Ghana, has become the first African nation worldwide to grant approval for the use of the R21/Matrix-M malaria vaccine, developed by the University of Oxford and manufactured by the Serum Institute of India (SIIPL), with the support of Novavax’s adjuvant technology, as confirmed by Ghana’s Food and Drugs Authority.
This significant milestone is expected to contribute to the reduction of over half a million malaria-related deaths each year and improve health outcomes for millions of people across Africa and beyond, as it marks the first regulatory clearance for the R21/Matrix-M vaccine in any country.
The Serum Institute of India, the vaccine’s manufacturer, has expressed readiness to produce the vaccine at a large scale, with potential manufacturing capacities exceeding 200 million doses annually. The approval covers the use of the vaccine in children aged 5 to 36 months, who are at the highest risk of malaria-related deaths.
The Chief Investigator of the R21/Matrix-M program, Prof. Adrian Hill from the University of Oxford, acknowledged the culmination of 30 years of malaria vaccine research and praised the clinical trial partners in Africa for generating safety and efficacy data.
The R21/Matrix-M vaccine is designed to be low-dose, cost-effective, and scalable, with the aim of supplying hundreds of millions of doses to malaria-burdened African countries. The vaccine has undergone clinical trials in various countries, including an ongoing phase III trial in Burkina Faso, Kenya, Mali, and Tanzania, with results expected to be reported later this year.
Adar Poonawalla, CEO of the Serum Institute of India, emphasized the urgency of addressing malaria, a life-threatening disease that disproportionately affects vulnerable populations, while Dr. Kofi Nsiah-Poku, MD/CEO of DEK Vaccines Limited in Ghana, expressed gratitude for the government’s support and pledged to assist the Serum Institute in registering the vaccine in other African countries and making it available to African children, once DEK Factory is completed.