The National Agency for Food and Drug Administration and Control (NAFDAC) has granted regulatory approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) produced by the Serum Institute of India Pvt. Ltd. (SIIPL).
NAFDAC Director General, Prof. Mojisola Adeyeye, made the announcement during a press conference in Abuja.
Adeyeye said the vaccine is an adjuvanted protein vaccine presented as a sterile solution for prevention of clinical malaria in children from 5 to 36 months of age. The R21 Malaria Vaccine was reviewed in line with the WHO's Malaria Vaccine Implementation Guideline.
Adeyeye added that the Agency has communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria.
Malaria is one of the most important public health concerns in the world, with Nigeria being one of the most affected countries.
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