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COVID19 Vaccine: NAFDAC Cautions Against Fake Vaccines

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.

Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof Mojisola Christianah Adeyeye


Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof Mojisola Christianah Adeyeye

”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.

 

 

 

 


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Comments

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