With the approval by WHO, additional regulatory approvals are expected to follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out as early as next year
The R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India, leveraging Novavax’s adjuvant technology, has been recommended for use by the World Health Organisation (WHO) after meeting required safety, quality and effectiveness standards, on Monday.
Following a detailed scientific review by the WHO’s independent advisory body, the Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG), the R21/Matrix-M malaria vaccine has been recommended for use, noted a release issued by the Serum Institute of India. With the approval and recommendations by the WHO, additional regulatory approvals are expected to follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out as early as next year.
The Serum Institute has already established production capacity for 100 million doses per annum, which will be doubled over the next two years. This scale of production is critical because vaccinating those at high risk of malaria will be important in stemming the spread of disease, as well as protecting the vaccinated.
The Matrix-M component is a proprietary saponin-based adjuvant from Novavax, which is licensed to the Serum Institute for use in endemic countries, while Novavax retains commercial rights in non-endemic countries.
The vaccine was developed by the Jenner Institute at Oxford University and the Serum Institute of India with support from the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB).
To date the R21/Matrix-M malaria vaccine has been licensed for use in Ghana, Nigeria and Burkina Faso.
According to information released by the Serum Institute, the WHO recommendation was based on pre-clinical and clinical trial data which showed good safety and high efficacy in four countries, at sites with both seasonal and perennial malaria transmission, making it the world’s second-ever WHO recommended vaccine for preventing malaria in children.