The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted that there are fake vaccines in circulation in Nigeria and warned unsuspecting members of the public to beware and do not order any vaccine online.
Announcing this was Prof Mojisola Christianah Adeyeye, Director General, in Zoom meeting with journalists, Friday who said that of the available global vaccines, including Moderna, AstraZeneca, only Pfizer Biotech has received emergency listing in the country.
Adeyeye stressed that it has neither received nor approve any COVID-19 vaccine from manufacturers for use in the country and warned against unauthorised orders.
The Director-General said, “NAFDAC agency has not received any application from COVID-19 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.”
Adeyeye strongly warned, “No government establishment or agencies should order COVID-19 vaccines without confirming from NAFDAC if the vaccine has been approved.”
However, she explained that NAFDAC 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.
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.
Emergency Use Authorisation, Licensing
Adeyeye further announced that
NAFDAC will use “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities.
She disclosed that the full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) will be thoroughly reviewed by the Vaccine Committee.
She said that the Vaccine Committee 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.
On post-marketing active Pharmacovigilance or phase 4 clinical trials, she said that the safety of the COVID-19 vaccine is premium to NAFDAC, noting that is why active pharmacovigilance is being used.
Her words, “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 to a 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 immunisation, 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 immunisation.” she added.
Details later.
Source: Independent.ng
