Malaria Vaccines

Malaria Vaccines 2025

As of January 11, 2025, the World Health Organization (WHO) recommends the programmatic use of malaria vaccines to prevent P. falciparum malaria in children living in malaria-endemic areas. In November 2024, the WHO published a revised version of the consolidated Guidelines for malaria with an updated vaccine recommendation. The WHO and the European Medicines Agency (EMA) recommend Mosquirix™ (RTS,S/AS01) and R21 / Matrix-M™ vaccines for travelers visiting malaria-endemic countries. These malaria vaccines were added to the WHO list of prequalified vaccines in 2024. As of 2025, 17 countries have introduced malaria vaccines through routine immunization. 

The WHO's World Malaria Report 2024 says the availability of two malaria vaccines is expected to increase supply and make broad-scale deployment across Africa possible. The WHO estimates the annual global demand for malaria vaccines at 40–60 million doses by 2026 and 80–100 million doses annually by 2030.

Malaria Vaccines Approved

Mosquirix™ RTS, S/AS01 (RTS,S) Malaria Vaccine - GSK's Mosquirix is a recombinant vaccine of the P. falciparum circumsporozoite protein from the pre-erythrocytic stage. During the introduction of the RTS,S/AS01 malaria vaccine under the Malaria Vaccine Implementation Programme, more than two-thirds of children who reportedly did not sleep under an insecticide-treated net received at least one dose of RTS,S/AS01. 

R21/Matrix-M™ Serum Institute of India's malaria vaccine was designed in 2011 and co-produced by scientists at the University of Oxford, Novavax AB, and Novavax Inc. 

As of January 2025, the U.S. Food and Drug Administration had not approved a malaria vaccine.

Malaria Vaccine Candidates 2025

RH5.1/Matrix-M malaria vaccine developed at the University of Oxford targets blood-stage malaria, unlike previously approved malaria vaccines that target the pre-erythrocyte stage. The results of the phase 2b trial by Natama and colleagues indicated that RH5.1/Matrix-M had a vaccine efficacy of 55% (95% CI 20 to 75; p=0·0071) when administered at 0, 1, and 5-month intervals. On December 10, 2024, the researcher wrote, 'RH5.1/Matrix-M appears safe and highly immunogenic in African children and shows promising efficacy against clinical malaria when given in a delayed third-dose regimen.'

Sanaria Inc.'s non-replicating whole parasite PfSPZ vaccine candidate is made with a live-attenuated form of the malaria parasite Plasmodium falciparum sporozoite. Clinical studies have been shown to provide about 90% protection in a challenging clinical trial. On August 14, 2024, The Lancet published results from clinical trials that showed PfSPZ vaccination without presumptive antimalarial treatment before the first vaccine dose did not show efficacy. In the preconception trial, a related editorial, researchers speculated that the PfSPZ vaccination might avert malaria-related early pregnancy losses since parasitemia risk during the periconception period was reduced by 65 to 86%.

The Lancet Infectious Disease published in July 2023 results from a phase 1 study evaluating the effectiveness of the Gamete vaccine Pfs230D1-EPA/Alhydrogel to zygote vaccine Pfs25-EPA/Alhydrogel. Pfs230D1, but not the Pfs25 vaccine, induces durable serum functional activity in Malian adults.

Versatope Therapeutics Inc. is developing a bi-specific malaria vaccine using a target that blocks the initial malaria infection and transmission.

In a phase 1 study, the ProC6C-AlOH/Matrix-M vaccine candidate elicited the highest levels of functional antibodies, meriting further investigation.

BNT165 mRNA Malaria Vaccine - BioNTech is building the first vaccine for malaria based on mRNA technology to eradicate mosquito-borne illness. The phase 1 clinical trial evaluates the safety, tolerability, and exploratory immunogenicity of the 3-dose vaccine candidate BNT165b1 and is expected to enroll 60 U.S. volunteers with no malaria history.

BioNTech's Malaria project was first announced in July 2021.

Ocean Biomedical has been awarded a new patent for a parasite target called PfCDPK-5. This target could potentially prevent the parasite at multiple stages in the malaria cycle in a multivalent mRNA-based malaria vaccine. In addition, recent studies in Nature identified PfGARP as a target of human antibodies that kill up to 100% of parasites in vitro. 

AgTRIO mRNA-lipid nanoparticle was assessed for its potential usefulness as a vaccine against malaria.

Malaria Monoclonal Antibody Passive Immunization 

The New England Journal of Medicine published results from a phase 2 study on April 26, 2024. The study demonstrated that a single subcutaneous injection of the NIAID's experimental L9LS (VRC-MALMAB0114-00-AB) malaria monoclonal antibody offered up to 77% protection against P. falciparum infection and clinical malaria over a six-month period. According to the study authors, "the data from our trial support the administration of a single dose of L9LS to school-aged children before the malaria season."

The Phase 2 NIAID-USTTB evaluated the safety and efficacy of a one-time, intravenous infusion of a monoclonal antibody called VRC-MALMAB0100-00-AB (CIS43LS). The antibody was found to be up to 88.2% effective at preventing infection over 24 weeks, demonstrating for the first time that a monoclonal antibody can prevent malaria infection in an endemic region. This antibody was previously shown to neutralize the sporozoites of P. falciparum in the skin and blood before they could infect liver cells.

Malaria Treatments

Various antimalarial treatments are approved by the U.S. CDC in 2024.

Malaria Vaccine News

October 17, 2024 - Nigeria launched a malaria vaccination program.

April 25, 2024 - Benin, Liberia, and Sierra Leone launched malaria vaccinations targeting millions of children.

January 8, 2024 - Cameroon's Minister of Public Health confirmed the African country will introduce a malaria vaccine in January 2024.

October 12, 2023 - UNICEF, the world's largest single vaccine buyer, announced an agreement to secure a supply of the world's second malaria vaccine, R21/Matrix-M.

October 2, 2023 - The World Health Organization (WHO) has recommended a new vaccine, R21/Matrix-M, to prevent malaria in children.

August 22, 2023 - An editorial published in The Lancet says the WHO recommends that seasonal malaria vaccination with recombinant circumsporozoite protein-based RTS, S/AS01E, and chemoprevention, with sulfadoxine, pyrimethamine, and amodiaquine be administered monthly during the rainy season when malaria transmission peaks.

August 18, 2023 - GAVI reported that, as of mid-2023, 96.5% of eligible children in Vihiga, Kenya, have received at least one of four doses of the RTS,S vaccine.

July 11, 2023 - Based on discoveries by Scientific Co-founder Jonathan Kurtis, MD, Ph.D., Ocean Biomedical is working on a multivalent mRNA-based malaria vaccine with the potential to target several stages in the malaria cycle.

June 8, 2023 - Ocean Biomedical, Inc. announced a new patent for his malaria vaccine discoveries that may be used to prevent the parasite at multiple stages in the malaria cycle.

June 7, 2023 - The journal Vaccines published a new study: A mosquito AgTRIO mRNA vaccine contributes to immunity against malaria.

April 13, 2023 - The Republic of Ghana's FDA approved the R21/Matrix-M malaria vaccine.

January 25, 2023 - The Lancet published - Monoclonals against malaria: the promise of passive protection.