The National Agency for Food and Drug Administration and Control (NAFDAC) is pleading with Nigerians to beware of fake vaccines reported to be in circulation as no COVID vaccines have been approved by the agency.
The Director-General of the Agency, Prof Mojisola Christianah Adeyeye who disclosed this on Friday revealed that those fake vaccines can cause COVID-like illnesses or other serious diseases that could kill, adding that the agency has not received any application from COVID vaccine manufacturers yet.
The Director-General added that COVID-19 vaccines are new, and the side effects or adverse events must be well monitored and therefore, if NAFDAC does not approve, the public should not use them.
Adeyeye who also noted the unapproved ordering of COVID vaccines by private companies and cooperation said: “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.”
She emphasized that no government establishment or agencies should order COVID vaccines without confirming from NAFDAC if the vaccine has been approved.
According to her, “NAFDAC is discussing with manufacturers of candidate COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their product as the case may be.
“The Agency assures applicants that if Phase 3 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, NAFDAC will welcome the application for Emergency Use Authorisation in Nigeria.
“NAFDAC will use “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities. The full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) will be thoroughly reviewed by the Vaccine Committee that is made up of multiple Directorates in the Agency – Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services.”
