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By Doris Obinna and Fred Ezeh
National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm on fake COVID-19 vaccines circulating in Nigeria, pleading with the public to beware and avoid it.
The agency said it has neither received any application from COVID-19 vaccine manufacturers nor approved any one for use in Nigeria, warning that administering fake vaccines could cause Covid-like illnesses or other reactions that could lead to death.
Director General of NAFADC, Prof. Mojisola Adeyeye, who issued the warning on Friday during a webinar meeting with journalists, warned individuals and corporations against private ordering of the vaccines that are not approved by it.
According to her, “No government establishment, agencies or corporations should order COVID-19 vaccines without confirming from NAFDAC if the vaccine has been approved. The manufacturers know that they have to submit their application to NAFDAC if they are genuine.
“However, we are discussing with manufacturers of COVID-19 vaccines concerning potential Emergency Use Authorization (EUA) for registration or licensing of their product as the case may be. If phase 3 clinical data are very convincing and robust with regards to safety and efficacy, and the vaccines submitted to WHO for Emergency Use Listing, NAFDAC will welcome the application for EUA in Nigeria.
“Nevertheless, we planned to commence tracking and tracing of the vaccines. We will use our traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN). The aim is to create a reliable and predictable supply chain.”
The NAFDAC boss said the agency will use “reliance” or “recognition” to expedite 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 made up of multiple Directorates in the Agency, notably, Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services”, she explained.
She said that, despite the use of EUA, NAFDAC will note clinical peculiarities in form of Serious or Adverse Events Following Immunisation (AEFIs) in the dossier or application as a guide and caution for what to look out for in each subject after immunization, that is, during the active pharmacovigilance phase where monitoring of adverse events will be conducted.
