• Malaria Vaccine Implementation Programme countries Ghana, Kenya and Malawi will receive doses to continue vaccinations in pilot areas

• Allocations were also made for new introductions in Benin, Burkina Faso, Burundi, Cameroon, Democratic Republic of the Congo, Liberia, Niger, Sierra Leone and Uganda

Twelve countries across different regions in Africa are set to receive 18 million doses of the first-ever malaria vaccine over the next two years. The roll out is a critical step forward in the fight against one of the leading causes of death in the continent.

The allocations have been determined through the application of the principles outlined in the Framework for allocation of limited malaria vaccine supply that prioritizes those doses to areas of highest need, where the risk of malaria illness and death among children are highest.

Since 2019, Ghana, Kenya and Malawi have been delivering the malaria vaccine through the Malaria Vaccine Implementation Programme (MVIP), coordinated by WHO and funded by Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Unitaid.

The RTS,S/AS01 vaccine has been administered to more than 1.7 million children in Ghana, Kenya and Malawi since 2019 and has been shown to be safe and effective, resulting in a substantial reduction in severe malaria and a fall in child deaths. At least 28 African countries have expressed interest in receiving the malaria vaccine.

In addition to Ghana, Kenya and Malawi, the initial 18 million dose allocation will enable nine more countries, including Benin, Burkina Faso, Burundi, Cameroon, the Democratic Republic of the Congo, Liberia, Niger, Sierra Leone and Uganda, to introduce the vaccine into their routine immunisation programmes for the first time.

This allocation round makes use of the supply of vaccine doses available to Gavi, Vaccine Alliance via UNICEF. The first doses of the vaccine are expected to arrive in countries during the last quarter of 2023, with countries starting to roll them out by early 2024.

“This vaccine has the potential to be very impactful in the fight against malaria, and when broadly deployed alongside other interventions, it can prevent tens of thousands of future deaths every year,”

said Thabani Maphosa, Managing Director of Country Programmes Delivery at Gavi, the Vaccine Alliance.

“While we work with manufacturers to help ramp up supply, we need to make sure the doses that we do have are used as effectively as possible, which means applying all the learnings from our pilot programmes as we broaden out to a new total of 12 countries.”

Malaria remains one of Africa’s deadliest diseases, killing nearly half a million children each year under the age of 5, and accounting for approximately 95% of global malaria cases and 96% of deaths in 2021.

“Nearly every minute, a child under 5 years old dies of malaria,”

said UNICEF Associate Director of Immunization Ephrem T Lemango.

“For a long time, these deaths have been preventable and treatable; but the roll-out of this vaccine will give children, especially in Africa, an even better chance at surviving. As supply increases, we hope even more children can benefit from this life-saving advancement.”

“The malaria vaccine is a breakthrough to improve child health and child survival; and families and communities, rightly, want this vaccine for their children. This first allocation of malaria vaccine doses is prioritised for children at highest risk of dying of malaria,” said

Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals.

“The high demand for the vaccine and the strong reach of childhood immunisation will increase equity in access to malaria prevention and save many young lives. We will work tirelessly to increase supply until all children at risk have access.”

Given the limited supply in the first years of the roll-out of this new vaccine, in 2022 WHO convened expert advisors, primarily from Africa – where the burden of malaria is greatest – to support the development of a Framework for allocation of limited malaria vaccine supply, to guide where initial limited doses would be allocated. The Framework is based on ethical principles on a foundation of solidarity; and it proposes that vaccine allocation begin in areas of greatest need. 

The Framework implementation group that applied the framework principles included representatives of the Africa Centres for Disease Control and Prevention (Africa CDC), UNICEF, WHO and the Gavi Secretariat, as well as representatives of civil society and independent advisors. The group’s recommendations were reviewed and endorsed by the Senior Leadership Endorsement Group of Gavi, WHO and UNICEF (for more, see First malaria vaccine supply allocations: explanation of process and outcomes).

Annual global demand for malaria vaccines is estimated at 40–60 million doses by 2026 alone, growing to 80–100 million doses each year by 2030. In addition to the RTS,S/AS01 vaccine, developed and produced by GSK, and in the future supplied by Bharat Biotech, it is expected that a second vaccine, R21/Matrix-M, developed by Oxford University and manufactured by Serum Institute of India (SII), could also be prequalified by WHO soon. Gavi has recently outlined its roadmap to support increasing supply to meet demand.

This international support of nearly US$160 million from 2022-2025 will facilitate increased vaccine access to children at high risk of illness and death from malaria, starting with Ghana, Kenya and Malawi, the three African countries that began pilot introduction of the vaccine in 2019, and then expanding to other eligible endemic countries.

Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. In 2020, nearly half a million African children died from malaria – or 1 child died of malaria every minute.

Since the world’s first malaria vaccine was introduced in 2019, it has been well accepted in African communities after a relatively short period of time.

Demand is high even in the context of COVID-19: vaccination performance for the first dose is reaching between 73% to over 90% coverage, depending on the country, with no major disruptions during the pandemic. To date, about 1.3 million children have benefitted from the vaccine in the three African pilot countries.

“Gavi’s new funding opportunity brings us one step closer to reaching millions more children across Africa with the lifesaving RTS,S malaria vaccine,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Throughout the pandemic, when routine health services faced myriad challenges, parents and caregivers diligently brought their children to clinics and health posts to get the malaria vaccine. They know all too well that lives are being lost to malaria every day and are eager to protect their children from this deadly disease.”

Following WHO’s recommendation in October 2021 for widespread use of the RTS,S malaria vaccine among children in regions with moderate to high Plasmodium falciparum malaria transmission, a number of malaria-endemic countries have expressed interest in adopting the vaccine and are expected to apply for Gavi support to introduce the vaccine. The RTS,S vaccine works specifically against Plasmodium falciparum, which is the deadliest malaria parasite and the most prevalent on the African continent. Where the vaccine has been introduced, there has been a substantial drop in children being hospitalized with severe malaria and a drop in child deaths in the age group that is eligible for the vaccine.

Gavi has indicated that the first application deadline in September 2022 is reserved for countries currently piloting the vaccine and for which continuity of the vaccine programme is a priority. A second window open to other eligible malaria-endemic countries will close in January 2023. Countries can already submit expressions of interest during the first funding window for inclusion in this round.

“Malaria has devastated communities for far too long in Africa. We know that initially, supply, will not meet demand, nevertheless, we look forward to working with countries and our partners to introduce and scale this new tool in our fight against malaria, which could save the lives of thousands of children across the continent,” said Thabani Maphosa, Managing Director of Country Programmes at Gavi. “Gavi is proud to support this vaccine, and we hope this is just the beginning of a broader rollout that will see populations across the continent increasingly protected against this deadly disease.”

Like with many new vaccines, the supply of the malaria vaccine is limited as vaccine production ramps up.

“The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. It is projected that – at scale – using this vaccine could save tens of thousands of young lives each year, but we will need an increased supply of the vaccine so Africa can reap the benefits of this additional tool for malaria prevention,” said Professor Rose Leke, a malaria disease expert from the University of Yaounde in Cameroon, and co-chair of the expert group that advised WHO on a framework to allocate the currently limited malaria vaccine supply.

Over the next few years, the supply of the RTS,S malaria vaccine will be insufficient to meet the needs of over 25 million children born each year in areas where the vaccine is recommended, according to a WHO-commissioned global market study.

Should a second malaria vaccine complete clinical development successfully and be approved for use, the period of constrained supply could be shorter. The demand is estimated to range from 80 to 100 million doses annually.   

In response to the supply situation, WHO has developed, with expert advice, a framework to guide vaccine allocation decisions at global and country levels that ensures children at highest risk across endemic countries are prioritized to receive the vaccine.

The framework also aims to ensure that childhood vaccination services started in the three pilot countries continue without disruption, until supply fully meets demand.

“Now is the time for African countries and communities to call out their interest – to donors, health leaders and manufacturers – in early access to this vaccine. Lives are at stake, every day,” added Dr Moeti. “This situation underlines once again why expanded local production of vaccines is essential for meeting health needs in Africa. We’ve seen encouraging first steps in that direction in recent months, and we are committed to supporting further efforts to expand vaccine production in Africa.”

WHO, Gavi and partners are working to accelerate RTS,S supply by exploring approaches to increase manufacturing capacity, market-shaping and facilitating the development of other first-generation and next-generation malaria vaccines.

Dr Moeti spoke during a virtual press conference today. She was joined by Mr Maphosa and Professor Leke.

Also on hand from WHO Regional Office for Africa to respond to questions were: Dr Akpaka Kalu, Team Lead, Strategic planning and Policy, Communicable and Noncommunicable diseases Cluster, Dr Opeayo Ogundiran, Epidemiology Pillar Lead for the Regional COVID-19 Response; Dr Phionah Atuhebwe, Medical Officer, New Vaccines and Dr Solomon Woldetsadik, Emergency Response Officer.