NAFDAC says it has not approved any COVID-19 vaccines for public use

The National Agency for Food Drug Administration and Control (NAFDAC) has warned that it has not approved any vaccines for public use or received any application from vaccine manufactures for emergency use authorisation in Nigeria.

The agency also warned that there are reports of fake vaccines currently in circulation in Nigeria, capable of causing severe illness or death, and urged Nigerians to beware.

Mojisola Adeyeye, director-general, NAFDAC, who gave this warning at a virtual news briefing on Friday, frowned at reports that some government agencies and private companies plan on ordering Covid-19 vaccines without its approval.

“No government establishment or agencies should order vaccines without confirming from NAFDAC if the vaccines have been approved. Vaccines should not be ordered by any agency or corporation,” she warned.

Adeyeye explained that the approval by WHO for emergency use of some of these vaccines was not enough and, therefore, such vaccines must be subject to NAFDAC approval before they could be administered to Nigerians.

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“That WHO approves it for emergency use is not enough; no vaccine should be used unless it is subject to NAFDAC approval,” Adeyeye said.

“The companies that manufacture the vaccines, if they are genuine, know they have to submit applications to NAFDAC,” she said.

She, however, informed that NAFDAC was in talks with manufacturers of candidate COVID-19 vaccines concerning potential emergency use authorisation (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,” the DG said.

She further informed that NAFDAC is preparing to do tracking and tracing of the vaccines using Global Trade Item Number (GTIN), 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 immunisation,” she said.