Malaria Vaccines 2023

Authored by
Last reviewed
June 1, 2023
Content Overview
Malaria is a vaccine preventable disease with approved vaccines available internationally, but not in the U.S. as of June 2023.

Malaria Vaccines June 2023

According to the U.S. Centers for Disease Control and Prevention (CDC), Malaria is a vaccine-preventable mosquito-borne disease caused by a parasite. The malaria vaccines RTS,S, and R21 have been approved for use in Africa and are reported to be effective at preventing disease. On October 6, 2021, the World Health Organization (WHO) recommended the Mosquirix™ (RTS,S) malaria vaccine and the R21/Matrix-M™ vaccine was approved in Nigeria and Ghana in 2023. The WHO Guidelines for malaria consolidate the Organization's most up-to-date recommendations. In addition, on World Malaria Day 2023, the WHO called for increased implementation of new and existing interventions to save lives from malaria.

As of June 2023, the U.S. Food and Drug Administration (FDA) and the WHO had not approved a malaria vaccine. However, the FDA approved Artesunate to treat severe malaria in adult and pediatric patients in May 2020.

Malaria Vaccines Approved 2023

Mosquirix RTS,S/AS01 (RTS,S) Malaria Vaccine - GSK's Mosquirix RTS, S/AS01 is a recombinant vaccine of the P. falciparum circumsporozoite protein from the pre-erythrocytic stage.

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

According to Coherent Market Insights, the malaria vaccine market segment was valued at $41 million in 2022 and is expected to realize an annual growth rate of about 29% thru 2030.

Malaria Vaccine Candidates 2023

RH5.1/AS01 Malaria Vaccine - RH5.1/AS01 is a novel recombinant malaria antigen developed at the University of Oxford.

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 volunteers in the U.S. with no history of malaria.

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

Maryland-based 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 challenge clinical trials.

Ocean Biomedical has been awarded a new patent for a third parasite target called PfCDPK-5 that can potentially be used to prevent the parasite at multiple stages in the malaria cycle. The latest patent is for the discovery that demonstrates the role of antibodies to PfCDPK-5 in preventing merozoites from escaping infected red blood cells and thus attenuates parasite multiplication in the bloodstream. In addition, recent studies in Nature identified PfGARP as a target of human antibodies which kill up to 100% of parasites in vitro.

Malaria Monoclonal Antibody 2023

Artesunate for Injection™ is indicated for infants, children, adults, and pregnant women with severe malaria or those unable to tolerate oral antimalarials. Available in vials of 110mg, Artesunate for Injection is dosed at 2.4 mg/kg given intravenously at 0, 12, and 24 hours, then daily for up to seven days. If after 24 hours of Artesunate, the percent parasitemia is ≤ 1% and the patient can tolerate oral medications, the patient can be switched to an antimalarial regimen.

The Lancet Infectious Diseases published results from an NIAID phase 1 study on January 25, 2023, that found the antimalarial monoclonal antibody CIS43LS conferred high protection against parasitemia at doses of 20 mg/kg or 40 mg/kg administered intravenously followed by controlled human malaria infection, providing evidence that this approach might be helpful to prevent malaria across several clinical use cases. The NEJM published an Original Article on October 31, 2022: Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali. CONCLUSIONS - CIS43LS was protected against P. falciparum infection in a phase 2 clinical trial over a 6-month malaria season without evident safety concerns. And in a related Editorial by Umberto D'Alessandro, M.D., Ph.D., currently, available interventions for malaria control are unlikely to achieve the vision of a malaria-free world.On October 18, 2022, the peer-review journal Cell published results from a phase 1 clinical trial that concluded: L9LS, a potent and safe antimalarial monoclonal antibody, demonstrated 88% protective efficacy against infection in a phase 1 trial in healthy adults. And the NEJM published on August 4, 2022, an ORIGINAL ARTICLE: Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria. 

Malaria Medications 2023

Novartis and Medicines for Malaria Venture announced on November 23, 2022, their decision to move to Phase 3 study for a novel ganaplacide/lumefantrine-SDF combination in adults and children with malaria. Ganaplacide is a novel agent with a new mechanism of action combined with a new formulation of lumefantrine optimized for once-daily dosing. Pyramax® (pyronaridine-artesunate) was included in the WHO's list of pre-qualified medicines in 2012 and the WHO's Essential Medicines Lists for adults and children in 2017. Pyramax subsequently underwent a positive review by the WHO's Advisory Committee on the Safety of Medicinal Products in 2019, including interim data from the CANTAM study. Insight Partners published the latest research report on the Malaria Treatment global market is estimated to grow with a CAGR of 4.9% from 2022 to 2028.

Malaria and Dengue Testing

An expert panel in India pointed out that Malaria tests need to be carried out alongside dengue. Malaria tests look for parasites in the blood, and the Dengue profile is a lab test panel used to diagnose dengue fever.

Malaria Netting

On March 14, 2023, the WHO recommended a new class of long-lasting insecticidal nets (LLINs), combining mixtures of insecticides with different modes of action. The Lancet published results from a study in January 223 that found chlorfenapyr-pyrethroid LLINs provided greater protection from malaria than pyrethroid-only LLINs in an area with pyrethroid-resistant mosquitoes. Pyriproxyfen-pyrethroid LLINs conferred protection similar to pyrethroid-only LLINs. A study published by BMJ Global Health Journal suggests that LLINs reduced the incidence in the first year. However, of the 88 malaria-endemic countries that provided data for 2010–2020, 78 have detected resistance to at least one insecticide class reported to the WHO in December 2022.

Malaria Outbreaks

Updated malaria outbreak news is posted at

Malaria Vaccine News 2023

April 25, 2023 - The WHO urges increased implementation of recommended tools to combat malaria.

April 21, 2023 - VOA Africa reported about ten other African countries' regulatory authorities are reviewing data assessing malaria vaccines.

April 13, 2023 - The Republic of Ghana's FDA approved the R21/Matrix-M malaria vaccine. Serum Institute of India Pvt Ltd has provided vaccines, sponsored Phase III licensure clinical trials, and established manufacturing capacities of more than 200 million doses annually.

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

December 23, 2022 - "The trial initiation is an important milestone in our efforts to help address diseases with high unmet medical need. Our objective is to develop a vaccine that can help to prevent Malaria and reduce mortality. Over the next months, we aim to evaluate different antigens with scientific rigor to identify the optimal candidate," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech, in a press release.

December 22, 2022 - "Our study shows that the (PfSPZ) vaccine can be given to malaria-experienced adults in a highly endemic area and still provide protection, which is difficult and complicated as these individuals already have significant immune responses to malaria parasites that a vaccine must overcome for it to be successful," said corresponding study author Matthew B. Laurens, MD, MPH, Professor of Pediatrics at UMSOM and Director, International Clinical Trials Unit in the Malaria Research Group at CVD.

December 15, 2022 - Medicines for Malaria Venture and the Africa CDC signed a Memorandum of Understanding to strengthen African manufacturing of malaria medicines.

December 1, 2022 - The Lancet Infectious Disease published an early release analysis that concluded - A booster dose of R21/Matrix-t one year following the primary three-dose regimen maintained high efficacy against first and multiple episodes of clinical malaria. Furthermore, the booster vaccine-induced antibody concentrations correlated with vaccine efficacy. 

December 1, 2022 - A news study - mRNA-LNP expressing PfCSP and Pfs25 vaccine candidates targeting infection and transmission of Plasmodium falciparum - A combination of vaccines targeting both the infective stage and sexual/midgut stages is expected to interrupt malaria transmission.

October 31, 2022 - The Lancet published: Usefulness of seasonal malaria chemoprevention in the Sahel.

October 4, 2022 - NPJ Vaccines published: Needle-free, spirulina-produced Plasmodium falciparum circumsporozoite vaccination provides sterile protection against pre-erythrocytic malaria in mice.

September 29, 2022 - India's drug regulator DCGI granted permission to export the R21/Matrix-M™ malaria vaccine manufactured by the Serum Institute of India to the U.K. 

September 15, 2022 - GAVI reported: Malaria vaccine: the road has been long and tortuous, but we're getting there.

September 6, 2022 - GSK plc announced the WHO had awarded Prequalification status to the Mosquirix vaccine.

August 4, 2022 -  According to a National Institutes of Health phase 1 clinical study results, one injection of a candidate monoclonal antibody known as L9LS was safe and highly protective in adults exposed to malaria parasites.

July 21, 2022 - The WHO welcomed the launch by Gavi of the opportunity for countries to apply for funding to introduce or fourth roll-output of the RTS,S/AS01 (RTS,S) malaria vaccine. This international support of nearly US$ 160 million from 2022-2025 will facilitate increased malaria vaccine access.

June 13, 2022 - The journal Nature published: Plasmodium falciparum 7G8 challenge provides a conservative prediction of efficacy of PfNF54-based PfSPZ Vaccine in Africa. 'We propose VE against Pf7G8 CHMI for providing pivotal data for malaria vaccine licensure for travelers to Africa, and potentially for the endemic population because the genetic distance of Pf7G8 from the Pf vaccine strain makes it a stringent surrogate for Pf parasites in Africa.'

June 10, 2022 - The journal Science Immunology published: Clonal evolution and TCR specificity of the human TFH cell response to Plasmodium falciparum CSP. Findings: These data suggest that the high parasite diversity in endemic areas will limit boosting of the vaccine-induced TFH cell response by natural infections. Our results may guide the further design of PfCSP-based malaria vaccines able to induce potent T helper cell responses for broad, long-lasting antibody responses.

March 14, 2022 - Medicines for Malaria Venture announced that the Australian Therapeutic Goods Administration approved the use of single-dose Kozenis (tafenoquine) in children aged two years and above in combination with chloroquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria. The approval includes a novel, 50 mg dispersible tablet that can be dispersed in water.

March 4, 2022 - The WHO published an updated position paper on the RTS,S/AS01 (RTS,S) malaria vaccine that includes the October 2021 recommendation calling for the broader use of the vaccine among children living in areas of moderate-to-high P. falciparum malaria transmission. The paper complements the recent addition of the recommendation to the WHO GuidelinesMalarialaria.

February 24, 2022 - The Lancet published a Commentary: COVID-19 vaccine results might inform malaria vaccine strategies.

February 3, 2022 - The NEJM published an Original Article: Mosquito Net Use in Early Childhood and Survival to Adulthood in Tanzania. And a related Editorial offered further insights.

January 17, 2022 - The Lancet published a review statiIndividualizedlized conservative fluid management is recommended in patients with severe malaria.' This study focused on fluid therapy as an essential support for patients with severe malaria. Patients with severe malaria usually have an average cardiac index, vascular resistance, blood pressure, and a small degree of hypovolaemia due to dehydration. Cell hypoxia, reduced kidney function, and acidosis result from microcirculatory compromise and malarial anemia, which minimize tissue oxygenation, not hypovolaemia. Hence, aggressive fluid loading does not correct acid-base status, enhance kidney function, or improve patient outcomes, and it risks complications such as pulmonary edema.

October 29, 2021 - The World Health Organization endorsed the first-ever vaccine against malaria. This achievement is the product of 30 years of research and development.