The Food and Drugs Authority (FDA) has given the green light to the R21 Malaria vaccine which was developed by the Oxford University in the United Kingdom and manufactured by the Serum Institute of India Pvt. Ltd, submitted through the local agent DEK.

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.

Briefing the media on Thursday, April 13, 2023, the CEO of FDA, Dr. Delese Darko says they have approved the vaccine’s use in children between the ages of five months to three years.

“The R21 malaria vaccine has been approved for use for the immunization of children aged 5 months to 36 months against Malaria caused by plasmodium Falciparum”.

The vaccine is a clear, colourless to mildly turbid solution for injection, which is stored between 2 and 8°C (refrigerator) and has a shelf-life of 24 months.

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.

The CEO further explained that, the reason the manufacturers chose to select Ghana for the vaccine’s introduction is “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”, she added.