The announcement by the FDA Thursday evening (April 13, 2023) follows an earlier one by University of Oxford.

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

Ghana becomes the first country to have been given the authorisation to market the vaccine.

The FDA says 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 Chief Executive of the FDA, Dr Mimi Delese Darko made the announcement at a press briefing in Accra Thursday evening.

The FDA on March 28, 2023 granted approval to the vaccine for use for the immunization of children aged five 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 two and eight degree Celsius (refrigerator) and has a shelf-life of 24 months.

Dr (Mrs) Darko explained 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.

“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. 

She said the vaccine had a potential to reduce children under five years mortality caused by malaria in Africa.

The FDA CEO explained that the manufacture of the vaccine, chose Ghana FDA to subject its application for formal marketing authorization because the track record of the authority.

She cited some of the track record to include the fact that the 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”.

Dr Darko added that the FDA was a Regional Centre of Regulatory Excellence (RCORE) in clinical trial oversight, marketing authorisation and safety monitoring since 2014. 

She added that the authority had built the capacity of 150 participants and over 23 countries in Africa.