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).
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: “Malaria is a life-threatening disease that disproportionately affects the most vulnerable populations in our society and remains a leading cause of death in childhood. Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult.
She added: “At the Serum Institute of India, we are committed to our vision of Health for All and ensuring equitable access to vaccines for people around the world.”
Professor Adrian Hill, director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine, reflected: “This marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most. I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children.”
John Jacobs, president and chief executive officer at Novavax, concluded: “We’re thrilled that Novavax’s Matrix-M adjuvant has contributed to the success of this promising and much-needed malaria vaccine. It is our intension to unlock the potential of our adjuvant, both in the near term and over time, to continue to improve public health.”
By John Pinching
Source: pharmatimes.com
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