Nigeria becomes second country to approve R21 malaria vaccine

By Olivia Nnorom

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the R21 malaria vaccine manufactured by the Serum Institute of India., which  makes Nigeria the second country after Ghana  to approve the new malaria vaccine developed at the University of Oxford.

Mojisola Adeyeye, the director general of NAFDAC, disclosed this on Monday at a press briefing in Abuja, where she said the vaccine is indicated for the prevention of clinical malaria in children from five months to 36 months of age.

“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.”  Adeyeye said.

According to Adeyeye, Nigeria expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency.

Speaking on the vaccine qualitative and quantitative makeup, the NAFDAC DG said that the R21 Malaria vaccine with storage temperature of 2-8 °C, 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.

She also noted that the dossier of the vaccine was subjected to independent review at two levels;  review by NAFDAC’s vaccine advisory committee independently using standards of the World Health Organisation across relevant domains; review by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use guidelines, European Medicines Agency guidelines, scientific rigour on the vaccine and the context of malaria and specifically to Nigeria and best research and manufacturing governance.

“NEVAC members reviewed all sections independently using best review practices and met physically in plenary to assess and debate the reviews by sections, raised queries, and made recommendations accordingly.” Adeyeye said.

Speaking on NAFDAC’s review, she said the Committee has always been guided by the same international standards and best practices with the same modality of an independent review by members followed by long hours of plenary where a rigorous assessment of each review took place. Also, the Committee independently scored the assessment as satisfactory and forwarded it to the Director General.

Adeyeye confirmed that the R21 malaria vaccine dossier compiled substantially with the best international standards with which the dossier was benched-marked, and noted that the Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met the criteria for efficacy, safety, and quality.

Also, the joint review committee confirmed that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.