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Geneva, Switzerland · 2 October 2023 — The World Health Organization has recommended the R21/Matrix-M malaria vaccine for the prevention of malaria in children, marking only the second malaria vaccine to receive WHO endorsement. The recommendation, issued on 2 October 2023, follows advice from the WHO Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Group (MPAG), and was endorsed by WHO Director-General Dr Tedros Adhanom Ghebreyesus following their biannual meeting held 25–29 September.
The addition of R21 to the WHO-recommended vaccine arsenal is expected to resolve the most pressing constraint in global malaria vaccination: supply. Demand for the first WHO-recommended malaria vaccine, RTS,S/AS01, has far exceeded available supply since its recommendation in 2021. The R21 vaccine, developed by the University of Oxford's Jenner Institute and manufactured by the Serum Institute of India, is projected to become available to countries by mid-2024.
A Second Tool for a Persistent Killer
Malaria remains one of the deadliest infectious diseases for children in the African Region, where nearly half a million children die from the disease each year. The parasite Plasmodium falciparum — the deadliest malaria species and the most prevalent on the African continent — is the target of both R21 and RTS,S.
The two vaccines have not been tested in a head-to-head trial. WHO notes there is no evidence to date showing one vaccine performs better than the other. The choice of product should be based on programmatic characteristics, vaccine supply, and affordability.
"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."
Evidence Behind the Recommendation
The WHO recommendation was informed by evidence from an ongoing R21 vaccine clinical trial programme and supporting studies. Key findings included:
| Feature | R21/Matrix-M | RTS,S/AS01 |
|---|---|---|
| Seasonal efficacy (3-dose) | 75% | Similar when given seasonally |
| Age-based efficacy (3-dose) | 66% | Demonstrated in pilot programme |
| Cost per dose | US$ 2–4 | Higher |
| WHO recommendation | October 2023 | October 2021 |
| Prequalification status | In progress | Prequalified |
Mathematical modelling estimates indicate the public health impact of R21 is expected to be high across a wide range of malaria transmission settings, including low transmission areas. At a price of US$ 2–4 per dose, the cost-effectiveness is comparable with other recommended malaria interventions and childhood vaccines.
From Pilot to Scale
The WHO recommendation builds on the foundation laid by the Malaria Vaccine Implementation Programme (MVIP), through which nearly 2 million children in Ghana, Kenya, and Malawi have received the RTS,S vaccine since 2019. The pilot programme demonstrated substantial impact in reducing severe malaria illness, hospitalisations, and child deaths, and provided critical evidence on feasibility and safety in real-world settings.
Dr Matshidiso Moeti, WHO Regional Director for Africa, underscored the significance for the continent:
"This second vaccine holds real potential to close the huge demand-and-supply gap. Delivered to scale and rolled out widely, the two vaccines can help bolster malaria prevention and control efforts and save hundreds of thousands of young lives in Africa from this deadly disease."
Next Steps and Global Rollout
At least 28 countries in Africa plan to introduce a WHO-recommended malaria vaccine as part of their national immunisation programmes. Gavi, the Vaccine Alliance, has approved technical and financial support for rollout in 18 countries. The RTS,S vaccine was scheduled for rollout in some African countries in early 2024, with R21 expected to follow by mid-2024.
The next formal step for R21 is completion of WHO prequalification, which would enable international procurement by UNICEF, Gavi, and other partners for broader rollout. Prequalification was subsequently achieved in December 2023.
The Broader Immunisation Landscape
The SAGE meeting also reviewed progress against the Immunization Agenda 2030 (IA2030) targets. Progress was found to be stalled for six of seven impact goals due to the COVID-19 pandemic's disruption of routine immunisation. While recovery is underway, it remains uneven — particularly slow in low-income countries and fragile settings. Low coverage of measles-containing vaccines has increased the risk of large, disruptive outbreaks.
A shared action agenda for 2023–2024 was developed with six trajectories: catch-up and strengthening of immunisation programmes, equity promotion, regaining control of measles, investment advocacy, accelerating introduction of WHO-recommended vaccines, and advancing adolescent vaccination.
Sources
- World Health Organization, "WHO recommends R21/Matrix-M vaccine for malaria prevention in updated advice on immunization," 2 October 2023.
- University of Oxford, "Oxford R21/Matrix-M malaria vaccine receives WHO recommendation for use," 2 October 2023.
- World Health Organization, "WHO prequalifies a second malaria vaccine," 21 December 2023.
- WHO Malaria Vaccine Implementation Programme.
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