The National Agency for Food and Drug Administration Control, NAFDAC, has approved the serum Institute of India Limited’s R21 Malaria Vaccine (Recombinant, Adjuvanted) in accordance with the agency’s mandate under the NAFDAC Act CapN1, LFN 2004.
NAFDAC Director General Prof. Mojisola Adeyeye, who revealed the approval during a news conference on Monday in Abuja said Malaria is a critical global public health issue.
Adeyeye noted that the R-21 Malaria vaccine dossier complies substantially with the best international standards, which made the Joint Review Committee conclude that the data on the R-21 Malaria vaccines were robust and met criteria for efficacy, safety, and quality.
She stated that while the review committee recognized that the vaccine is 75 percent effective in protecting against malaria, it also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
The Director General further explained that the vaccine is indicated for prevention of clinically malaria on Children from the age of 5months to 36months, adding that the vaccine mist be stored at he temperature of 2⁰C to 8⁰C.
NAFDAC said the provisional approval of the R-21 malaria vaccine makes Nigeria the second country in the world to approve its use after Ghana.