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.
Phase III trial
The Indian company added that the vaccine has recently reached the primary one-year endpoint in a pivotal large-scale Phase III clinical trial — funded mainly by the Serum Institute of India, with Oxford University as the regulatory sponsor — including 4,800 children across Burkina Faso, Kenya, Mali and Tanzania. The Phase III trial results are under peer review before publication.
The Serum institute added that the efficacy of the vaccine over 12 months was 75% at sites with high seasonal malaria transmission and 68% at the sites with more perennial transmission using standard age-based administration.
“There was some waning of efficacy over the first year of follow-up at both seasonal and perennial transmission sites, but a booster dose restored efficacy at the seasonal sites with a vaccine efficacy over 18 months of 74%,” it added.
Adar Poonawalla, CEO of the Serum Institute of India, said his company looks forward to scaling up the vaccine production to ensure that it is accessible to those who need it the most.
John C. Jacobs, president and CEO, Novavax, added that this vaccine is likely to accelerate and expand access to a safe, efficacious and potentially life-saving vaccine to control malaria — a disease that disproportionately impacts children.
