The Director General of the National Agency For Food and Drug Administration and Control, NAFDAC, Professor Mojisola Adeyeye, said yesterday that the approval process for the R21/Matrix-M malaria vaccine requires more clinical trials before its full use.
Recall that NAFDAC made public development of the vaccine about two weeks ago.
Prof. Adeyeye, who disclosed this in an interview on Channels Television's breakfast programme, Sunrise Daily, Adeyeye noted that development in a country's governance was a contributing factor to the persistence of malaria in Africa.
She said provision of the vaccine was important for transmission prevention, insisting that NAFDAC would conduct its own test, trials and levels of approval.
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.
"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 per cent effectiveness for a malaria vaccine, which is great."
Adeyeye said phase four clinical trials would be conducted, adding that more laboratory work would also be done.
"However, it is not what is written only that we know as the efficacy; we have to check every line of the dossier to ensure that science speaks. This is science-driven. What we did was to have two sets of review," she said.
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According to her, NAFDAC will for the first time in its history, have an external expert body for phase four.
She added: "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 stated said the vaccination focus was mainly on children and not adults, stressing this was the limitation the RTS,S malaria vaccine had in its percentage efficacy.
"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. "
