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FG Grants Provisional Approval For Oxford R21 Malaria Vaccine
The federal government of Nigeria has granted provisional approval for the R21/Matrix malaria vaccine developed by the Oxford University.
Director-general of the National Agency for Food and Drug Administration And Control (NAFDAC), Prof. Mojisola Adeyeye, disclosed this at a press briefing on Monday in Abuja.
This came days after Ghana became the first country to approve the vaccine, which is manufactured by the Serum Institute of India Pvt Ltd.
Adeyeye said the vaccine was indicated for prevention of clinical malaria in children from five months to three years of age, adding that the storage temperature of the vaccine is 2-8 °C.
“The R21 Malaria vaccine is an Adjuvanted protein vaccine presented as a sterile solution. A dose which is 0.5ml is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an adjuvant filled in a vial as ready to use liquid formulation for intramuscular injection.
“The vaccine is indicated for prevention of clinical malaria in children from five months to 36 months of age. The storage temperature of the vaccine is 2-8 °C,” she said.
She noted that the Agency’s pathway for registration of vaccines were in line with its guideline for registration of Imported Drugs, Vaccines and IVDs under Collaborative Registration Procedure.
“The R21 Malaria Vaccine was reviewed using the later which involves full review of product dossiers,” the NAFDAC DG explained.
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