The Food and Drugs Authority (FDA) has approved the R21 malaria vaccine for use for the immunization of children aged 5 months to 36 months against Malaria caused by Plasmodium Falciparum.
The vaccine, according to the FDA in a statement dated Thursday, April 13, 2023, 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.
“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. T
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 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.”
It added “the approval of the vaccine was based on a satisfactory evaluation outcome of the quality, safety and efficacy data submitted to the FDA,” and noted the evaluation of the submission concluded that the “benefit of the vaccine significantly outweighs the risk associated with the use of the vaccine.”
According to the regulatory body, the vaccine also has the potential to reduce children under 5 years’ mortality caused by malaria in Africa.
FULL STATEMENT
