The R21/Matrix-M malaria vaccine has received regulatory clearance for use in Ghana by the country’s Food and Drugs Authority, making it the first country to approve the vaccine.
R21/Matrix-M was developed by the University of Oxford and manufactured and scaled up by the Serum Institute of India (SIIPL), leveraging Novavax’s adjuvant technology.
The vaccine has been approved for use in children aged five to 36 months, the age group at highest risk of death from malaria.
The R21/Matrix-M vaccine has demonstrated high levels of efficacy and safety in Phase II trials, including amongst children who received a booster dose of R21/Matrix-M at one year following a primary three-dose regime.
Prof Adrian Hill, Chief investigator, R21/Matrix-M programme, and Director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine, said: “This 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.
“I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children. As with the Oxford-AstraZeneca Covid-19 vaccine, our partnership with the Serum Institute of India has been key to successful very large-scale manufacturing and rapid development.”
Clinical trial data
The R21/Matrix-M malaria vaccine is a low-dose vaccine that can be manufactured at mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden.
Oxford researchers and their partners last year 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 Organization’s Malaria 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 large Phase III trial also show high levels of efficacy and a reassuring safety profile.
How the vaccine works
The vaccine contains Novavax’s Matrix-M, a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s Covid-19 vaccine and is a key component of other development-stage vaccines.
Adar Poonawalla, CEO of the Serum Institute of India, said: “Malaria is a life-threatening disease that disproportionately affects the most vulnerable populations in our society and remains a leading cause of death in childhood.
“The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives.”
Photo credit: Tom Wilkinson, University of Oxford.