High efficacy malaria vaccine delivered by Oxford University and Serum Institute of India

The University of Oxford has developed a highly effective malaria vaccine that has been licensed for use in Ghana by the African Food and Drugs Authority. Manufactured and scaled up by the Serum Institute of India (SII), the R21/Matrix-M vaccine has been approved for use in children aged 5 to 36 months, who are at the highest risk of death from malaria.

This marks the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country. The vaccine is a low-dose vaccine that can be manufactured at a 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.

The vaccine was initially designed and developed at the University of Oxford and has undergone clinical trials in the UK, Thailand, and several African countries. The vaccine leverages Novavax’s adjuvant technology, the Matrix-M, which enhances the immune system response, making it more potent and more durable.

Professor Adrian Hill, Chief investigator of the programme and Director of Oxford University’s Jenner Institute at the Nuffield Department of Medicine, said that 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 an adequate scale to the countries that need it most.

He also highlighted that the partnership with the Serum Institute of India has been key to successful large-scale manufacturing and rapid development, as was the case with the Oxford-AstraZeneca COVID-19 vaccine.

Adar Poonawalla, CEO of the Serum Institute of India, said that 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. He expressed that the licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in their efforts to combat malaria around the world.

SII has already established potential manufacturing capacities of more than 200 million doses annually. The scientists behind the project see this as a critical step towards reducing over half a million malaria-related deaths annually and improving the health outcomes of millions of people in Africa and beyond.

Results from ongoing Phase III trials in Burkina Faso, Kenya, Mali, and Tanzania that has enrolled 4,800 children are expected to be reported later this year.