Ghana becomes 1st country to approve Oxford malaria vaccine for use

By Enoch Fiifi Forson

ACCRA, Ghana (AA) – Ghana has become the first country in the world to receive regulatory approval to market the malaria vaccine developed by the University of Oxford.

The announcement was made by the Food and Drugs Authority (FDA) in Ghana on Thursday.

The vaccine was manufactured by the Serum Institute of India Pvt. Ltd and submitted through the local agent DEK Pharmaceutical Ghana.

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 vaccine has been approved for use for the immunization of children aged 5 months to 36 months against malaria caused by plasmodium falciparum.

Experts say the vaccine will help fight malaria which infects millions of people every year and kills hundreds of thousands, especially children, in Africa.

FDA Chief Executive Mimi Delese Darko in a press briefing explained that the evaluation and approval process considered the safety, immunogenicity, and efficacy data generated from five main clinical trials conducted in the UK, 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.

Darko also highlighted that the vaccine had the potential to reduce malaria-related mortality in children under 5 in Africa.