Abuja, April 17, 2023 – NAFDAC has granted registration approval to R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).
Prof. Mojisola Adeyeye, the NAFDAC Director General, announced this at a press briefing on Monday.
She said the approval was made by the Agency in the exercise of its mandate as stipulated in its enabling law, NAFDAC Act CapN1, LFN 2004.
She said that that Fidson Healthcare Ltd would be the Marketing Authorisation Holder (MAHs) for the vaccine in line with NAFDAC’s Drug and Related Products Registration Regulation 2021.
Adeyeye explained that the R21 Malaria vaccine is an Adjuvanted protein vaccine being 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,” Adeyeye said.
