The Food and Drugs Authority (FDA) has approved a new R21 malaria vaccine to help fight the disease, a major cause of mortality among children under five in African.
The R21 malaria vaccine is to be used for children aged between five to 36 months against malaria caused by Plasmodium Flaciparum.
The Chief Executive Officer of the FDA, Mrs Delese Mimi Darko disclosed this at a press conference in Accra on Thursday.
She said the FDA on March 28, this year granted approval to the vaccine which was developed by the Oxford University in the United Kingdom and manufactured by the Serum Institute of India Pvt. limited, 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.
“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,” she added.
Mrs Darko stated 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.
She said the approval of the vaccine was based on a satisfactory evaluation outcome of the quality, safety and efficacy data submitted to the FDA.
Mrs Darko said the evaluation of the submission concluded that the benefit of the vaccine significantly outweighs the risk associated with the use of the vaccine.
She said the manufacture of the vaccine, Serum Institute, chose Ghana FDA to subject its application for formal marketing authorisation for the following reasons:
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.
Mrs Darko stated that FDA is a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trial and has an in-house expert that has provided advice on a similar vaccine under EMA Article 58.
She gave the assurance that the vaccines were safe and urged parents to get their children vaccinated when the programme commence to help reduce children from getting infected with malaria.
In attendance were the Board Chairman of the FDA, Dr Sammy Ohene, Mr Seth Seneke, Deputy CEO for Health Product and Technology Division, Mr Eric Kakari Boteng, Director for Centre for Laboratory for Research and Mrs Yvonne Nkrumah, Director Corporate Service, all of the FDA.
BY ANITA NYARKO-YIRENKYI
