COVID19: NAFDAC Cautions Against Fake Vaccines In Nigeria
15 January 2021 Health
As Countries that are members of the COVAX Facility have access to vaccines and immunize their population’s priority groups, the National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned Nigerians against Covid-19 vaccines not approved by the agency.
The Director-General of the Agency, Prof Mojisola Adeyeye, during a virtual media conference observed that there are reports of fake vaccines in Nigeria. hence the need for Nigerians to be cautious.
”NAFDAC is pleading with the public to beware. No Covid Vaccines have been approved by NAFDAC. Fake vaccines can cause Covid-like illnesses or other serious diseases that could kill. “
“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 said.
According to her, ” No government establishment or agencies should order Covid vaccines without confirming from NAFDAC if the vaccine has been approved.”
Prof Adeyeye, however said the agency was discussing with manufactures 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.”
The NAFDAC DG, who said the agency was positioned to a great extent to work online during the lockdown due to digitalization of many of the processes and continuous improvement. that safety of the Covid Vaccine was Premium to NAFDAC.
“The Agency established COVID-19 Vaccine Committee that has been busy developing the guidelines and guidance. NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.” she added.