Following a similar announcement by Ghana last week, Nigeria’s food and drug agency said on Monday that Oxford University’s R21 malaria vaccine had received preliminary approval.
“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 unique since it occurs before the vaccine’s final-stage trial results are published. The vaccine is intended to stop the mosquito-borne disease that kills more than 600,000 people annually, the majority of whom are newborns and young children from Africa.
Oxford and Serum Institute of India have a contract to produce up to 200 million doses of the R21 vaccine per year.
According to Hill, this is the first time a significant vaccination has been licensed in an African nation before wealthy ones. It is also uncommon for a vaccine to be approved before final-stage study data have been published, according to specialists.