COVID Vaccine: Nigeria’s Drug Regulator To Grant Conditional Emergency Use Authorisation

By Onche Odeh

Nigeria’s Food and Drug Regulator, National Agency for Food and Drug Administration and Control (NAFDAC) has said it is 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. This would, however, be based on results from Phase 3 clinical trials of the candidates vaccines.

For vaccines that have already been approved by more matured regulatory authorities, the Agency says it will use ‘Reliance’ or ‘Recognition’ to expedite Emergency Use Authorisation (EUA).

In a statement issued on Thursday, the Director General of NAFDAC, Professor Mojisola Adeyeye, however, assured applicants that if Phase 3 clinical data for their candidate vaccines 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.

Giving further conditions for authorization of vaccine usage in Nigeria, Prof Adeyeye said, “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.”

According to her the use of Reliance for the EUA, NAFDAC will take note of 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.

“Safety of the Covid Vaccine Is Premium to NAFDAC. This is why active pharmacovigilance is being used,” the NAFDAC DG stated, adding that Phase 4 pharmacovigilance is one of the core regulatory activities of the Agency.

Prof Adeyey disclosed that NAFDAC, has been training her staff for this very important aspect of the immunization.

“For COVID-19 vaccines, the Agency has been preparing for the COVID-19 vaccines and vaccination since the early phase of the pandemic, around April 2020,” she stated.

Meanwhile, NAFDAC says it was yet to received any application from Covid Vaccine manufacturers, hence no vaccines have been approved by it for use in Nigeria.

Similarly, the Agency has cautioned the public to be wary of fake vaccines in Nigeria, stating that fake vaccines can cause Covid-like illnesses or other serious diseases that could kill.

The DG has also warned that vaccines should not be ordered by any company or corporation, saying The companies that manufacture the vaccines if they are genuine companies know they have to submit their application to NAFDAC.

In the same vein, Prof Adeyeye has said that no government establishment or agencies should order Covid vaccines without confirming from NAFDAC if the vaccine has been approved.

NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.







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