Professor Mojisola Adeyeye, Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), has stated that the clearance procedure for the R21/Matrix-M malaria vaccine needed more clinical trials before its full use.
Adeyeye stated on a Wednesday program that improvement in a country’s governance is a role in the persistence of malaria in Africa.
She noted that the availability of the vaccine is critical for transmission prevention, and that NAFDAC will conduct its own tests, 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 stated that phase four clinical studies and additional laboratory work would be carried out.
“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.
“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 claimed that the vaccination focus is mostly on children, not adults, and that this was the limitation of the RTS,S malaria vaccine’s 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.
“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.
