•Cautions FG, corporate agencies against ordering vaccine without approval
•Insists NAFDAC must give go ahead for vaccine usage in Nigeria, despite WHO approval
•Agency to track, trace, monitor vaccine distribution with technology
The National Agency for Food and Drug Administration and Control (NAFDAC) has warned the public to be wary of using the fake COVID-19 vaccines circulating in Nigeria, saying they can cause COVID-like illnesses and other serious diseases that could kill.
Director General of the agency, Prof. Mojisola Adeyeye, who raised the alarm, also warned government establishments and agencies, as well as private companies and big corporation, against ordering the vaccines without its approval, noting that COVID-19 vaccines are new and the side effects or adverse events must be well monitored; hence should not be used by the
Adeyeye, while briefing journalists on the safety of the vaccines via Zoom, said companies that manufacture the vaccines know they have to submit their application to NAFDAC if they are genuine, adding that the regulatory agency has not received any application from any manufacturers ye
“There are reports of fake vaccines in Nigeria and these vaccines can cause COVID-like illnesses or other serious diseases that could kill. No government establishment or agencies, company or corporation should order COVID-19 vaccines without confirming from NAFDAC if the vaccines have been approved.
“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,” she said
Recall that the Presidential Taskforce (PTF) on COVID-19 had earlier said Nigeria would take delivery of the first phase of 100,000 doses of the Pfizer and BioNTech approved COVID-19 vaccines by the end of this month, with the Federal Government planning to begin administering of the COVID-19 vaccine on Nigerians before the end of March.
According to the PTF, Nigeria also expects to receive free 42 million doses of vaccines in the second phase through the COVAX facility being administered by the Global Vaccines Alliance (GAVI).
But reacting to the expected vaccines, Adeyeye said Nigeria would only take delivery and begin administering of the vaccines when NAFDAC gives approval and green light for use, as there are administrative work that needs to be done.
On NAFDAC meeting up with the process of approval before the timeline of delivery by the end of this month, Adeyeye said there are ongoing paper works to ensure the timeline is met, noting that incase there is a delay, it should be ready in a week or two weeks (February).
She said despite approval for the use of the vaccines by the World Health Organisation (WHO), they would not be used in Nigeria, except they are approved by her agency, noting that NAFDAC was discussing with manufactures of candidate COVID-19 vaccines concerning potential Emergency Use Authorisation (EUA), registration or licensing of their product, while 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 to WHO for Emergency Use Listing, NAFDAC would welcome the application for EUA in Nigeria.
Adeyeye said the agency would use “Reliance” or “Recognition” to expedite EUA for vaccines already approved by more matured regulatory authorities, adding that the full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) would be thoroughly reviewed by the Vaccine Committee made up of multiple directorates of NAFDAC, which are the Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services.
She said safety of the vaccine is premium to NAFDAC hence active pharmacovigilance is being used, adding that the Phase 4 pharmacovigilance is one of the core regulatory activities of the agency.
The NAFDAC boss explained that the agency has been preparing for the vaccines and vaccination since the early phase of the pandemic around April last year, noting that despite the use of “Reliance” for the EUA, it would 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, that is, during the active pharmacovigilance phase, where monitoring of adverse events would be conducted.
Adeyeye stated that the agency has been training its staff for this very important aspect of the immunization, and has established COVID-19 Vaccine Committee, which has been busy developing the guidelines and guidance, adding that NAFDAC is the first national regulatory agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.
She said NAFDAC has initiated multi-stakeholder collaboration with National Primary Health Care Development Agency (NPHCDA), Nigeria Centre for Disease Control (NCDC), UNICEF, WHO and the Federal Ministry of Health to use a holistic approach for the effective immunisation or delivery of the vaccines and monitor any AEFI.
Adeyeye added that the agency would also use its recently launched free Med Safety App for Active Pharmacovigilance of the vaccines, in collaboration with sister agencies.
Speaking on tracking and tracing of the vaccines, Adeyeye disclosed that NAFDAC would use the traceability with GS1 technology to monitor the vaccine distribution, using Global Trade Item Number (GTIN) to prevent fake vaccines from infiltrating the supply chain and ensure there is no diversion.
She said the effort would create a reliable and predictable supply chain, as the multi-stakeholder technical working group has been meeting to address different issues, from access to distribution to traceability (track and trace) of the vaccines to monitoring of adverse events following immunisation.