Following Ghana’s example from the previous week, Nigeria’s pharmaceuticals regulator said on Monday that the R21 malaria vaccine produced by Oxford University had been granted preliminary approval.
Because the vaccine’s final-stage research data has not yet been made public, this is a one-of-a-kind set of approvals.
“A provisional approval of the R21 Malaria Vaccine was recommended, and this shall be done in accordance with the WHO’s Malaria Vaccine Implementation Guideline,” Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) noted.
Malaria, a mosquito-borne illness, kills over 600,000 people in Africa each year, the majority of whom are children.
According to WHO research published in 2021, Nigeria, the continent’s most populated country, accounts for 27% of global illnesses and 32% of global deaths.
The World Health Organization and other regulatory agencies are now evaluating the R21 vaccine for safety and effectiveness, therefore it is unclear when it will be available in Nigeria or Ghana.
Following WHO approval, international organizations such as Gavi, the vaccine alliance, often give some money for children’s vaccinations in Africa’s poorest areas.
“While granting the approval, the Agency also communicated the need for an expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria,” said Mojisola Christianah Adeyeye, director-general of NAFDAC.
In September, researchers published preliminary findings from the R21 trial, which involved over 400 young children, indicating that the immunization was 70 to 80 percent effective 12 months after the fourth dose.
In the next months, we anticipate seeing the findings of the phase 3 clinical trial including 4,800 children from Burkina Faso, Kenya, Mali, and Tanzania.
The Serum Institute of India collaborates with Oxford to produce up to 200 million doses of R21 every year. Mosquirix, produced by GSK, was authorized by the World Health Organization last year, but GSK is struggling to satisfy demand owing to a funding constraint.
