIP) which took place in Kenya, Ghana and Malawi over a two-year period and a clinical trial around the seasonal delivery of the vaccine in Mali and Burkina Faso, countries that experience high seasonal variation in malaria transmission.
The RTS,S pilots achieved and maintained good coverage levels, despite the COVID-19 pandemic. As of September 2021, over two years after the start of vaccinations, more than 2.3 million RTS,S doses have been administered across the three countries and more than 800,000 children have been reached with at least one dose of the vaccine. The pilots provided an opportunity to evaluate the feasibility of delivering four doses of RTS,S in real-life settings, where the vaccine was successfully rolled into existing immunisation programmes, widely accepted by both caregivers and healthcare workers, and reduced hospitalisations from severe malaria by 30%.
A further clinical trial led by the London School of Hygiene & Tropical Medicine assessed the impact of seasonal delivery of the malaria vaccine alongside seasonal malaria chemoprevention in Mali and Burkina Faso, countries that experience high seasonal variation of malaria transmission. The findings indicated a decrease of more than 70% in severe malaria cases in children when the vaccine was administered in combination with preventive antimalarials.
“Today marks a historic achievement in our fight against malaria,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “Malaria still kills over 250,000 children every year. The vaccine is an important additional tool to help control this disease alongside other interventions, such as bed nets, and especially when delivered seasonally in combination with antimalarial medication. I applaud the countries and communities who participated in the trials and pilots to provide this critical new tool for African countries.”
Ministries of Health led the implementation of the vaccine, which was delivered through routine immunisation programmes, with WHO playing a coordinating role, working in collaboration with GlaxoSmithKline, PATH and UNICEF. Following its investment of around US$ 700 million in the development of RTS,S, GSK has donated up to 10 million doses for the pilot programme. Gavi, the Global Fund and Unitaid have together committed nearly US$ 70 million to fund the pilot, which was designed to address several outstanding questions related to the public health use of the vaccine following the Phase 3 trial showing efficacy of RTS,S.
“We welcome this new tool in the fight against malaria,” said Peter Sands, Executive Director of the Global Fund. “In countries where the Global Fund invests, we have reduced malaria deaths by 45% since 2002 with testing, treatment and prevention tools such as mosquito nets. In the vaccine pilots, the RTS,S vaccine was most effective when used together with these existing tools. Significant additional resources will be necessary to enable wide deployment of the vaccine alongside other innovations, and as part of a sustained and comprehensive response in the countries that need it the most.”
“Even before the COVID-19 pandemic hit, progress against malaria was stalling,” said Dr Philippe Duneton, Executive Director of Unitaid. “This vaccine is a welcome new tool that, when used in combination with existing interventions like bed nets, has the potential to drive down malaria and extend protection to children across Africa. Pilot implementation has demonstrated how we can equitably reach children with this life-saving vaccine – now we need to ensure adequate and affordable supply to truly reignite the fight against malaria.”
The data collected through MVIP achieved similar rates of efficacy as seen in the Phase 3 clinical trial conducted from 2009 to 2014. The trial found that among children aged 5–17 months who received four doses of RTS,S, the vaccine prevented approximately 4 in 10 (39%) cases of malaria over 4 years of follow-up, and about 3 in 10 (29%) cases of severe malaria. Significant reductions were also seen in overall hospital admissions as well as in admissions due to malaria or severe anaemia. In addition, the vaccine reduced the need for blood transfusions, which are required to treat life-threatening malaria anaemia, by 29%.
Following the WHO recommendation, global stakeholders, including Gavi, will consider whether and how to finance a new malaria vaccination programme in sub-Saharan Africa. Ahead of this important decision, an innovative financing agreement between Gavi, MedAccess and GSK guarantees continued production of the RTS,S antigen for the malaria vaccine. The partnership aims to address vaccine supply challenges and reduce barriers to initial roll-out in the event that the Gavi Board makes a decision in favour of a Gavi-supported malaria vaccination programme.
The vaccine will be a complementary malaria control tool to be added to the core package of WHO-recommended measures for malaria prevention. This includes the routine use of insecticide-treated bed nets, indoor spraying with insecticides, malaria chemoprevention strategies, and the timely use of malaria testing and treatment.
PATH applauds WHO recommendation for broader use of first malaria vaccine
Vaccine shown to be cost-effective and trusted by caregivers and health care workers
October 6, 2021 by PATH