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 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.
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 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."
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"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."
