Fake COVID-19 Vaccines in Nigeria, NAFDAC Warns
The National Agency for Food and Drug Administration and Control (NAFDAC) has warned against the use of any COVID-19 vaccine it has not approved, saying there are fake ones in circulation, even before the 10million real doses of the shots expected later in March.
NAFDAC’s director-general, Prof Moji Adeyeye, said during an emergency webinar conference on Friday that “There are reports of fake vaccines in Nigeria. 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,”
The NAFDAC boss said the agency is yet to receive any application from COVID-19 vaccine manufacturers, saying it has therefore not approved any vaccines.
According to her, COVID-19 vaccines are new, and the side effects or adverse effects must be well monitored, adding that “if NAFDAC does not approve, the public should not use.”
She warned against ordering of COVID-19 vaccines by any company or corporation, saying that if the companies that manufacture the vaccines are genuine, they know that they have to submit their application to NAFDAC.
Adeyeye also cautioned government establishments and agencies against ordering COVID-19 vaccines without confirming from NAFDAC if they have been approved.
She however noted that NAFDAC was discussing with manufacturers of COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their product as the case may be.
She added: “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.”
Speaking further, Adeyeye said that the Agency was collaborating with sister agencies and partners, while also expressing its plans to use the traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN).
The goal, she said, 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 explained.
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