The Director General of the National Agency For Food and Drug Administration and Control (NAFDAC), Professor Mojisola Adeyeye, has said the approval process for the R21/Matrix-M malaria vaccine requires more clinical trials before its full use.
Speaking on Channels Television Sunrise Daily on Wednesday, Adeyeye noted that development in a country’s governance is a contributing factor to the persistence of malaria in Africa.
She stated that the provision of the vaccine is important for transmission prevention, adding that NAFDAC is going to do its own test, trials and levels of approval.
“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 percent, so we did not agree to join the clinical trial,” the NAFDAC boss said.
“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 percent 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.”
Adeyeye noted that phase four clinical trials would be conducted and more laboratory work.
“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.
According to her, for the first time in the agency’s history, NAFDAC is going to have an external expert body for phase four.
“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.
The NAFDAC boss stated that the vaccination focus is mainly on children and not adults, adding that this was the limitation the RTS,S malaria vaccine had in its percentage efficacy.
“Even if it is only 30 percent 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,” she said.
“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”
Adeyeye stated that the NAFDAC as a regulatory body is doing all in its power to think critically and judiciously evaluate the dossier and come to a decision.
“The 75 percent, I believe, is a great point or great efficacy to start with in terms of our own people. But the clinical trial will start very soon.
“I have been talking with the manufacturer, with the market authorisation holder in Nigeria. The clinical trial will begin very soon. The experts have suggested younger colleagues in the universities that will be part and parcel of the clinical trial,” she said.