NAFDAC gives approval for R21 malaria vaccine

By Tobias Lengnan Dapam

The National Agency for Food and Drug Administration and Control (NAFDAC), had given a provisional approval for R21 malaria vaccine for use in Nigeria.

The Director General of the Agency, Prof Mojisola Adeyeye stated this on Monday during a press briefing in Abuja.

She said the approval of the vaccine manufactured by the Serum Institute of India, indicated that Nigeria becomes second country to approve the product after Ghana.

She explained that the review committee recognised that the vaccine is 75 percent effective in protecting against malaria.

She added that the vaccine’s potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.

The NAFDAC boss further explained that the provisional approval of the R21 makes Nigeria the second country in the world to approve its use after Ghana, adding that 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 (NPHCDA), NAFDAC.

She said the vaccine is indicated for prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C.

“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. (SIIPL).

“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.

“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the the World Health Organization’s (WHO’s) Malaria Vaccine Implementation Guideline.”

She said Malaria is one of the most important public health concerns in the world, adding that the latest WHO World

Malaria Report showed that there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020.

“The estimated number of malaria deaths stood at 619 000 in 2021 compared to 625 000 in 2020.”

Speaking further, she explained that the brief on the approval of the R21 Malaria vaccine has been communicated to the Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunization in the respective population.