Malaria Vaccine Clinical Trials Will Begin In Six Weeks – NAFDAC
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 RTSS 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.