NAFDAC must approve COVID-19 vaccine before public use, says DG

Mojisola Adeyeye, director-general of the National Agency for Food and Drug Administration and Control, has warned Nigerians not to take any COVID-19 vaccine except the ones approved by the agency.

The federal government had said it was expecting the delivery of 20 million doses of COVID-19 vaccines to the country early 2021.

Speaking at a media briefing on Friday, Adeyeye said the agency has not approved any vaccine and that it is yet to receive any application from COVID-19 vaccine manufacturers.

She said no vaccine or commodity can be used in the country without the approval of NAFDAC.

She said the World Health Organisation is not a regulatory agency but provides guidance to agencies; hence, regulatory agencies need to certify potential vaccines for public use.

She said the right step is for government agencies to confirm if the said vaccine has been approved by NAFDAC before going ahead to procure.

“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.”

Adeyeye said NAFDAC is in discussion 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.

“NAFDAC will welcome the application for emergency use authorisation in Nigeria.

The Nigerian Medical Association (NMA) earlier said COVID-19 vaccines need to undergo clinical trial before being administered on Nigerians.