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Gavi, Unitaid and the Global Fund Welcome WHO Recommendation for World's First Malaria Vaccine

06 October 2021

  • 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 – 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 impactful 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.

About Gavi, the Vaccine Alliance

Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation – over 888 million children – and prevented more than 15 million future deaths, helping to halve child mortality in 73 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology – from drones to biometrics – to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.

Gavi is a co-convener of COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, together with the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO). In its role Gavi is focused on procurement and delivery for COVAX: coordinating the design, implementation and administration of the COVAX Facility and the Gavi COVAX AMC and working with its Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery.

The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organizations that fund Gavi’s work here.

About Unitaid

Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is hosted by the World Health Organization.

About the Global Fund

The Global Fund is a worldwide movement to defeat HIV, TB and malaria and ensure a healthier, safer, more equitable future for all. We raise and invest US$4 billion a year to fight the deadliest infectious diseases, challenge the injustice which fuels them and strengthen health systems in more than 100 of the hardest hit countries. We unite world leaders, communities, civil society, health workers and the private sector to find solutions that have the most impact, and we take them to scale worldwide. Since 2002, the Global Fund has saved 44 million lives.

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