The National Agency for Food and Drug Administration and Control (NAFDAC) has warned of fake covid-19 vaccines in Nigeria, saying these vaccines can cause Covid-like illnesses or other serious diseases that could kill.
Director-General, NAFDAC, Professor Mojisola Adeyeye who disclosed at a virtual press briefing on Friday, said the agency has not received any application from Covid Vaccine manufacturers yet and therefore no vaccines have been approved by NAFDAC.
According to her, “There are reports of fake vaccines in Nigeria. NAFDAC is pleading with the public to beware. 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.”
Adeyeye said, “no government establishment or agencies should order Covid vaccines without confirming from NAFDAC if the vaccine has been approved.”
According to her, “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 declared 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.
She assured 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.
Professor Adeyeye, however, assured that NAFDAC will use “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities.
She added, “Safety of the Covid vaccine is premium to NAFDAC. This is why active pharmacovigilance is being used. 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.”
The NAFDAC DG declared that the Agency has been preparing for the COVID-19 vaccines and vaccination since the early phase of the pandemic – around April 2020, even as it was the first agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.
She, however, said that in collaboration with National Primary Health Care Development Agency (NPHCDA), Nigeria Center for Disease Control (NCDC), UNICEF, WHO and Ministry of Health, the agency’s focus is to use a holistic approach for the effective immunization or delivery of the vaccines and monitor any Adverse Events Following Immunisation (AEFI).
Professor Adeyeye said NAFDAC will be tracking and tracing COVID-19 vaccines with GS1 technology to prevent fake vaccines from infiltrating the supply chain, to ensure there is no diversion and to create a reliable and predictable supply chain.