The R21 malaria vaccine manufactured by the Serum Institute of India has been approved by the National Agency for Food and Drug Administration and Control.
Prof Mojisola Adeyeye, Director General of NAFDAC, made the announcement on Monday at a news conference in Abuja.
Nigeria is now the second country after Ghana to accept the novel malaria vaccine developed at the University of Oxford.
According to Prof. Adeyeye, children between the ages of 5 and 36 months are eligible for the vaccination to prevent clinical malaria.
She noted that before the market authorization, the country expects to receive at least 100,000 doses of the vaccine in contributions soon.
“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.
“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.”
The professor said that the R21 malaria vaccine dossier largely complied with the highest international requirements that it was compared to, adding that the Joint Review Committee decided that the data for the R21 malaria vaccine were trustworthy and met the requirements for quality, efficacy, and safety.
Furthermore, it was concluded that the vaccine’s known and potential benefits outweigh its known and possible drawbacks, justifying the manufacturer’s recommended use.
Source News: Punch Nigeria
