Few days after Ghana gave its nod, the Nigerian government has approved the use of R21 Malaria Vaccine (Recombinant, Adjuvanted).
This was disclosed by the National Agency for Food and Drug Administration and Control (NAFDAC) in a press briefing on Monday April 17, 2023.
The vaccine is manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
During the briefing, the Director General of NAFDAC, Mojisola Adeyeye, said the approval is made by the Agency in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004.
Adeyeye explained that 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 a ready-to-use liquid formulation for intramuscular injection.
“The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C,” she said.
Adeyeye also said NAFDAC has several pathways for the registration of vaccines, and are in line with the Agency’s guideline for registration of imported drugs, vaccines and IVDs under collaborative registration procedure.
