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First-ever malaria vaccines

What it is

RTS,S and R21/Matrix-M are the first vaccines developed to prevent malaria, and the first vaccines against a human parasitic disease to be recommended for widespread use. Both vaccines target Plasmodium falciparum, the parasite responsible for most malaria cases and deaths in Africa, helping the immune system prevent the parasite from infecting the liver.

Why it matters

Malaria remains a major public health threat in sub-Saharan Africa, particularly for young children. In 2024, 282 million people fell ill with malaria and 610,000 died, with 95% of deaths occurring in the WHO African Region.[1] RTS,S and R21/Matrix-M vaccines could prevent millions of illnesses and save thousands of children every year.

©Global Health EDCTP3.

The story

EDCTP played a pivotal role in the development of the first malaria vaccines, RTS,S and R21/Matrix-M, by funding clinical research and supporting the capacity, infrastructure and networks that made these breakthroughs possible.

RTS,S/AS01, developed by GSK and the PATH Malaria Vaccine Initiative, was tested in a landmark Phase III trial across eleven research centres in seven African countries, one of the largest malaria vaccine trials ever conducted. Published in 2011, the results showed that RTS,S reduced clinical malaria episodes by around one-third in young children.[2] EDCTP contributed to this milestone by strengthening clinical trial capacity at research institutions in Mozambique, Tanzania, Kenya and other trial countries, through its Networks of Excellence for Clinical Trials, fellowships and infrastructure investments.[3]

Following a four-year pilot programme that vaccinated more than two million children in Ghana, Kenya and Malawi and cut all-cause child mortality by 13%, the World Health Organization (WHO) recommended RTS,S for widespread use among children in malaria-endemic parts of sub-Saharan Africa in October 2021.[4] EDCTP2 supported this pilot phase directly, funding case-control studies in the three countries to gather further evidence on the vaccine’s safety and its effect on severe malaria.[5]

A second vaccine, R21/Matrix-M, was developed by the University of Oxford’s Jenner Institute together with the Serum Institute of India, using an adjuvant developed by Novavax. EDCTP2 funded the Multi-Stage Malaria Vaccine Consortium investing €15.6 million in grant funding (2018-2025) to support clinical trials of promising vaccine candidates.[6] The EDCTP2-funded Phase Ib/IIb trial of R21/Matrix-M in Burkina Faso reported 77% efficacy in children aged five to seventeen months, exceeding WHO’s target of 75% for a first-generation malaria vaccine.[7] Building on these and subsequent Phase III results, WHO recommended R21/Matrix-M for widespread use in October 2023.[8] EDCTP had funded the vaccine’s development for more than ten years, alongside Wellcome, the European Investment Bank and other funders.[9]

Both vaccines are safe and effective, and used along with other malaria control strategies, they are expected to significantly reduce malaria mortality and morbidity, especially among young children. Since the pilot began in Ghana, Kenya and Malawi in 2019, uptake has accelerated rapidly: 21 additional countries introduced routine malaria vaccination in 2024 and 2025 alone, bringing the total to 24 African countries by November 2025, with more expected to follow. More than 40 million doses have been delivered so far, and Gavi aims to help countries protect a further 50 million children between 2026 and 2030.[10]

Global Health EDCTP3 continues to support malaria vaccine research to boost vaccine effectiveness[11] and optimise vaccine deployment and use.[12]

Affordable access

RTS,S/AS01 is currently supplied by GSK, with production gradually being transferred to Bharat Biotech to expand manufacturing capacity and vaccine availability. GSK committed to pricing the vaccine at no more than the cost of manufacturing plus a maximum 5% financial return, resulting in a ceiling price of €9.30 per dose for the 2023-2025 period.[13] From 2026 onwards, increased production capacity and manufacturing efficiencies are expected to enable further price reductions, with Bharat Biotech and GSK committing to reduce the price to below US$5 per dose by 2028.[14]

In November 2025, Gavi and UNICEF agreed a new price for R21/Matrix-M of US$2.99 per dose, down from US$3.90, a reduction financed through the International Finance Facility for Immunisation and projected to save up to US$90 million, equivalent to more than 30 million additional doses. The lower price is expected to take effect toward the end of 2026 or in early 2027.[10]

 

Sources:

[1] World malaria report 2025 | WHO

[2] The RTS,S Clinical Trials Partnership. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med. 2011 Nov 17;365(20):1863-1875. doi: 10.1056/NEJMoa1102287.

[3] RTS,S/AS01 malaria vaccine: EDCTP contributions and next steps | EDCTP

[4] Shipment of newest malaria vaccine, R21, to Central African Republic marks latest milestone for child survival | WHO

[5] New horizons for malaria vaccines | EDCTP

[6] Driven to end malaria: how the EDCTP Association turns innovation into impact | EDCTP 

[7] EDCTP-funded trial of R21/Matrix-M malaria vaccine shows efficacy of 77% | EDCTP

[8] WHO recommends R21/Matrix-M vaccine for malaria prevention in updated advice on immunization | WHO

[9] WHO recommends R21/Matrix-M malaria vaccine | EDCTP

[10] Gavi and UNICEF announce equitable pricing deal for malaria vaccine to protect 7 million more children by end of decade | Gavi

[11] PfVIMT project | Global Health EDCTP3 

[12] IMVACS project | Global Health EDCTP3 & MVC-2G project | Global Heath EDCTP3 

[13] Responsible Business Report 2025 | GSK

[14] Malaria vaccines: Questions and Answers on Supply, Price, and Market Shaping | UNICEF Supply Division