The R21/Matrix-M malaria vaccine has been recommended for use by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG).
Developed by The University of Oxford and the Serum Institute of India, leveraging Novavax’s adjuvant technology, R21/Matrix-M malaria vaccine demonstrates high efficacy with a reassuring safety profile.
It is an easily deployable vaccine that can be manufactured at mass scale and modest cost, enabling hundreds of millions of doses to be supplied to countries which are suffering a significant malaria burden.
The Serum Institute of India has already established production capacity for 100 million doses per annum, which will be doubled over the next two years.
The developers expect additional regulatory approvals will follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out next year.
The vaccine was approved in Ghana in April.
Professor Sir Adrian Hill, Director of The Jenner Institute, & Lakshmi Mittal and family Professor of Vaccinology, University of Oxford said: “The R21/Matrix-M malaria vaccine has been shown to be safe and highly effective across multiple clinical studies and is now approved as WHO policy for widespread use. The vaccine is easily deployable, cost effective and affordable, ready for distribution in areas where it is needed most, with the potential to save hundreds of thousands of lives a year.”
Phase III trial data
The WHO recommendation was based on pre-clinical and clinical trial data which showed good safety and high efficacy in four countries, making it the world’s second-ever WHO recommended vaccine for preventing malaria in children.
In a pivotal large-scale Phase III clinical trial, 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%.
Significantly higher vaccine-induced antibody titres were observed in the five to 17-month age group compared with 18-36-month-olds. The younger age group, in whom this vaccine is most likely to be widely deployed, showed the highest 12-month vaccine efficacy at both seasonal, 79% and standard sites, 75%.
In a previous Phase IIb clinical trial conducted in Burkina Faso, Oxford researchers and their partners reported two year efficacy and showed that that a booster dose of R21/Matrix-M maintained high efficacy against malaria and continued to meet the World Health Organization’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy.
Large-scale vaccine production
The R21/Matrix-M vaccine is licensed to the Serum Institute of India, the world’s largest vaccine manufacturer and long-term partner of Oxford University. The Serum Institute has already established production capacity for 100 million doses per annum, which will be doubled over the next two years.
Adar Poonawalla, CEO of the Serum Institute of India, said: “For far too long, malaria has threatened the lives of billions of people across the globe, disproportionately affecting the most vulnerable amongst us. This is why the WHO recommendation and approval of the R21/Matrix-M vaccine marks a huge milestone on our journey to combat this life-threatening disease, showing what exactly can be achieved when the public and private sector, scientists and researchers, all work together towards a shared goal.”
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.