R21 malaria vaccine gets NAFDAC approval

By Deborah Onyofufeke
National Agency for Food and Drug Administration and Control (NAFDAC)

NAFDAC Director General, Professor Mojisola Adeyeye, Stated that the vaccine is an Adjuvanted protein vaccine presented as a sterile solution.

She added that the vaccine is for the prevention of clinical malaria in children between 5 months to 3 years.

Professor Adeyeye made this disclosure at a media briefing in Abuja on Monday.

She explained that the approval by the Agency is part of exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004.

She further disclosed that the Marketing Authorization Holders (MAHs) is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.

Speaking on the vaccine she said “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, also said for the dossier review, NAFDAC received the dossier of the R21 Malaria manufactured by the Serum Institute of India Pvt Ltd (SSPL) and was subjected to independent review at two levels.

“As a matured regulatory agency, it is expected as part of global benchmarking that an external advisory committee is in place to advise upon invitation on certain functions of the Agency.
“As a new biological molecule that is being given consideration for full registration, the independent review by an external body becomes imperative as a means to further safeguard public health.”

The NAFDAC boss added that the agency has several pathways for the registration of vaccines which are in line with the Agency’s guideline for registration of imported drugs, vaccines and IVDs under collaborative registration procedure, or the Agency’s guideline for registration of imported drugs and vaccines.
“The R21 Malaria vaccine was reviewed using the latter which involves a full review of product dossiers.”