Nigeria: The National Agency for Food and Drug Administration and Control (NAFDAC), the Nigerian apex regulatory body for food and drugs has approved the R21 Malaria Vaccine for use in the country.
This development makes Nigeria the second country on the continent, behind Ghana to approve the new malaria vaccine produced by scientists at the University of Oxford.
The vaccine is targeted at preventing clinical malaria in children from the age range of five months to 36 months.
Professor Mojisola Adeyeye, Director-General of NAFDAC, told journalists in Abuja on Monday that the agency received the dose of the R21 Malaria vaccine, manufactured by the Serum Institute of India Pvt Ltd (SSPL) and reexamined it at two levels.
She said: “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 Marketing Authorization Holders (MAHs) is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.”
Adeyeye said NAFDAC had several pathways for the registration of vaccines in line with its 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, she added.
She said overall, the R21 Malaria vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked.
She said the Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met the criteria for efficacy, safety, and quality.
“It was also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use,” she said.
