The vaccine was developed by Oxford University and manufactured by the Serum Institute of India.
The FDA says after a thorough evaluation of the quality, efficacy, and safety of the vaccine, they realized that the benefits far outweigh the risks.
Briefing the media on Thursday, the CEO of the FDA, Dr. Delese Darko says they have approved the vaccine’s use in children between the ages of five months to three years.
“On March 28 this year, the FDA granted approval to R21 malaria vaccine manufactured by the Serum Institute of India which was submitted through the local agent, DEK Pharmaceuticals Ghana. The approval was granted following extensive series of reviews and peer reviews of the clinical, non-clinical, and quality parts of the vaccine development procedure.
“The vaccine has been approved for use for the immunization of children between five months to thirty-six months. It is a colourless to mild turbid solution for injection, and it is supposed to be stored in a refrigerator and has a shelf life of twenty-four months. Our evaluation indicated that the vaccine has the potential to reduce infant mortality caused by malaria in Africa.”
She further explained the reason the manufacturers chose to select Ghana for the vaccine’s introduction.
“Ghana was chosen 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.”
