Nigeria has granted provisional approval for the R21 Malaria Vaccine, its first ever malaria vaccine, which is said to be 75% effective in preventing malaria in children aged five to 36 months.
The vaccine is manufactured by Serum Institute of India Pvt Ltd, with Fidson Healthcare PLC as the Marketing Authorisation Holder in Nigeria.
In contrast, Ghana approved its second malaria vaccine last week.
Ghana’s vaccine, the R21/Matrix-M, was developed by the University of Oxford in the UK and manufactured by the Serum Institute of India.
Malaria is a significant health problem in Nigeria, and the country has the highest number of global malaria cases and deaths in the world.
The National Agency for Food and Drug Administration and Control (NAFDAC) has communicated the need for expansion of the clinical trial conducted to include a Phase Four clinical trial/Pharmacovigilance study to be carried out in Nigeria.