A malaria vaccine – R21/Matrix-M – developed by University of Oxford and Serum Institute of India PvT Ltd (SIIPL) has been licensed for use in Ghana by its Food and Drugs Authority (FDA Ghana)....CONTINUE READING
The vaccine, which leverages adjuvant technology from Novavax, and is manufactured by SIIPL, has been awarded national licensure for use across Ghana.
It becomes the first clearance for R21/Matrix-M malaria vaccine for use in any specific country. The vaccine has been approved for use among children aged from five to 36 months – the demographic at highest risk of death from the disease.
The vaccine is a low-dose vaccine that can be manufactured at mass scale and reasonable cost, enabling hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden.
Furthermore, it has already demonstrated high levels of efficacy and safety in phase 2 trials – including those children who received a booster dose of R21/Matrix-M at one year, following a primary three-dose regime.
It is hoped that the regulatory milestone will enable the vaccine to help Ghanaian and African children to combat malaria.
Adar Poonawalla
, chief executive officer at the Serum Institute of India Pvt Ltd, was in no doubt about the impact that the vaccine could make;
She added;
Professor Adrian Hill
, director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine, reflected;
