Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.

Children between the ages of five and  36 months are at highest risk of death from malaria. The World Health Organization (WHO) says that in 2021, children under five years accounted for approximately 80% of malaria deaths in Africa, a continent disproportionately affected by the disease.  The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine, is yet to recommend Oxford’s R21 vaccine.

R21 contains Matrix-M, a saponin-based adjuvant from Novavax which makes the vaccine more potent and durable by enhancing immune system response. Observers expect this will allow mass-scale manufacturing at modest cost, thereby turning the tide against malaria.

Data reported from a Phase IIb R21 trial demonstrated that a booster dose at one year following a primary three-dose regime maintained high efficacy against malaria and also met the WHO’s 75% efficacy target.  Recent data from an ongoing Phase III trial, which has enrolled 4,800 children in Burkina Faso, Kenya, Mali and Tanzania, show high levels of efficacy and a reassuring safety profile, according to the University of Oxford.

Developing a malaria vaccine has been challenging because of the issue of growing resistance to certain artemisinin-based combination therapies (ACTs), and changes in mosquito biting behaviour to avoid insecticides. Not least is vaccine inequality – the accessibility to drugs and therapies across the African nations is far behind developed countries elsewhere.

“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. Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult,” said Serum Institute of India’s CEO Adar Poonawalla.

“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,” said Professor Adrian Hill, director of the Jenner Institute at the Nuffield Department of Medicine at the University of Oxford.