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The National Agency for the Administration and Control of Food and Drugs (NAFDAC) has cautioned the public to be careful about using Nigeria’s bogus COVID-19 vaccines, saying they can cause COVID-like diseases and other serious diseases that could kill them.
Prof. Mojisola Adeyeye, Director General of the Department, who raised the alarm, also cautioned government departments and agencies, as well as private companies and large businesses, not to order vaccines without their approval, noting that COVID-19 vaccines are new and must be well monitored for side effects or adverse reactions, and should therefore not be used by the public.
While briefing journalists on the safety of vaccines through Zoom, Adeyeye said companies that produce the vaccines know they have to apply their application to NAFDAC if they are genuine, adding that no applications have yet been received by the regulatory agency from any manufacturers.
“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 insisted.
Recall that by the end of this month, the Presidential Task Force (PTF) on COVID-19 had previously announced that Nigeria would take delivery of the first phase of 100,000 doses of COVID-19 vaccines approved by Pfizer and BioNTech, with the Federal Government preparing to start administering the COVID-19 vaccine to Nigerians before the end of March.
According to the PTF, in the second step, Nigeria also expects to receive 42 million vaccine doses free of charge through the Global Vaccines Alliance (GAVI) administered COVAX facility.
However, in reaction to the anticipated vaccines, Adeyeye said Nigeria will only take delivery of the vaccines and begin to administer them when NAFDAC gives approval and green light for use, as administrative work needs to be done.
Adeyeye said that there are ongoing paper works to ensure the deadline is met at the NAFDAC meeting with the approval process before the delivery timeline by the end of this month, adding that in case there is a delay, it should be ready in a week or two weeks (February).
She claimed that, despite the approval of the World Health Organization (WHO) for the use of vaccines, they would not be used in Nigeria, unless they were authorized by her department, noting that NAFDAC was discussing with manufacturers of candidate COVID-19 vaccines the possible Emergency Use Authorization (EUA), registration or licensing of their product, while assuring applicants that if Phase 3 clinics were to be approved, they would not be used in Nigeria.
Adeyeye noted that ‘Reliance’ or ‘Recognition’ will be used by the Agency to expedite EUA for vaccines already authorised by more mature regulatory authorities, adding that the full dossier submitted by the manufacturer or market authorisation holder (MAH) would be thoroughly reviewed by the Vaccine Committee consisting of several NAFDAC Directorates, including Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services.
She said the protection of the vaccine is a NAFDAC premium, so active pharmacovigilance is being used, adding that one of the agency’s key regulatory tasks is Phase 4 pharmacovigilance.
The NAFDAC boss clarified that since the early phase of the pandemic around April last year, the organization has been planning for vaccinations and vaccination, adding that despite the use of ‘Reliance’ for the EUA, the clinical peculiarities in the form of severe or adverse effects following immunization (AEFIs) will be noted in the dossier or application as a reference and warning for what to look for in eactivation.
Adeyeye noted that the agency has been training its workers for this very important aspect of the immunization, and has formed 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 provide Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.
She said that NAFDAC has launched a multi-stakeholder partnership with the National Primary Health Care Development Agency (NPHCDA), the Nigerian Centre for Disease Control (NCDC), UNICEF, WHO and the Federal Ministry of Health to use a comprehensive approach to successful vaccine immunization or delivery and to track any AEFIs.
Adeyeye added that, in partnership with sister organizations, the department will also use its newly released free Med Protection App for Active Pharmacovigilance of vaccines.
Speaking on vaccine monitoring and tracking, Adeyeye announced that NAFDAC will use GS1 traceability to control the delivery of vaccines, using Global Trade Item Number (GTIN) to prevent fake vaccines from infiltrating the supply chain and ensure that no diversion occurs.
The initiative will establish a safe and predictable supply chain, she said, as the multi-stakeholder technical working group met to tackle various issues, from access to distribution to traceability of vaccines to monitoring of adverse effects after immunization.
SOURCE: THE GUARDIAN