National Agency for Food and Drug Administration and Control has said that it would be carrying out post-marketing surveillance on the approved Oxford/AstraZeneca’s COVID-19 vaccine in Nigeria.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, disclosed this on Friday, saying that the agency would monitor individuals who receive the vaccine for side effects and any adverse reaction.
NAFDAC had, on Thursday, approved AstraZeneca COVID-19 vaccine for the management of the pandemic in Nigeria.
The World Health Organisation had recently approved it for emergency use.
Speaking during a live interview on TVC, Adeyeye said: “Most of the clinical trials that have been held on these vaccines were done using Caucasian populations.
“And because of genetic differences, even the same siblings of the same parents have differences in the way they handle medicines.
“So, I said we cannot get a vaccine into Nigeria without a dossier. We cannot have a COVID-19 vaccine, without NAFDAC looking at the dossier. That is why we are using active pharmacovigilance for any vaccine that is going to be approved by NAFDAC.
“Active pharmacovigilance is when somebody gets a shot of the vaccination, we start monitoring that individual for about a year, just to be sure that there are no side effects or adverse reactions.
“We have to monitor the individuals. We are going to be using Med Safety Mobile App, which was launched last year by the minister of health.
“It is an app that anybody can download, but it is meant for health workers. So that when a person gets this vaccine, there is a means to record what is happening.
“The individual can enter observed side effects into the app and we will collate the reports at NAFDAC.”
“But more importantly, we are trying also to make sure that we study the differences because this is going to be used by different countries in Africa, including Nigeria
“We are going to check the differences, even among populations, and then check the differences between us and other countries. So, we are putting safeguards in place.”
“NAFDAC will be carrying out the monitoring in collaboration with the National Primary Healthcare Development Agency and the Nigeria Centre for Disease Control.”
She also said that NPHCDA would be vaccinating millions of Nigerians, while NAFDAC would be observing pharmacovigilance.
She disclosed that there will be 12 sentinel sites in the country, two in each of the six geopolitical zones.