The R21/Matrix-MTM malaria vaccine developed by the University of Oxford and the Serum Institute of India has been recommended for use by the World Health Organisation (WHO), paving the way for its global roll-out.
The WHO made the announcement after the vaccine, developed with support from the NIHR Oxford Biomedical Research Centre (BRC), underwent a rigorous, detailed scientific review by the WHO’s independent advisory body, the Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG) and was found to meet the required safety, quality and effectiveness standards.
The 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.
The vaccine, which uses Novavax’s adjuvant technology to enhance the body’s immune response, was developed by the Jenner Institute at Oxford University and 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-MTM malaria vaccine has been licensed for use in Ghana, Nigeria and Burkina Faso. In combination with public health measures such as the use of insecticide-treated bed nets, this vaccine can help save and improve the lives of millions of children and their families.
Professor Sir Adrian Hill (pictured left), Director of The Jenner Institute, 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.”
The R21/Matrix-M vaccine 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 vaccine was well tolerated with a good safety profile. The efficacy of the vaccine over 12 months was 75% at sites with high seasonal malaria transmission and 68% in places with more perennial transmission.
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%.
A significantly higher vaccine-induced concentration of antibodies was 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 (75%) sites.
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 WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed earlier results from the same trial reporting one-year efficacy of 77%.
The Phase III results improve understanding of how vaccine efficacy varies with age and across regions in relation to transmission intensity and seasonality. Further studies are also exploring optimal dosing schedules and tracking long-term immune response.
Dr Mehreen Datoo, Academic Clinical Fellow in Infectious Diseases & Microbiology at The Jenner Institute, said: “The University of Oxford has one of the most active malaria vaccine programmes in the world, with thanks to a network of global collaborators. Today’s achievement would not be possible without the efforts of our international partners, their incredible field teams, and of course, the participants and their caregivers.
“This is a significant milestone in the fight against malaria but there is still more to do – we are already working on new vaccine candidates to target other malaria parasites and clinical trials focussed on eradication of malaria.”
Dr Lisa Stockdale, Senior Immunologist at The Jenner Institute, said: “Today’s news is testament to the work of our dedicated team and means we have another tool with which to fight this disease that kills over half a million people every year. However, further work is critical to establish not just that the vaccine works, but to understand more about how it works, and apply that knowledge to future vaccines.’
The R21/Matrix-M malaria vaccine 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 vaccine is licensed to the Serum Institute of India, the world’s largest vaccine manufacturer and a long-term partner of Oxford University. The Institute has already established production capacity for 100 million doses per year, 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.
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.