The R21 malaria vaccine produced by the Serum Institute of India has received approval from the National Agency for Food and Drug Administration and Control.
This information was provided on Monday during a news conference in Abuja by Prof. Mojisola Adeyeye, Director General of NAFDAC.
Nigeria now joins Ghana as the second nation to accept the novel malaria vaccine created by the University of Oxford.
According to Prof. Adeyeye, the vaccine is recommended for use in children between the ages of 5 and 36 months to prevent the development of clinical malaria.
She stated that before the market authorization will begin making further arrangements with the National Primary Health Care Development Agency, the nation anticipates receiving at least 100,000 doses of the vaccine in contributions shortly.
Adeyeye stated that NAFDAC is providing registration permission for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd. as part of its mandate as outlined by NAFDAC Act CapN1, LFN 2004.
According to the Agency’s Drug and Related Products Registration Regulation 2021, Fidson Healthcare Ltd. is the holder of the marketing authorization.
The R21 Malaria vaccine is a protein vaccine with adjuvants that is administered as a sterile solution. R21 Malaria Antigen 5g and Matrix-M1 50g as an adjuvant are combined in a 0.5ml dose to provide a ready-to-use liquid formulation for intramuscular injection.
The vaccine is recommended for use in children between the ages of 5 and 36 months for the prevention of clinical malaria. The vaccination should be stored between 2 and 8 °C.
She claimed that the vaccine’s dossier underwent two levels of independent assessment.
She claimed that the R21 malaria vaccine dossier substantially conformed with the highest international criteria against which it was bench-marked.
She claimed that the Joint Review Committee found the R21 malaria vaccine data to be reliable and to meet the standards for efficacy, safety, and quality.
Additionally, it was determined that the vaccine’s known and potential advantages outweigh its known and possible drawbacks, justifying the manufacturer’s advised use.
