The National Agency for Food and Drug Administration and Control (NAFDAC) has granted registration approval for the R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India.
Director General of NAFDAC, Mojisola Adeyeye, in a press briefing explained that the R21 Malaria vaccine is an Adjuvanted protein vaccine presented as a sterile solution.
According to her, The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.
Adeyeye said NAFDAC has several pathways for the registration of vaccines and these pathways are in line with the Agency’s guideline for registration of imported drugs, vaccines and IVD’s under collaborative registration procedure.