Pune: 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 Organization (WHO) after meeting safety, quality, and effectiveness standards.
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. 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.
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 a 1-year efficacy of 77%.
The Phase III results improve understanding of how vaccine efficacy varies with age and across regions about transmission intensity and seasonality. Further studies are also exploring optimal dosing schedules and tracking long-term immune responses.
