• More than 330,000 doses of WHO-recommended RTS,S malaria vaccine arrived this week in Cameroon – a historic step towards broader vaccination against one of the deadliest diseases for African children
• Malaria burden is the highest on the African continent, which accounted for approximately 95% of global malaria cases and 96% of related deaths in 2021
• With several African countries now finalizing rollout plans, an additional 1.7 million doses are set for delivery to Burkina Faso, Liberia, Niger and Sierra Leone in the coming weeks
• These shipments signal that malaria vaccination is moving out of its pilot phase, and lay the groundwork for countries to begin vaccinations through Gavi-supported routine immunization programmes in Q1 2024

Shipments of the world’s first WHO-recommended malaria vaccine, RTS,S, have begun with 331,200 doses landing this week in Yaoundé, Cameroon.

The delivery is the first to a country not previously involved in the malaria vaccine pilot programme and signals that scale-up of vaccination against malaria across the highest-risk areas on the African continent will begin shortly.

Nearly every minute, a child under five dies of malaria. In 2021, there were 247 million malaria cases globally, which led to 619,000 deaths.

Of these deaths, 77 per cent were children under 5 years of age, mostly in Africa. Malaria burden is the highest on the African continent, which accounts for approximately 95% of global malaria cases and 96% of related deaths in 2021.

A further 1.7 million doses of the RTS,S vaccine are expected to arrive in Burkina Faso, Liberia, Niger and Sierra Leone in the coming weeks, with additional African countries set to receive doses in the months ahead.

This reflects the fact that several countries are now in the final stage of preparations for malaria vaccine introduction into routine immunisation programmes, which should see first doses administered in Q1 2024.

Comprehensive preparations are needed to introduce any new vaccine into essential immunisation programmes – such as training of healthcare workers, investing in infrastructure, technical capacity, vaccine storage, community engagement and demand, and sequencing and integrating rollout alongside the delivery of other vaccines and health interventions.

Delivering the malaria vaccine has the added challenge of a four-dose schedule which requires careful planning to effectively deliver.

Since 2019, Ghana, Kenya, and Malawi have been administering the vaccine in a schedule of 4 doses from around 5 months of age in selected districts as part of the pilot programme, known as the Malaria Vaccine Implementation Programme (MVIP).

More than 2 million children have been reached with the malaria vaccine in the three African countries through MVIP – resulting in a remarkable 13% drop in all-cause mortality in children age-eligible to receive the vaccine, and substantial reductions in severe malaria illness and hospitalizations.

Other key findings from the pilot programme show that vaccine uptake is high, with no reduction in use of other malaria prevention measures or uptake of other vaccines.

MVIP is coordinated by WHO in collaboration with UNICEF and other partners, and funded by Gavi, the Global Fund, and UNITAID, with donated doses from GSK, the manufacturer of the RTS,S vaccine.

The data from the pilot have shown the impact and safety of the RTS,S vaccine and provided important evidence on vaccine acceptability and uptake that helped inform the recent WHO recommendation of a second malaria vaccine – R21, manufactured by the Serum Institute of India (SII). Results of a phase 3 trial for R21 showed that the vaccine has a good safety profile in the clinical trial setting and reduces malaria in children. It is expected that, like RTS,S, when R21 is implemented it will have similar high public health impact.

The choice of which vaccine to be used in a country should be based on programmatic characteristics, vaccine supply, and affordability.

The R21 vaccine is currently under review by WHO for prequalification. The availability of two malaria vaccines is expected to increase supply to meet the high demand from African countries and result in sufficient vaccine doses to benefit all children living in areas where malaria is a public health risk. In preparation for scaled-up vaccination, Gavi, WHO, UNICEF and partners are working with countries that have expressed interest and/or have confirmed rollout plans on the next steps.

These developments mean that broad implementation of malaria vaccination in endemic regions has the potential to be a gamechanger for malaria control efforts, and could save tens of thousands of lives each year. However, malaria vaccines are not a standalone solution.

They should be introduced in the context of the WHO-recommended package of malaria control measures which include insecticide-treated nets, indoor residual spraying, intermittent preventive treatment in pregnant women, antimalarials, effective case management, and treatment, all of which have helped to reduce malaria-related deaths since 2000.

Importantly, the MVIP showed that delivering vaccines alongside non-vaccine interventions can reinforce the uptake of other vaccines and the use of insecticide treated nets, and overall boost access to malaria prevention measures.

“The world needs good news – and this a good news story,” said David Marlow, CEO of Gavi, the Vaccine Alliance. “Gavi is proud that our Alliance of stakeholders, with African countries at the forefront, took the decision to invest in the malaria vaccine as a public health priority, and that this support has played a part in the availability of a new tool that can save the lives of thousands of children each year. We are excited to rollout this historic vaccine through Gavi programmes and work with partners to ensure it is delivered alongside other vital measures.”

“This could be a real gamechanger in our fight against malaria,” said UNICEF Executive Director Catherine Russell. “Introducing vaccines is like adding a star player to the pitch. With this long-anticipated step, spearheaded by African leaders, we are entering a new era in immunization and malaria control, hopefully saving the lives of hundreds of thousands of children every year.”

“This is another breakthrough moment for malaria vaccines and malaria control, and a ray of light in a dark time for so many vulnerable children in the world. The delivery of malaria vaccines to new countries across Africa will offer life-saving protection to millions of children at risk of malaria,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “But we must not stop here. Together, we must find the will and the resources to bring malaria vaccines to scale, so more children can live longer, healthier lives.”

“This is a significant advancement towards scaling up malaria vaccination in the region. The vaccine, which protects children from the severe forms of the disease, is a vital addition to the existing set of malaria prevention tools and will help bolster our efforts to reverse the rising trend in cases and further reduce deaths,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.

How some countries and stakeholders reacted:

“The arrival of the RTS,S/AS01 malaria vaccine in Burkina Faso marks a historic milestone in our efforts to combat malaria, which remains a major public health threat. Malaria is in fact the primary cause for consultations, hospitalization and death in our health facilities. Children under 5 pay the heaviest price. We are hopeful that the introduction of this vaccine into routine immunisation for children aged 0 to 23 months will have the potential to reduce the burden of this disease and save many lives,” said Dr Robert Lucien Jean-Claude Kargougou, Burkina Faso’s Minister of Health and Public Hygiene.

“We are committed to ensuring that the vaccine reaches eligible children, and we encourage all parents to take advantage of this life-saving intervention.” “The government remains committed to strengthening other malaria prevention and control measures”. “The arrival of the vaccines marks a historic step in our efforts to control malaria, which remains a major public health threat in the country. We’re grateful for the support of our partners with whom we’re committed to working to ensure that the vaccines reach the children and protect them from this deadly disease,” said Hon Dr Malachie Manaouda, Minister of Public Health of Cameroon. “As we vaccinate children, the government also remains committed to strengthening other prevention and control measures so that we can lower the huge burden of malaria.”

“The introduction of the RTS,S/AS01 malaria vaccine in Liberia marks a significant milestone in our efforts to combat malaria which is the leading cause of infant and under five mortality. This vaccine has the potential to save many lives and reduce the burden of this disease on our population,” said Hon Dr Wilhemina Jallah, Minister of Health of Liberia. “We are committed to ensuring that the vaccine reaches those who need it the most, and we encourage all parents of eligible children to take advantage of this life-saving intervention.”

“Today’s announcement is welcome news given that malaria remains a primary cause of childhood illness and death in sub-Saharan Africa,” said Peter Sands, Executive Director of the Global Fund. “Using this vaccine, appropriately prioritized in the context of existing tools, could help prevent malaria and save tens of thousands of young lives each year.”

“I am thrilled that the RTS,S vaccine, which is the result of so many years of work by PATH, GSK, and African partners, has arrived in Cameroon and will soon reach even more children at risk of malaria,” said Nikolaj Gilbert, President and CEO of PATH. “All of us at PATH appreciate the efforts by Gavi, UNICEF, and WHO to accelerate access to this life-saving vaccine.”

“As the scale up of the world’s first malaria vaccine begins, the U.S. President’s Malaria Initiative congratulates the Gavi Secretariat and Ministries of Health throughout Africa,” said Dr. David Walton, U.S. Global Malaria Coordinator. “This moment has been decades in the making and the U.S. has supported malaria vaccine development for decades. To maximize the benefit of this lifesaving tool, we will enthusiastically continue our partnerships with Ministries of Health and national, regional, and global partners to achieve a world in which no child dies from a mosquito bite.”

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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.