Ghana has become the first country in the world to approve using the R21/Matrix-M malaria vaccine, developed by the University of Oxford and produced by the Serum Institute of India.
Utilising the adjuvant technology from Novavax, Ghana’s Food and Drugs Authority granted a license to use the malaria vaccine R21/Matrix-MTM, created at the University of Oxford and produced and scaled up by Serum Institute of India PvT Ltd (SIIPL).
This represents the first regulatory approval for the R21/Matrix-M malaria vaccine to be used in any country, which is a crucial step in reducing over half a million malaria-related deaths each year and improving health outcomes for millions of people all over the African continent and beyond.
The Serum Institute of India, the company that produces the vaccine, has acknowledged their readiness to produce vaccine doses swiftly and in large quantities, with a yearly production capacity that might reach more than 200 million doses.
The manufacturing and commercialization license holder for the vaccine, SIIPL, was informed by the FDA Ghana of the successful registration, according to a statement by a Senior Associate, Sofija Dilas.
The vaccine has been given approval for use in children between the ages of 5 and 36 months, who are most at risk of dying from malaria. It is expected that this important first step will make it possible for the vaccine to effectively fight malaria in children in Ghana and other African countries.
Prof. Adrian Hill, Director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine and Chief Investigator of the R21/Matrix-M program, said, “This marks a culmination of 30 years of research at Oxford into malaria vaccines with the design and provision of a high efficacy vaccine that can be supplied at an adequate level to the countries who are in need of it most.
“I applaud our outstanding clinical trial partners in Africa who produced the dataset demonstrating the vaccine’s safety and effectiveness in children. Our partnership with the Serum Institute of India has been valuable to the successful extremely large-scale manufacturing and rapid development of the COVID-19 vaccine from Oxford-AstraZeneca.
The R21/Matrix-M malaria vaccine, according to its manufacturers, is a low-dose vaccine that can be produced in large quantities at a cheap cost, allowing for the distribution of hundreds of millions of doses to African nations with high malaria burdens.
The R21/Matrix-M vaccine was discovered to have been created and developed at the University of Oxford. It has undergone clinical trials in the UK, Thailand, and several countries in Africa, including an ongoing phase III trial with 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania. The end of the year is anticipated for the release of the trials’ results.
Adar Poonawalla, CEO of the Serum Institute of India Pvt Ltd., stated that malaria is a life-threatening disease that disproportionately affects the world’s most vulnerable population and is still a top cause of mortality in children.
Dr Kofi Nsiah-Poku, Managing Director/CEO of DEK Vaccines Limited, stated, “DEK Vaccines Limited, an upcoming vaccines manufacturing factory in Accra, Ghana, is grateful for the support of the Government of Ghana through the Vaccines Manufacturing Committee and Ghana FDA, who was the first in the world to approve the R21/Matrix-M malaria vaccine.”
“We are focused on assisting the Serum Institute of India in having their vaccines manufactured at DEK once the DEK Factory is completed.” Additionally, the DEK regulatory team will assist the Serum Institute with registering the R21/Matrix-M malaria vaccine in the other countries in Africa and making it available to African children,” Nsiah-Poku stated.
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