The Ghana Food and Drugs Authority (FDA) has announced that the malaria vaccine created by the University of Oxford in the UK has been granted regulatory approval for use in Ghana.
The announcement by the FDA on Thursday evening (April 13, 2023) follows an earlier one by the University of Oxford.
The vaccine was manufactured by the Serum Institute of India Pvt. Ltd submitted through the local agent DEK Pharmaceutical Ghana.
Ghana becomes the first country to have been given the authorization to market the vaccine.
The FDA says the approval was granted following an extensive series of reviews and thorough peer reviews of the non-clinical and clinical quality parts of the vaccine product development dossier.
The Chief Executive of the FDA, Dr. Mimi Delese Darko made the announcement at a press briefing in Accra Thursday evening.
FDA on March 28, 2023, granted approval to the vaccine for use for the immunization of children aged five months to 36 months against malaria caused by plasmodium falciparum.
The vaccine is a clear, colorless mildly turbid solution for injection, which is stored between two and eight degree Celsius (refrigerator) and has a shelf-life of 24 months.
Dr (Mrs) Darko explained that the evaluation and approval process considered the safety, immunogenicity, and efficacy data generated from five main clinical trials conducted in the United Kingdom, Kenya, Mali, Burkina Faso, and Tanzania.
“Thus, the approval of the vaccine was based on a satisfactory evaluation outcome of the quality, safety, and efficacy data submitted to the FDA.
“The evaluation of the submission concluded that the benefit of the vaccine significantly outweighs the risk associated with the use of the vaccine,” she explained.
She said the vaccine had the potential to reduce children under five years mortality caused by malaria in Africa.
The FDA CEO explained that the manufacturer of the vaccine chose Ghana FDA to subject its application for formal marketing authorization because of the track record of the authority.
She cited some of the track records including the fact that the FDA “is a Maturity Level 3 National Regulatory Authority for medicines and vaccines regulatory oversight and has extensive competencies in evaluating quality, nonclinical, and clinical parts of the product”.