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.
According to the Punch NG, a Nigerian newspaper, this information was provided on Monday during a news conference in Abuja by Prof. Mojisola Adeyeye, Director General of Nigeria’s drug regulatory body, 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.
“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,” Prof. Adeyeye stated.
The R21 malaria vaccine dossier, in the professor's opinion, significantly conformed with the highest international standards against which the dossier was bench-marked. Prof. Adeyeye 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.
“The Joint Review Committee also recommended an additional phase four clinical trial, pharmacovigilance study in-country in the implementation given the peculiarity and heterogeneous nature of malaria in Nigeria. The Joint Review Committee was also interested in reviewing data of the human-malaria parasite dynamics of the 25% not covered to understand issues bothering on non-protection that could inform further research.
A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHO’s Malaria Vaccine Implementation Guideline,” she noted.