New Delhi: Serum Institute of India on Monday said the World Health Organisation (WHO) has approved a malaria vaccine, paving the way for the global roll-out of the world’s second such vaccine.
The recommendation is 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, SII said in a statement.
The R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India (SII), leveraging Novavax’s adjuvant technology, has been recommended for use by the WHO.
Hundreds of millions of doses of this vaccine, R21/Matrix-M, are to be supplied to countries that are suffering a significant malaria burden, the University of Oxford website said. The Serum Institute of India has already established a production capacity for 100 million doses per annum, which will be doubled over the next two years, it added.
Adar Poonawalla (pictured), chief executive officer 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.’’ In a statement, he also said: ‘’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.”
Serum’s effort is to scale up the vaccine production to ensure that it is accessible to those who need it the most, according to Poonawalla.
At this point, it’s not known when the vaccine will be available in 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 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. 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 WHO recommendation is required for UNICEF to procure and GAVI to purchase the vaccine.
R21/Matrix-M malaria vaccine marks the culmination of 30 years of malaria vaccine research at the University of Oxford’s Jenner Institute.
The efficacy of the vaccine over 12 months was 75 per cent at sites with high seasonal malaria transmission and 68 per cent 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 per cent.
Adrian Hill, director of the Jenner Institute, and 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.”
