Nigeria has granted provisional approval to Oxford University’s R21 malaria vaccine, its medicines regulator said 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.
“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,” Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) said.
Malaria, a mosquito-borne disease, kills more than 600,000 people each year, most of them African babies and children.
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 (WHO) report.
It was unclear when the R21 vaccine may be rolled out in Nigeria or Ghana as other regulatory bodies, including the WHO, are still assessing its safety and effectiveness.
Childhood vaccines in the poorest parts of Africa are typically co-funded by international organizations such as Gavi, the vaccine alliance, only after getting WHO approval.
“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.
Mid-stage data from the R21 trial involving more than 400 young children were published in September, showing vaccine efficacy of 70% to 80% at 12 months following the fourth dose.
Source : VOA
