By Kunle Obafemi
The National Agency for Food and Drug Administration and Control, NAFDAC, on Monday approved R21 malaria vaccine for the prevention of malaria.. The approval of the vaccine manufactured by the Serum Institute of India, makes Nigeria the second country to approve the vaccine after Ghana.
The Director General of NAFDAC, Prof. Mojisola Adeyeye made the approval known to the public during a media briefing. She explained that the R21 malaria vaccine has 75 per cent efficacy in protecting against malaria, noting that the vaccine’s benefits outweigh its envisaged risks.
“The vaccine is effective for the prevention of malaria in children from five months to 36 months of age and the vaccine is stored in a temperature of 2-8°C,” said Adeyeye.
Adeyeye added that Nigeria would get about 100,000 doses of the vaccine as donations before its authorisation for sale in the market and other arrangements with the National Primary Health Care Development Agency (NPHCDA).
“The Marketing Authorization has been given to Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021. The approval of the R21 Malaria Vaccine was recommended and done according to the the World Health Organization’s (WHO’s) Malaria Vaccine Implementation Guideline,” said Adeyeye.
Speaking further, the NAFDAC helmswoman emphasised that malaria was one of the most vital diseases giving concern to public health globally. She added that the latest World Health Organization World Malaria Report revealed that there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020. The recorded number of malaria deaths was 619, 000 in 2021 in contrast with 625, 000 in 2020.
Likewise, Adeyeye explained that the approval of the R21 Malaria vaccine has been forwarded to the Minister of Health and National Primary Health Care Development Agency for appropriate actions and possible immunization of children within the stipulated age bracket.
She pledged that NAFDAC would only allow products that are safe, high quality and effective, available to Nigerians.