FG Grants Regulatory Approval for R21 Malaria Vaccine, Awaits Donation

April 17, 2023

The Federal Government has granted the regulatory approval for R21/Matrix vaccine developed by the Serum Institute of India.

The Director-General of the National Agency for Food and Drug Administration And Control (NAFDAC), Mojisola Adeyeye, announced this during a press briefing on Monday.

“One of the things that the Serum Institute of India contact said is that Nigeria will get a donation first as quickly as possible. Our expectation is that the vaccine will come in very soon, at least hundreds of thousands of doses as donations first before the market authorization will start making other arrangements with the National Primary Healthcare Development Agency (NPHCDA)”.

Adeyeye noted that a full review using the standards of the World Health Organisation was carried out on the vaccine to ensure its efficacy, safety, and quality.

The NAFDAC boss said the provisional approval for the vaccine is in line with the World Health Organisation (WHO)’s Malaria vaccine implementation guideline, making Nigeria the second country to approve the vaccine after Ghana.

“The vaccine will address the prevention of malaria in children from 5 to 36 months of age where Nigeria has the highest prevalence of malaria in the world with over 27 per cent, and the highest number of global malaria deaths of 32 per cent”.

“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.