This marks the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country. The successful registration was notified to SIIPL by the FDA Ghana. SIIPL is the manufacturing and commercialisation license holder for the vaccine. The vaccine has been approved for use in children aged 5 to 36 months, the age group at highest risk of death from malaria. It is hoped that this first crucial step will enable the vaccine to help Ghanaian and African children to effectively combat 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.
Professor 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.’