The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the provisional use of the R21 malaria vaccine in the country.
The NAFDAC Director-General, Prof. Mojisola Adeyeye, made this known at a press briefing in Abuja on Monday, April 17.
Adeyeye stated that the R21 Malaria vaccine complies substantially with the best international standards, which made the joint review committee conclude that the data on the vaccine was robust and met the criteria for efficacy, safety, and quality.
She said the review committee declared that the vaccine is 75 perc ent effective in protecting against malaria, adding that the vaccine would prevent clinical malaria in children from 5 months to 36 months of age.
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NAFDAC boss, who said the provisional approval of the vaccine will make Nigeria the second country in the world to approve its use after Ghana, disclosed that the nation (Nigeria) will receive about 100,000 doses of the vaccine in donations soon.
Adeyeye said the donations would commence before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency (NPHCDA).
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. (SIIPL).
“The Marketing Authorisation 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 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.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the World Health Organization’s (WHO) Malaria Vaccine Implementation Guideline,” the NAFDAC DG stated.
