Professor Mojisola Adeyeye, the Director General of the National Agency For Food and Drug Administration and Control (NAFDAC) has said the R21/Matrix-M malaria vaccine clinical trials will soon begin in Nigeria.
According to the Minister of Health, Dr Osagie Ehanire, in spite of efforts by relevant stakeholders to combat effects of malaria in Nigeria, the country still accounts for 27 per cent of global malaria cases and 32 per cent of global malaria deaths.
About 55 million cases of malaria and 90,000 malaria-related deaths occur annually in country.
Commenting on the issue on Channels TV’s Sunrise Daily, the NAFDAC boss said, “The clinical trial will begin within the next six weeks. The RTS,S did not include Nigeria, because from the beginning the effectiveness was 30 per cent, so we did not agree to join the clinical trial.
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“For the R21, after reading the dossier, I believe Nigeria should join. This is because we have a high probability of success. If something is 75 per cent effective from the beginning, then we know they are very likely to be successful. It has 75 percent effectiveness for a malaria vaccine, which is great,” she added.
Adeyeye noted that this is the first time in history NAFDAC is going to have an external expert body for phase four clinical trials.
“We are going to do phase four clinical trials; it should be tested in our country. We are going to do more observation. This would involve more laboratory works, this cannot be administered until it goes through a testing process in the country before the transmission process,” Adeyeye said.
According to her, the vaccination focuses on children not adults.
“Even if it is only 30 per cent of the children that will not die or the death would be prevented, that will be good enough. But we didn’t take that up as an agency to be part of the trial. This particular R21 had been submitted to WHO and they are going to be doing their own review.
“NAFDAC approved the R21 vaccine for children under five, specifically for those under three years. NAFDAC tested the second vaccine (RTSS) and was not found effective enough. Nigeria is part of this one, that is R21, we gave provisional approval after a very rigorous approval process,” she added.
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