R21/Matrix-M™ Malaria Vaccine May 2023

The R21/Matrix-M™ vaccine includes Novavax AB proprietary saponin-based Matrix-M adjuvant and is licensed to and manufactured by the Serum Institute of India Private Ltd (SII). The R21 was created by the University of Oxford Jenner Institute, located in England. In 2017, Oxford published an abstract: High-level efficacy in humans of a next-generation plasmodium falciparum anti-sporozoite vaccine: R21 in Matrix-M adjuvant. Under Novavax's agreement with Serum Institute (SII), it has the commercial rights to use Matrix-M in the vaccine in regions where the disease is endemic and pay Novavax royalties. Additionally, Novavax has the commercial rights to sell and distribute the SII-manufactured vaccine in certain countries, primarily in the travelers' and military vaccine markets. R21/Matrix-M is produced by expressing recombinant HBsAg virus-like particles in Hansenula polymorpha, comprising the central repeat and the C-terminus of the circumsporozoite protein (CSP) fused to the N-terminal end of HBsAg10. 

On April 20, 2021, a non-peer-reviewed paper said in a press release these new results support our high expectations for the potential of this vaccine, which we believe is the first to reach the WHO's goal of a vaccine for malaria with at least 75% efficacy. On September 7, 2022, The Lancet Infectious Diseases published: Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after two years follow-up in children in Burkina Faso: a phase 1/2b randomized controlled trial, that concluded - A booster dose of R21/Matrix-M at 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. On December 19, 2022, the journal Nature published an article: After 30 years of development, there is finally a vaccine for malaria. But it might take years for the children who need it.

Oxford University's Jenner Institute is within the Nuffield Department of Medicine, located at the Old Road Campus Research Building in Headington, Oxford. Serum Institute of India Pvt. Ltd. is a significant vaccine manufacturer by the number of doses produced and sold globally (more than 1.5 billion doses), which includes Polio vaccine, Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps, Rubella as well as Pneumococcal and Covid-19 vaccines. The Poonawalla Bio-Tech Park at Manjari in Pune, India, is over 42 acres.

R21/Matrix-M Availability 2023

The Food and Drugs Authority of the Republic of Ghana licensed the R21/Matrix-MTM malaria vaccine on April 13, 2023. Nigeria issued its authorization on April 17, 2023. Previously, the Drugs Controller General of India granted permission on September 29, 2022, to send two lakh doses of the R21/Matrix-M vaccine manufactured by Serum Institute to the UK. SII Chief Executive Adar Poonawalla told Reuters on April 21, 2023, he is producing 20 million doses "at-risk" in the next two months.

R21/Matrix-M Indication

The R21/Matrix-M Malaria Vaccine is indicated to prevent Plasmodium falciparum malaria, a mosquito-borne disease. The vaccine has been approved for use in certain countries in children aged 5 to 36 months. There were 229 million malaria cases worldwide in 2019, with an estimated 409,000 deaths. According to the World Health Organization (WHO), children under five are the most vulnerable, accounting for 67% of malaria-related fatalities worldwide in 2019. On December 8, 2022, the WHO published the World Malaria Report 2022, which offers in-depth information on the latest malaria control and elimination trends at global, regional, and country levels.

R21/Matrix-M Dosage

R21/Matrix-M Malaria low dose vaccine three-dose primary regime dosage was tested in the Phase 2b clinical trial. 

R21/Matrix-M Booster Dose

This phase 1/2b randomized controlled clinical trial reports the safety, immunogenicity, and efficacy of the R21/Matrix-M malaria vaccine. The administration of a booster dose 12 months following the 3-dose primary series of R21/Matrix-M vaccinations shows the added benefit of a fourth dose when administered before the malaria season. Vaccine efficacy was maintained in the high-dose adjuvant group, at 80% following the booster vaccine over 12 months and 75% over 24 months after the prior three-dose regimen. Furthermore, vaccine efficacy against multiple episodes of clinical malaria was similar (78%) over two years of follow-up. R21/Matrix-M has a favorable safety profile and induces high levels of malaria-specific anti-NANP antibodies that correlate with the observed protection against clinical malaria.

R21/Matrix-M Vaccine Manufacturing

The University of Oxford has partnered with Serum Institute of India Pvt Ltd. (SIIPL) to manufacture R21/Matrix-M to ensure the provision of low high volumes of low-cost vaccines and access in countries where it is required the most. SIIPL has confirmed its commitment to providing about 200 million doses annually.

R21/Matrix-M Vaccine News 2023

May 10, 2023 - Vakzine Projekt Management GmbH (VPM), a German consultancy and service provider, announced, "This partnership is proof of our ambition towards supporting the development of safe and effective vaccines to ensure healthy living for all,” stated Dr. Leander Grode, Managing Director of VPM.

April 13, 2023 - GAVI reported: Five things you need to know about the new R21 malaria vaccine.

April 13, 2023 - Professor Adrian Hill, Chief investigator, R21/Matrix-M program, and Director of the University of OxOxford'senner Institute at the Nuffield Department of Medicine, commented in a press release, 'T'is marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most.'

April 13, 2023 - The Managing Director/CEO of DEK Vaccines Limited, Dr. Kofi Nsiah-Poku, said, "D"K Vaccines Limited, an upcoming vaccines manufacturing factory in Accra, Ghana, is thankful for the support of the Government of Ghana through the Vaccines Manufacturing Committee and Ghana FDA, who have been first in the world to approve the R21/Matrix-M malaria vaccine."

December 1, 2022 - The Lancet Infectious Disease published: Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after two years follow-up in children in Burkina Faso: a phase 1/2b randomized controlled trial.

November 3, 2022 - MedpageToday reported the malaria vaccine candidate demonstrated an overall efficacy of 75% in children with no serious safety concerns.

September 29, 2022 - The WHO launches a new initiative to stop the spread of invasive malaria vectors in Africa.

September 8, 2022 - Professor Adrian Hill, the University of Oxford'sirector of the Jenner Institute, Lakshmi Mittal and Family Professor of Vaccinology, and co-author of the research paper, said: 'We are delighted to find that a standard four-dose immunization regime can now, for the first time, reach the high efficacy level over two years that has been an aspirational target for malaria vaccines for so many years.'

September 7, 2022 - The peer-review journal The Lancet published the findings from a booster dose clinical trial - These findings show that R21/Matrix-M has again reached the WHO-specified efficacy goal of 75% or greater over 24 months in the target population of African children. And in children who received R21 with the higher dose of Matrix-M adjuvant, efficacy was 80% at 12 months following the booster vaccination.

April 30, 2021 - BMC article: The new vaccine, R21, is very similar to RTS,S/AS01, in that it still contains the central repeat and the C-terminus of the circumsporozoite protein (CSP) fused to the N-terminal end of HBsAg. However, in contrast with RTS,S/AS01, does not contain the HBsAg in monomer form, only as fusion protein moieties, providing more surface for the CSP on the virus-like particle, making for a more specific immune response. In addition, R21 is mixed with a different saponin-based adjuvant called Matrix-M, produced by Novavax.

April 20, 2021 - The Lancet published a non-peer-reviewed study: High Efficacy of a Low Dose Candidate Malaria Vaccine, R21 in 1 Adjuvant Matrix-M™, with Seasonal Administration to Children in Burkina Faso. Interpretation: R21/Matrix-M appears safe and immunogenic in African children and demonstrates promising high-level efficacy.

May 7, 2015 - A vaccine against malaria developed at Oxford University'senner Institute has shown promising results in its first field trial. The results are published today in the journal Science Translational Medicine.

R21 / Matrix-M Malaria Vaccine Clinical Trials

R21/Matrix-M Malaria Vaccine candidate continues progressing through the Clinical Trial process.

The Phase1/2 trial was funded by the EDCTP2 program supported by the European Union (grant number RIA2016V-1649-MMVC) and the Wellcome Trust and NIHR Oxford Biomedical Research Centre. Oxford researchers and their partners reported from a Phase IIb trial that a booster dose of R21/Matrix-M at one year following a primary three-dose regime maintained high efficacy against malaria and continued to meet the World Health OrOrganization'salaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase-IIb trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the significant phase III trial also show high levels of efficacy and a reassuring safety profile.

A Phase 3 trial assesses large-scale safety and efficacy in 4,800 children 5-36 months across Burkina Faso, Kenya, Mali, and Tanzania.