The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the provisional use of R21 malaria vaccine manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
Which makes Nigeria the second country in the world after Ghana to approve the use of R21 malaria vaccine.
Prof Mojisola Adeyeye, the Director General of NAFDAC announced this during a press conference on Monday in Abuja.
Adeyeye said that the approval of the vaccine was inline with the agency’s enabling law, NAFDAC Act CapN1, LFN 2004, adding that the marketing authorization holder is Fidson Healthcare Ltd in line with the 2021 agency’s drug registration regulation.
She said, “NAFDAC in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd.”
“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.
“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.”
Adeyeye also said that the vaccine was for the prevention of clinical malaria in children from 5 to 36 months of age, with a storage temperature of 2-8°C.
She continued that the dossier of the vaccine was subjected to independent review at two levels using best review practices and was scored satisfactory by the committee.
