By Linda Naa Deide Aryeetey
Accra, April 13, GNA – The Food and Drugs Authority (FDA) has approved R21, a new malaria vaccine from the Oxford University, for use in children aged five months to three years.
This makes Ghana the first country in the world to approve the vaccine, which has been described as a “world-changer” by the scientists who developed it.
The FDA’s approval of the vaccine comes ahead of the World Health Organization’s (WHO) assessment of the safety and effectiveness of the vaccine.
This is the first time a regulatory authority in Africa has assessed and approved a vaccine ahead of the WHO.
The WHO is also considering approving the vaccine, with other African countries also studying it.
Mrs Delese Mimi Darko, Chief Executive Officer of the Food and Drugs Authority (FDA), said the Authority had granted approval to the R21 malaria Vaccine.
It 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.
She said 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.
Mrs Darko said the R21 malaria vaccine had been approved for use for the immunisation of children aged five months to 36 months against malaria caused by Plasmodium Falciparum.
“The vaccine is a clear, colorless to mildly turbid solution for injection, which is stored between two and eight degree Celsius (refrigerator) and has a shelf-life of 24 months,” she said.
The FDA CEO said 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.
“The evaluation of the submission concluded that the benefit of the vaccine significantly outweighs the risk associated with the use of the vaccine, again the vaccine has a potential to reduce children under five years mortality caused by malaria in Africa,” she said.
Mrs Darko said the manufacturer of the vaccine, Serum Institute, chose Ghana FDA to subject its application for formal marketing authorisation because FDA was a Maturity Level 3 National Regulatory Authority for medicines and vaccines.
She said the FDA’s regulatory oversight had extensive competencies in evaluating quality, nonclinical and clinical parts of the product.
She said Ghana was selected because the FDA was a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trial Oversight, Marketing Authorisation and Safety Monitoring since 2014 and that the Authority had built the capacity of 150 participants and over 23 countries in Africa.
GNA