LAGOS - Nigeria's food and drug regulator has granted provisional approval to Oxford University's R21 malaria vaccine, it said on Monday, following a similar announcement by Ghana last week.
The approval is unusual as it comes before the publication of final-stage trial data for the vaccine, which aims to curb the mosquito-borne disease that kills more than 600,000 people each year, most of them African babies and children.
"A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHO's Malaria Vaccine Implementation Guideline," said Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC).
"While granting the approval, the Agency has also 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," it said in a statement by its director-general, Mojisola Christianah Adeyeye.
(Reporting by MacDonald Dzirutwe; Writing by Estelle Shirbon; Editing by Alexander Winning)