The National Agency for Food and Drug Administration and Control, NAFDAC, on Monday, gave provisional approval for R21 malaria vaccine for use in Nigeria.
With the approval of the vaccine produced by the Serum Institute of India, Nigeria joins Ghana as the second nation to do so.
In addition, while the review committee acknowledged that the vaccine is 75% effective at preventing malaria, Prof. Christianah Adeleye, Director General of the Agency during a media briefing, added that the vaccine’s potential benefits outweigh its known and potential risks, supporting the manufacturer’s recommended use.
Adeleye added that Nigeria expects to receive at least 100,000 doses of the vaccine in donations soon before the market authorization will start making other arrangements with the National Primary Health Care Development Agency (NPHCDA), NAFDAC. With the provisional approval of the R21, Adeleye said that Nigeria is now the second country in the world to approve its use after Ghana.
According to her, the vaccine is recommended for use in children between the ages of 5 and 36 months to prevent the development of clinical malaria.The vaccination should be stored between 2 and 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.”
Stating that Malaria is one of the most important public health concerns in the world., she noted 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.
Continuing, 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.
She further pledged NAFDAC is committed to ensuring that only products that are safe, high quality, and efficacy are made available for Nigerians.