FDA grants approval of R21 Malaria Vaccine in Ghana
The Food and Drugs Authority (FDA) has granted the approval of a new R21 Malaria Vaccine in Ghana.
According to the FDA, the approval was granted following an extensive series of reviews and thorough peer-reviews of the non-clinical and clinical quality part of the vaccine product development dossier.
Addressing Journalists in Accra on Thursday, the Chief Executive Officer (CEO), Dr. Delese Mimi Darko said "On the 28th March 2023, the Food and Drugs Authority (FDA) granted approval 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"
Dr. Darko added that 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.
She stressed that 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 CEO also mentioned 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.
Dr. Delese Mimi Darko hinted that 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. Again, the vaccine has a potential to reduce children under 5 years mortality caused by malaria in Africa"
The CEO further explained that the manufacture of the vaccine, Serum Institute, chose Ghana FDA to subject its application for formal marketing authorization.
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.
"FDA is a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trial Oversight, Marketing Authorization and Safety Monitoring since 2014"
"The Authority has built the capacity of 150 participants and over 23 countries in Africa"
"The Authority has an in-house expert that has provided advice on a similar vaccine under EMA Article 58"
The CEO added that the FDA granted EUA to COVID-19 vaccines concurrently with WHO Emergency Use Listing to most of the COVID-19 vaccines during the COVID-19 pandemic.
Within the sub region, Dr. Darko stated that the Authority leads the regional collaborating efforts on vaccines and biological products and chair the Experts Committee.
"FDA chairs the Steering Committee of the Africa Vaccine Regulatory Forum. The FDA Quality Control laboratory is ISO 17025 accredited, the biggest testing scope under one roof in Africa and WHO prequalified"
Dr. Delese Mimi Darko however revealed that the status of the FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future.
Story by: Joshua Kwabena Smith