Serum Institute-Oxford University malaria vaccine bags WHO recommendation

Following 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), the R21/Matrix-M malaria vaccine has been recommended for use. 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 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-M malaria vaccine has been licensed for use in Ghana, Nigeria and Burkina Faso.

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 vaccine was well tolerated with a good safety profile. The efficacy of the vaccine over 12 months was 75% (95% CI 71-79; p<0.001) at sites with high seasonal malaria transmission and 68% (61-74; p<0.001) 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% (70-77; p<0.001).

Significantly higher vaccine-induced antibody titres were observed in the 5–17-month age group compared with 18–36-month-olds (p<0.0001). 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% (73-84, p<0.001), and standard sites, 75% (65-83, p<0.001).

In a previous Phase IIb clinical trial conducted in Burkina Faso, Oxford researchers and their partners reported 2 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. This followed earlier results from the same trial reporting 1 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.

Prof. 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.’

Dr Mehreen Datoo, Academic Clinical Fellow in Infectious Diseases & Microbiology at The Jenner Institute, University of Oxford 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, The Jenner Institute, University of Oxford said: 'Today’s news is testament to the work of our small but 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.’

John C. Jacobs, President and Chief Executive Officer, Novavax said, 'This WHO designation highlights the meaningful contribution that R21/Matrix-M is likely to have in accelerating and expanding access to a safe, efficacious and potentially life-saving vaccine to control malaria – a disease that disproportionately impacts children. Novavax celebrates the importance of this milestone and is proud of the role of our saponin-based Matrix-M adjuvant plays in the R21/Matrix-M malaria vaccine, which has now met the rigorous standards required for WHO recommendation.'