According to Dr. Delese Darko, the FDA’s Chief Executive Officer, Ghana was selected by the manufacturers of the malaria vaccine because the country has a Food and Drugs Authority (FDA) that is a Maturity Level 3 National Regulatory Authority for the regulation of pharmaceuticals and vaccines.
She further stated that the FDA had extensive competencies in evaluating the quality of clinical and non-clinical parts of a product.
“We are also a regional centre of regulatory excellence with clinical trial oversights,” she said at a press conference in Accra on Thursday, April 13.
Ghana became the first country in the world on Thursday, April 13 to approve a new malaria vaccine from Oxford University.
The FDA Boss said “On March 28 this year, the FDA granted approval to R21 malaria vaccine manufactured by the Serum Institute of India which was submitted through the local agent, DEK Pharmaceuticals Ghana.
“The approval was granted following extensive series of reviews and peer reviews of the clinical, non-clinical, and quality parts of the vaccine development procedure.
“The vaccine has been approved for use for the immunization of children between five months to thirty-six months.
“It is a colourless to mild turbid solution for injection, and it is supposed to be stored in a refrigerator and has a shelf life of twenty-four months. Our evaluation indicated that the vaccine has the potential to reduce infant mortality caused by malaria in Africa.”
“Ghana was chosen because the FDA is a level three maturity national regulatory authority for medicines and vaccines and regulatory oversights and has extensive competencies in evaluating the quality of clinical and non-clinical parts of a product. We are also a regional centre of regulatory excellence with clinical trial oversights.”