malaria vaccine

FDA approves R21 malaria vaccine for children aged 5 months to 36 months

The FDA has approved the R21 malaria vaccine for the immunization of children aged 5 months to 36 months against Malaria caused by Plasmodium Falciparum.

The vaccine is a solution for injection that is stored in a refrigerator between 2 and 8°C and has a shelf life of 24 months.

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The approval was granted to the vaccine manufacturer, the Serum Institute of India, through the local agent, DEK Pharmaceuticals Ghana, after extensive reviews of the clinical, non-clinical, and quality aspects of the vaccine development process.

The CEO of the FDA, Dr. Delese Darko, stated that the vaccine has the potential to reduce infant mortality caused by malaria in Africa.

Ghana was chosen for the approval process due to the FDA’s expertise in evaluating the quality of medicines and vaccines.

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