…says no vaccine has been approved in Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians to be wary of fake COVID-19 vaccines being circulated in the country. Giving the warning yesterday in Abuja, the Director General of NAFDAC, Prof. Mojisola Adeyeye, saidthevaccinescould cause other serious ailments capable of leading to death. She added that so far, the Agency was yet to receive or approve any COVID-19 vaccine application.
She further warned government and private establishments, including business organisations, not to order any COVID-19 vaccine without first engaging the Agency and getting authorisation to do so.
She said: “NAFDAC has not received any application from COVID Vaccine manufacturers yet and therefore no vaccines have been approved by NAFDAC. 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.
“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. “Vaccines should not be ordered by any company or corporation. The companies that manufacture the vaccines if they are genuine companies know they have to submit their application to NAFDAC. “No government establishment or agencies should order Covid vaccines without confirming from NAFDAC if the vaccine has been approved.
“However, NAFDAC is discussing with manufactures ofCOVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their product as the case may be. “The Agency is assuring 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 NAFDAC boss however noted that it could make use of “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities, after its full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) have been thoroughly reviewed by the Vaccine Committee made up of multiple Directorates in the Agency whose function revolves drug registration, regulation, evaluation, surveillance amongst others. Stressing the importance of post marketing active pharmacovigilance or phase 4 clinical trials, she said, “Safety of The Covid Vaccine Is Premium to NAFDAC This is why active pharmacovigilance is being used. Phase 4 pharmacovigilance is one of the core regulatory activities of the Agency.
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. “NAFDAC was positioned ta great extent to work online during the lockdown due to digitalization of many of our processes and continuous improvement.
“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, i.e., 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.”