The National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria has caution the Nigerian communities and the surrounding countries to be vigilant over unofficail and unapproved COVID-19 vaccines circulating in the country.
Prof. Mojisola Adeyeye, director for NAFDAC, in a statement is warning government agencies, private companies and other corporations of self ordering of such unapproved vaccines by NAFDAC which the agency claims has bad side effect to human health, hence should not be used by the public.
Prof. Adeyeye, speaking to the Nigerian press on safety of the COVID-19 vaccines noted that manufacturers of these vaccines has failed to make submission of their produce of the COVID-19 vaccine to the NAFDAC for thorough investigations. hence appealing to genuine agencies who manufacturing these vaccines to seek for legal processes.
Adeyeye said, “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.”
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.