Cautions against use of vaccines without Agency’s approvala
The National Agency for Food and Drug Administration and Control, NAFDAC, on Friday alerted of circulation of fake vaccines in Nigeria even as it disclosed that It has not approved any vaccines or receive any application from Covid Vaccine manufacturers yet.
The Agency also cautioned against the use of any vaccines without the agency’s approval.
Disclosing these during a virtual press conference, the Director-General of the Agency, Prof Mojisola Christianah Adeyeye, said “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.
Adeyeye who noted the unapproved ordering of covid vaccines by private companies and cooperations said: “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. ”
She maintained that 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 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.
“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 – Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services.
On clinical trials, Adeyeye said safety of the Covid Vaccine Is Premium to NAFDAC and that is why active pharmacovigilance is being used. She said the agency has been preparing for COVID-19 vaccines and vaccination since the early phase of the pandemic – around April 2020.
Continuing, Adeyeye added that 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.
She said the Agency has established COVID-19 Vaccine Committee that has been busy developing the guidelines and guidance.
“The Agency will also use its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies. The App is free, and millions of healthcare workers can download it free for ADR reporting. In-country training on the use of the App has begun for the healthcare givers.
“Tracking and Tracing of the Vaccines: NAFDAC plans to also use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN).
“The goal 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.
VANGUARD
