The National Agency for Food and Drug Administration and Control says it will 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 [today], saying the agency will 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.
Giving insight into the approval on a live TV interview, the NAFDAC DG said, “Most of the clinical trials that have been held on these vaccines were done using Caucasian population.
“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 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.”
Adeyeye noted, “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.”
Adeyeye said NAFDAC will be carrying out the monitoring in collaboration with the National Primary Healthcare Development Agency and the Nigeria Centre for Disease Control.
She said NPHCDA will be vaccinating millions of Nigerians, while NAFDAC will be observing the pharmacovigilance.
She revealed that there will be 12 sentinel sites in the country, two in each of the six geopolitical zones.
According to her, it is at that sentinel sites that more rigorous observation will be done.
The NAFDAC boss said the agency got the vaccine’s dossier a week ago, and that its safety committee went to work immediately to evaluate its safety and efficacy for Nigerians.
“So, NAFDAC is not approving dossier for emergency use just like that. It doesn’t matter how great the results are in phases one and two. In phase three that involves thousands, we need the data.
“NAFDAC will not approve anything that is going to hurt our people. So, phase four or post-marketing surveillance is in place to monitor the effect on the population. There is no drug or vaccine that have been manufactured without side effects”, she explained.
Nigeria wants to vaccinate as much as 50 per cent of its population against the coronavirus in 2021, but is yet to land its first batch of vaccines despite several arrangements and partnerships the country had keyed into to secure the much needed jabs.
Nigeria is expected to receive an initial 16 million doses of the AstraZeneca COVID-19 vaccines through the Vaccines Global Assess Facility by the end of February.
The country is also expecting an additional 42 million doses of the approved COVID-19 vaccines.
