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.
“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 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 organisations 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 between 70-80% at 12 months after the fourth dose.
Data from an ongoing phase 3 clinical trial involving 4,800 children in Burkina Faso, Kenya, Mali and Tanzania are due to be published in the coming months.
Oxford has a deal with the Serum Institute of India to produce up to 200 million doses of R21 annually.
The first malaria vaccine, Mosquirix from British drugmaker GSK, was endorsed by the WHO last year, but a lack of funding is thwarting GSK's capacity to produce enough doses.
Reuters
Nigeria regulator grants approval to Oxford's malaria vaccine
Image: REUTERS/Baz Ratner/File Photo
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.
“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 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 organisations 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 between 70-80% at 12 months after the fourth dose.
Data from an ongoing phase 3 clinical trial involving 4,800 children in Burkina Faso, Kenya, Mali and Tanzania are due to be published in the coming months.
Oxford has a deal with the Serum Institute of India to produce up to 200 million doses of R21 annually.
The first malaria vaccine, Mosquirix from British drugmaker GSK, was endorsed by the WHO last year, but a lack of funding is thwarting GSK's capacity to produce enough doses.
Reuters
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