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Shipments to African countries herald final steps toward broader vaccination against malaria
More than 330,000 doses of WHO-recommended RTS,S malaria vaccine arrived last night 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
Geneva/New York/Copenhagen, 22 November 2023 – Shipments of the world’s first WHO-recommended malaria vaccine, RTS,S, have begun with 331,200 doses landing last night 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 percent 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 immunization programmes, which should see first doses administered in Q1 2024.
Comprehensive preparations are needed to introduce any new vaccine into essential immunization programmes – such as training of health care workers, investing in infrastructure, technical capacity, vaccine storage, community engagement and demand; and sequencing and integrating roll-out 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 four 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 roll-out 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 is 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 roll out 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.
Quotes from countries and stakeholders
“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 immunization 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 life-saving 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.”
MEDIA CONTACTS
For interview requests and any other information, please contact:
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+41 79 711 55 54
msharafudeen@gavi.org
Matthew Grek, Gavi
+44 77 38 46 64 53
mgrek@gavi.org
Tess Ingram, UNICEF New York
tingram@unicef.org
Jenny Gamming, UNICEF Copenhagen
jgamming@unicef.org
WHO Press Office
mediainquiries@who.int
FAQs
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FAQs
Why are these shipments important?
These shipments represent the first time WHO-recommended malaria vaccine has been sent to countries outside of the pilot implementation countries, and they represent the final steps in preparation for scaled-up vaccination through routine immunisation programmes.
When will rollout begin?
These shipments represent one of the critical steps in preparation for broader rollout. First doses through routine immunisation will be administered beginning in Q1 2024.
What does country preparation involve?
In addition to the comprehensive preparations needed to introduce any new vaccine into routine immunisation programmes – such as training healthcare workers, investing in infrastructure, technical capacity, and vaccine storage, demand generation and community engagement, and sequencing and integrating rollout alongside the delivery of other interventions – the malaria vaccine requires careful planning to deliver a four-dose schedule. The malaria vaccine pilot programme provided crucial learnings on how to do this effectively.
How did we get here? Who played a role?
The first malaria vaccine recommended for use by WHO – RTS,S – was a breakthrough for science and public health, and decades in the making. Today’s historic step to make malaria vaccine more broadly available represents decades of advocacy from those most impacted by malaria, coupled with years of research and development by GSK and Africa-based scientists, public-private investments, as well as collaboration among global health partners:
- In 2013, the Gavi Board first considered an investment in malaria vaccination in lower-income countries, through Gavi’s vaccine investment strategy.
- In 2016, the Gavi Board approved funding for the Malaria Vaccine Implementation Programme, MVIP, to evaluate the public health use of the first malaria vaccine in routine immunisation programmes in selected (pilot) areas in Africa.
- Vaccine introductions in pilot areas were launched in 2019 in Ghana, Kenya and Malawi. The MVIP is coordinated by WHO working in collaboration with Ministries of Health, UNICEF, PATH, GSK and the funding partners Gavi, the Global Fund to Fight AIDS, Tuberculosis and Malaria and UNITAID.
- In 2019, the Gavi Board approved a plan to de-risk investment to ensure doses of RTS,S were produced and available ahead of WHO recommendation and prequalification, leading to an agreement between Gavi, GSK and MedAccess in 2021. This agreement helped fund the ongoing production of doses while evidence to support a broader policy decision was being collected.
- In October 2021, WHO recommended the RTS,S vaccine to prevent malaria in children, and shortly thereafter, the Gavi Board approved Gavi support for a routine malaria vaccination programme in December 2021, which guaranteed the organization would provide financing for vaccine doses and introduction activities in Gavi-eligible countries. Gavi, WHO, UNICEF and a range of other immunization and malaria partners began working with interested countries to support evidence-based national decision-making on vaccine introduction, provide guidance, technical assistance and coordination.
- In June 2022, Gavi opened the application window for countries who wished to rollout the vaccine through routine immunisation with Gavi support.
- In July 2022, anticipating an initially constrained malaria vaccine supply, WHO published a Framework for the allocation of limited malaria vaccine supply that was developed with expert advice. The Framework provides guidance on the global allocation of RTS,S between countries, based on ethical principles and considerations, until supply constraints are fully resolved.
- In August 2022, UNICEF signed a long-term agreement enabling procurement of RTS,S doses.
- Demand for malaria vaccines by countries in Africa has been unprecedented. At least 30 countries in Africa plan to introduce a malaria vaccine as part of their national malaria control plans. By April 2023, a record number of first applications had been received and reviewed by Gavi’s independent expert committee.
- In July 2023, 18 million doses of RTS,S, the first malaria vaccine, were allocated to 12 African countries for 2023-2025. The allocations were 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, until supply fully meets demand. 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.
- In October 2023, a second malaria vaccine, R21, was recommended by WHO. The R21 vaccine is currently undergoing the process of WHO prequalification, which is a prerequisite to international procurement of the vaccine in support of broader rollout.
- In the same month, UNICEF signed a long-term agreement to enable procurement of R21 doses post-WHO prequalification.
- In November 2023, first Gavi-funded doses arrived in countries and first shipments are now underway to non-pilot countries – signalling final steps towards broader vaccination against malaria on the African continent.
What is the malaria vaccine pilot programme?
- The Malaria Vaccine Implementation Programme, MVIP, was designed to evaluate the public health use of the RTS,S vaccine in Ghana, Kenya and Malawi. Initial findings from the pilot programme informed the first WHO recommendation for a malaria vaccine, RTS,S, in October 2021.
- Since 2019, over 2 million children at risk have been reached with the malaria vaccine across the 3 countries in Africa. The results of the evaluation of the MVIP after 4 years of vaccination show that the malaria vaccine has reduced all-cause deaths among children age-eligible for vaccination by 13%, and hospital admissions with severe malaria by 22%.
- The MVIP pilot programme will be completed in December 2023.
When will a second malaria vaccine be approved and rolled out?
A second malaria vaccine, R21, manufactured by Serum Institute of India (SII), is in the process of WHO prequalification – which enables international procurement and delivery. WHO prequalification convenes experts to evaluate the safety, efficacy and quality of vaccines. It also involves testing the vaccines and inspection of the manufacturing facilities. A decision is expected in the coming months.
Once WHO prequalification is completed, it is expected to that final steps to make doses available and ready for shipment will take a few months.
Are both malaria vaccines similar?
Both malaria vaccines are safe and effective. The two vaccines have not been tested in direct (head-tohead) comparison studies. However, given the similarity of the vaccines (in construct, target population and delivery), and available evidence, both malaria vaccines, when implemented broadly, are expected to have high public health impact.
WHO recommends both malaria vaccines should be provided in a schedule of 4 doses from around 5 months of age for the reduction of malaria disease and burden. The vaccine should be administered to children living in malaria endemic areas, prioritizing areas of moderate and high transmission.
How will countries decide which product to use?
Two malaria vaccines (RTS,S and R21) are recommended for use by WHO and available evidence indicates they are both safe and effective. The choice of product to be used in a country should be based on product characteristics and programmatic needs, vaccine supply availability and the likelihood of being able to scale up with a single product in the programme, and long-term affordability considerations.
Gavi, WHO, UNICEF and partners are currently in discussions with countries to understand the programmatic needs of each context, taking into the factors outlined below.
This means considerations for countries include the size of the target population for malaria vaccination compared to available volumes – and the ability to scale up without switching products. This means, for example, large countries are most likely to use R21, which is expected to be available in larger volumes, while smaller countries are likely to use RTS,S which is currently available in smaller volumes.
Additional considerations include affordability (which is relevant to countries in the later stages of transitioning out of Gavi support), vaccine presentation (R21 is fully liquid, while RTS,S does, although this is similar to other vaccines routinely administered such as measles/mumps/rubella vaccines), and R21 has slightly smaller cold chain storage implications, which may be relevant for countries that wish to rollout immediately but are concerned about current cold chain availability (before additional cold chain can be put into place).
How is malaria vaccination financed?
Malaria vaccination through routine programmes in lower-income countries is financed by Gavi, including the cost of doses and rollout. Per the Gavi model, countries also contribute a small portion of the cost of each dose, and this “co-financing” amount varies based on income level.
How much do malaria vaccines cost?
There is a difference between price of malaria vaccines and the cost countries pay.
The RTS,S vaccine costs a maximum of EUR 9.30 per dose (through 2025). The price reflects the fact that vaccine production is still scaling up and the supply is not yet in a steady state or benefitting from economies of scale. If cost of production decreases, this cost may reduce – with any refunds returned to countries and donors. It is also expected that the price of RTS,S will decrease once the technology transfer from GSK to BBIL is complete (expected currently sometime between 2028-2029). The R21 vaccine currently costs US$ 3.90 per dose for a two-dose presentation, and this decrease in future years as additional demand materializes.
However, due to these vaccines being rolled out through Gavi support, the amount countries pay is different from the procurement price. In December 2022, the Gavi Board approved an exceptional cofinancing approach that will be in place until 2027. Only countries at the final stages of transitioning out of Gavi support pay a direct proportion of price per dose (however, Gavi is working with this small subset of countries to ensure they can rollout with R21), while others pay a small amount per dose that is not product-specific (the lowest-income countries pay US$ 0.20 per dose).
Are there enough malaria vaccine doses available?
18 million doses of RTS,S manufactured by GSK have been contracted by UNICEF Supply Division from now until 2025, while the manufacturer executes technology transfer to Bharat Biotech (BBIL) – and additional volumes are expected to be available in the coming years. If R21 receives WHO prequalification, this adds a second critical source of supply, and it is expected that supply of malaria vaccine will meet demand.