Mojisola Adeyeye, the Director-General, National Agency for Food and Drug Administration and Control (NAFDAC) says the agency has not approved any COVID-19 vaccines in Nigeria
She disclosed this in a statement made public on Friday in Abuja.
She said that the agency had not received any application from vaccine manufacturers “and therefore, no vaccine had been approved by NAFDAC. The federal government had said it was expecting the delivery of 20 million doses of COVID-19 vaccines to the country early 2021.
She mentioned that the World Health Organisation is not a regulatory agency but provides guidance to agencies; therefore, regulatory agencies need to certify potential vaccines for public used.
“The WHO will say that unless the regulatory agency of a country approves a vaccine, it should not be used. WHO is not a regulatory agency that will approve and say use, they are there to guide and give regulatory agencies more confidence,” she said.
“If a product is already on WHO emergency use listing, the regulatory agency will still look at the application. That doesn’t mean we just pass it like that, we will have to read it within the context of our environment. No vaccine or commodity can be used unless it passes through NAFDAC in Nigeria.
“Vaccines should not be ordered by any company or corporation. The companies that manufacture the vaccines if they are genuine companies know they have to submit their application to NAFDAC.
“No government establishment or agencies should order COVID-19 vaccines without confirming from NAFDAC if the vaccine has been approved.
“COVID-19 vaccines are new, and the side effects or adverse events must be well monitored, therefore, if NAFDAC does not approve, the public should not use.”
The Director General said NAFDAC is already discussing with manufacturers of COVID-19 vaccines concerning potential emergency use authorisation, registration or licensing of their product.
”The agency assures applicants that if phase three clinical data are very convincing and robust with regards to safety and efficacy and the vaccine has been submitted for WHO for Emergency Use Listing,” she said.
Mojisola Adeyeye, the Director-General, National Agency for Food and Drug Administration and Control (NAFDAC) says the agency has not approved any COVID-19 vaccines in Nigeria
She disclosed this in a statement made public on Friday in Abuja.
She said that the agency had not received any application from vaccine manufacturers “and therefore, no vaccine had been approved by NAFDAC. The federal government had said it was expecting the delivery of 20 million doses of COVID-19 vaccines to the country early 2021.
She mentioned that the World Health Organisation is not a regulatory agency but provides guidance to agencies; therefore, regulatory agencies need to certify potential vaccines for public used.
“The WHO will say that unless the regulatory agency of a country approves a vaccine, it should not be used. WHO is not a regulatory agency that will approve and say use, they are there to guide and give regulatory agencies more confidence,” she said.
“If a product is already on WHO emergency use listing, the regulatory agency will still look at the application. That doesn’t mean we just pass it like that, we will have to read it within the context of our environment. No vaccine or commodity can be used unless it passes through NAFDAC in Nigeria.
“Vaccines should not be ordered by any company or corporation. The companies that manufacture the vaccines if they are genuine companies know they have to submit their application to NAFDAC.
“No government establishment or agencies should order COVID-19 vaccines without confirming from NAFDAC if the vaccine has been approved.
“COVID-19 vaccines are new, and the side effects or adverse events must be well monitored, therefore, if NAFDAC does not approve, the public should not use.”
The Director General said NAFDAC is already discussing with manufacturers of COVID-19 vaccines concerning potential emergency use authorisation, registration or licensing of their product.
”The agency assures applicants that if phase three clinical data are very convincing and robust with regards to safety and efficacy and the vaccine has been submitted for WHO for Emergency Use Listing,” she said.
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