Kampala — In response to high demand for the first-ever malaria vaccine, Uganda has been listed among 12 countries in Africa that will be allocated a total of 18 million doses of RTS,S/AS01 for the 2023-2025 period.
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.
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.
This vaccine is the result of several decades of research and development, supported through public-private partnerships and significant contributions by African scientists and communities. Thanks to an innovative financing agreement between Gavi, the Vaccine Alliance, GlaxoSmithKline (GSK) and MedAccess, vaccine doses are available to initiate the Gavi-supported malaria vaccine roll-out.
"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."
High demand
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."
However, current estimates suggest that the initial supply of the vaccine is insufficient to meet the needs of over 25 million children born each year in regions with moderate to high malaria transmission.
Demand forecast scenarios suggest that this may translate into a long-term need of more than 100 million doses of malaria vaccine per year (assuming a 4-dose schedule although some countries may decide on a 5-dose strategy).
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. 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.
However, supply of the vaccine is expected to be insufficient to meet the need in the initial years. A recent Global Malaria Vaccine Market Study, commissioned by WHO, found that vaccine supply might be insufficient through the medium term, with a constrained supply potentially during the first 4-6 years following expected first introductions in 2023.
It is difficult to predict when the supply constraints might ease as several factors influence the situation. These include how quickly production of the recommended RTS,S/AS01 vaccine can increase and whether and when a second malaria vaccine might become available for use.
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.
In parallel, until vaccine supply is sufficient to meet the need, a fair and equitable mechanism is needed to guide, in full transparency, how supply is prioritised, based on best available evidence, shared values and appropriate input by key parties.
The WHO says in-country vaccine deployment should respect sovereign decision-making and align with the High Burden to High Impact (HBHI) approach to sub-national tailoring of malaria interventions.
The intended audience of the Framework are policy makers in malaria-endemic countries, the manufacturer(s), Gavi, the Vaccine Alliance and other funding, implementing and technical partners.
The WHO recommends that the RTS,S/AS01 malaria vaccine is provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden. Countries may consider providing the vaccine seasonally, with a 5-dose strategy in areas with highly seasonal malaria or areas with perennial malaria transmission with seasonal peaks.
Affected countries
Most of the affected countries are currently eligible to receive support from Gavi to facilitate vaccine introductions, including the new malaria vaccine.
Malaria Vaccine Implementation Programme countries Ghana, Kenya and Malawi will receive doses to continue vaccinations in pilot areas.
Uganda is among new countries where introductory allocations were made. Other countries in this category are Benin, Burkina Faso, Burundi, Cameroon, Democratic Republic of the Congo, Liberia, Niger, and Sierra Leone.
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 prioritises those doses to areas of highest need, where the risk of malaria illness and death among children are highest.
According to current WHO guidance, moderate to high malaria transmission settings are defined as those with an annual incidence greater than around 250 cases per 1000 population or a prevalence of P. falciparum infection in children aged 2-10 years of approximately 10% or more.
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According to a new WHO births estimate for 2023 by need in sub-Saharan African countries with moderate to high malaria transmission, Uganda has an annual target population of 1.6 million eligible people for the vaccine Nigeria has the highest estimated need population of 7.2 million, followed by the DR Congo 3.6, and Mozambique 1 million. Countries with the least estimated need for the vaccine are Equatorial Guinea 25,000, Ethiopia 26,000, Gabon 58,000 and Mauritania 73,000.
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.
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.
"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."
