SNAP ANALYSIS Ghana approves second malaria vaccine – opening way to protecting children
Geneva, 13 April 2023 – Ghana – one of the first countries to vaccinate against malaria through the pilot malaria vaccine implementation programme (MVIP), supported by Gavi – has granted full national licensure to the R21/Matrix-M™ malaria vaccine, developed by the University of Oxford and manufactured and scaled up by the Serum Institute of India (SII). This second vaccine comes alongside the RTS,S vaccine, which was prequalified by the World Health Organization (WHO) in 2022 following a recommendation for its wider use in 2021. According to the WHO’s 2022 world malaria report, the disease killed 619,000 people in 2021 – with 96% of those deaths in the WHO African region, making malaria one of Africa’s biggest killers. Alongside existing interventions, this vaccine will help save more lives.
Ghana’s Food and Drugs Authority (FDA Ghana) has assessed trial data and approved the vaccine for use in children aged 5 to 36 months, the age group at highest risk of death from malaria. R21 has a three-dose primary series with a fourth (booster) dose a year later.
R21’s dossier for pre-qualification has been accepted for review by the WHO, and we expect that phase III results will be published soon. Should the WHO recommend the vaccine’s wider use, Gavi and UNICEF could move to begin funding and procuring doses immediately upon the vaccine’s pre-qualification. Gavi has already approved funding for a malaria vaccine programme and is ready to support adoption of R21 alongside RTS,S.
Gavi additionally welcomes SII’s announcement of a technology transfer deal to produce the vaccine in Ghana, upon completion of a factory in Accra – which will complement Gavi’s own work with partners including the African Union to support African vaccine manufacturing (more here).
Dr. Derrick Sim, Managing Director, Vaccine Markets & Health Security at Gavi, the Vaccine Alliance, commented on Ghana’s decision:
Ghana, as the first country to approve the R21 vaccine, shows how close the world is to having a second approved vaccine to fight malaria. Gavi is ready to provide funding for R21. What is important now is to ensure trial data are submitted for a timely SAGE evaluation and eventual WHO decision on prequalification. It is also crucial that SII honours public commitments to keep the cost of the vaccine to US$ 3 or less, to enable more people to be protected.
More than 1 million vulnerable children have been reached with the malaria vaccine through the MVIP pilots so far in 2019. Find out more about the malaria vaccine implementation programme here.
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For further comments, questions, or interviews: media@gavi.org
Notes for editors:
Dr Derrick Sim is a medical doctor and global expert in building healthy vaccine markets to ensure access in lower-income countries. Read more about Dr Sim here.
Gavi opened its first application window in July 2022 for support in rolling out the first ever malaria vaccine, to protect children against a disease that kills hundreds of thousands in Africa – read more here. Two more application windows have opened since. Gavi, WHO and partners expect to announce allocations of the RTS,S vaccine soon.
This follows on from a decision by the Board of Gavi, the Vaccine Alliance in December 2021 to approve an investment to support the malaria vaccine introduction, procurement and delivery for Gavi-eligible countries in sub-Saharan Africa in 2022-2025. An initial investment of US$ 155.7 million for 2022-2025 will initiate the implementation of this additional tool in the fight against malaria – read more here.
For expert insights and original content and stories from around the world, visit Gavi’s online digital platform VaccinesWork. You can find all of our articles on malaria in English here and in French here.
Pictures and other information related to the MVIP malaria pilot can be found here (credit “Gavi/2021/White Rhino Films-Lameck Orina”).
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 981 million children – and prevented more than 16.2 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, meningococcal and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation, above all the zero-dose children who have not received even a single vaccine shot. The Vaccine Alliance employs 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), the World Health Organization (WHO) and UNICEF. 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 organisations that fund Gavi’s work here.
