"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.
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.
Oxford has a deal with Serum Institute of India to produce up to 200 million doses of the vaccine - known as R21 - annually.
This is the first time a major vaccine has been approved in an African country ahead of rich nations, Hill said. Approving a vaccine before the publication of data from final-stage trials is also rare, experts told Reuters.
