The National Agency for Food and Drug Administration and Control (NAFDAC) has raised alarm over fake COVID-19 vaccines in circulation in the country.
Speaking during a virtual press conference on Friday, the Director General of the agency, Prof. Mojisola Adeyeye, enjoined the public to be wary of them.
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She said the agency has not received any application from COVID vaccine manufacturers yet and therefore no vaccines have been approved by it.
She said: “There are reports of fake vaccines in Nigeria.
“NAFDAC is pleading with the public to beware.
“No COVID-19 vaccines have been approved by NAFDAC.
“Fake vaccines can cause COVID-like illnesses or other serious diseases that could kill.
“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.”
She said vaccines should not be ordered by any company or corporation, adding that the companies that manufacture the vaccines, if they are genuine, know they have to submit their application to NAFDAC.
Prof. Adeyeye also said no government establishment or agencies should also order COVID-19 vaccines without confirming from NAFDAC if the vaccines have been approved.
She 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,” she said.
While saying that NAFDAC would use “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities, she said the full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) would be thoroughly reviewed by the vaccine committee that is made up of multiple directorates in the agency.
Safety of the COVID-19 vaccine
She said the safety of the COVID-19 vaccine is premium to NAFDAC, and active pharmacovigilance was being used.
“Despite the use of Reliance for the 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.
“The Agency has been training her staff for this very important aspect of the immunization,” she added .
NAFDAC to monitor distribution
The NAFDAC boss said the agency plans to also track and trace the COVID-19 vaccines using the traceability with GS1 technology to monitor distribution with Global Trade Item Number (GTIN).
“The goal is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion.
“This effort will create a reliable and predictable supply chain.
“The multi-stakeholder technical working group has been meeting to address different issues, from access to distribution to traceability (track and trace) of the vaccines, to monitoring of adverse events following immunization,” she said.
