Nigeria has granted provisional approval to Oxford University's R21 malaria vaccine, its medicines regulator said on Monday, making it the second country to do so after Ghana last week.
The approvals are unusual as they have come before the publication of final-stage trial data for the vaccine.
Nigeria, the continent's most populous nation, is the world's worst-affected country with 27% of global cases and 32% of global deaths, according to a 2021 World Health Organization report. “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,” Nafdac's director-general, Mojisola Christianah Adeyeye, said in a statement.
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