The vaccine – which is manufactured by the Serum Institute of India and uses Novavax’ adjuvant tech – has been licensed for use in Ghana by the country’s Food and Drugs Authority. The vaccine has been approved for use in children aged 5 to 36 months, the age group at highest risk of death from malaria.
While developing an effective malaria vaccine has proved a challenge for decades, the R21 vaccine meets WHO goals of at least 75% efficacy, and can be administered in low doses that can be manufactured at mass scale and modest cost.
77% efficacy
The R21/Matrix-M vaccine was designed and developed at the University of Oxford and has undergone clinical trials in the UK, Thailand, and several African countries, including an ongoing phase III trial in Burkina Faso, Kenya, Mali and Tanzania that has enrolled 4,800 children. Results from these trials are expected to be reported later this year.
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%.
GlaxoSmithKline’s Mosquirix (RTS,S/AS01) gained WHO prequalification in September last year and is used in sub-Saharan Africa and other regions with moderate to high transmission. Its efficacy was 56% in children aged 5-17 months in Phase 3 trials.
Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile, add the partners.
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 is used in Novavax’s COVID-19 vaccine and is a component of other development-stage vaccines.
The Serum Institute of India Pvt Ltd (SIIPL) has provided vaccine and sponsored Phase III licensure clinical trials. It has already established potential manufacturing capacities of more than 200 million doses annually.
Professor Adrian Hill, Chief investigator, R21/Matrix-M program, and Director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine, said: "This [authorization] 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."
