A second vaccine to fight malaria was recommended by the World Health Organization (WHO), paving the way for a significant expansion in the global supply of malaria vaccines and increasing the diverse range of tools available to fight malaria.
The R21/Matrix-M vaccine was developed by the Jenner Institute at the University of Oxford to protect children living in malaria-endemic areas from the most common and deadly form of malaria, Plasmodium falciparum.
The latest results from the ongoing Phase 3 trials found three doses of the vaccine reduced symptomatic malaria cases by 75% over 12 months in areas affected by seasonal malaria, where most cases occur during the rainy season.
Vaccine efficacy was also demonstrated when delivered based on age in areas with low to moderate malaria transmission, however further studies will be required to establish the vaccine’s efficacy in regions with high levels of malaria transmission year-round.
The announcement is a significant step in the fight against malaria, which is facing challenges in a number of ways including the issues around climate and health, as well as a $3.8bn funding gap globally, each year.
The RBM Partnership however warns that single interventions are not silver bullets designed to solve all the challenges of malaria. A higher impact will be achieved when combined with other highly cost-effective malaria control tools, to help us get closer to the 2030 goals.
Dr Michael Charles, CEO of the RBM Partnership said, “The R21 vaccine is an important addition to our malaria toolbox – with estimates suggesting it will help save tens of thousands more lives each year – but there is no silver bullet to end malaria.
“Countries face different challenges and will need to determine how R21 and RTS,S (the world’s first vaccine) can complement their existing malaria control strategies. This new vaccine will be highly effective to fight malaria, but must be used in tandem with other tools such as insecticide-treated nets, indoor residual spraying and preventive medicines to have the greatest impact.
“While this announcement is a step in the right direction, there are also still major hurdles to overcome. In the face of significant funding shortfalls and the growing threats of insecticide and drug resistance, and climate change further investment must be urgently mobilized to scale-up, manufacture and roll-out malaria vaccines to ensure they are readily accessible to countries that decide to use them.”
The recommendation was announced today at a WHO media briefing. “As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria. Now we have two,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.“
Demand for the RTS,S vaccine far exceeds supply, so this second vaccine is a vital additional tool to protect more children faster, and to bring us closer to our vision of a malaria-free future.”
R21 is the second malaria vaccine to be recommended by WHO, following RTS,S in 2021. Earlier this year, Gavi, UNICEF and WHO came together to allocate the available supply of 18 million doses of the first vaccine to areas with the greatest need across 12 African countries over 2023-2026.
However, demand for the vaccine is estimated to exceed 80 to 100 million doses per year.
As part of a package of prioritized malaria control interventions, R21 will be scaled up alongside the existing vaccine to increase global supply, reduce average costs and enter other countries, reaching more children living at risk.
WHO recommends the vaccine is used to prevent malaria in children up to five years old living in areas where malaria is a public health risk, particularly in areas with moderate to high transmission.
The recommendation follows an extensive efficacy and safety review by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) and Malaria Policy Advisory Group (MPAG) Working Group.
The manufacturer, the Serum Institute of India, can now pursue WHO prequalification status to assure the quality of the vaccines it produces and enable global procurement agencies including Gavi and UNICEF to procure the vaccine at scale.
GAVI, the Vaccine Alliance also welcomes today’s announcement and emphasizes the key role it could play as the malaria community aims to advance its goals towards 2030.
“The joint SAGE-MPAG recommendation to WHO of the R21/Matrix-M vaccine represents another major step towards our goal of creating a malaria-free life for every child,” said David Marlow, CEO, Gavi.
“This vaccine, along with the existing RTS,S/AS01e vaccine, will be an effective complement to existing malaria interventions. Once it receives WHO prequalification, it will play a key role in meeting the high demand we are seeing in endemic countries.”
The Global Fund has long supported the RBM Partnership and the fight to end malaria, alongside HIV and TB. It raises and invests more than US$4 billion a year to fight the deadliest infectious diseases, including malaria.
“Malaria has shown that we must stay ahead of it to eliminate it,” said Peter Sands, Executive Director of the Global Fund.
“Multiple crises, including climate change, are fueling the spread of malaria and keeping us off the trajectory required to end this disease by 2030. To get back on track, innovation is crucial.
“We welcome the R21 vaccine along with the other recent innovations. When deployed together with other highly cost-effective malaria prevention tools such as mosquito nets and seasonal malaria chemoprevention, this new vaccine can help reduce malaria cases and deaths.”
Significant progress has been made to develop other potential vaccines, including an initiative from the kENUP Foundation and BioNTech aiming to develop the first mRNA-based prophylactic malaria vaccine, candidates targeting other stages in the parasite’s lifecycle, as well as several efforts to develop monoclonal antibodies.
The RBM Partnership urges donor and malaria-endemic countries to continue to accelerate the development of improved tools and next-generation technologies to stay ahead of the rapidly evolving mosquito and malaria parasite.
The RBM Partnership to End Malaria is the largest global platform for coordinated action against malaria. Originally established as Roll Back Malaria (RBM) Partnership in 1998, it mobilizes for action and resources and forges consensus among partners.
The Partnership comprises more than 500 partners, including malaria-endemic countries, their bilateral and multilateral development partners, the private sector, nongovernmental and community-based organizations, foundations, and research and academic institutions.