The National Agency for Food and Drug Administration and Control (NAFDAC) on Friday said it had not received any application from COVID-19 vaccine manufacturers and therefore no vaccine has been approved by it to treat patients infected with the virus.
The Director General of the agency, Prof. Mojisola Adeyeye, in a statement, warned Nigerians, especially those being treated for the virus, not to use any vaccine in the market now given the potential advert effects on their health.
Prof. Adeyeye noted that reports indicated that there were fake vaccines in Nigeria, adding that her agency is pleading with the public to beware as administration of fake vaccines can cause COVID-like illnesses or other serious diseases that could kill.
On the risks associated with ordering of unapproved COVID-19 vaccines by private companies into the country, the renowned pharmacist cautioned that vaccines should not be ordered by any company or corporation without NAFDAC’s approval of their applications to the effect.
She warned: “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”, Prof. Adeyeye added.
On emergency use authorization and licensing, the Director General said NAFDAC would use “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities.
According to her, 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.
In addition, the Director General said the agency placed high premium on safety of COVID-19 vaccines for patients in Nigeria, hence its use of active pharmacovigilance or Phase 4 Active Trial for post-marketing activities nationwide as part of its core regulatory activities.
She expatiated: “For COVID-19 vaccines, the Agency has been preparing for the COVID-19 vaccines and vaccination since the early phase of the pandemic – around April 2020. NAFDAC was positioned to a great extent to work online during the lockdown due to digitalization of many of our processes and continuous improvement.
“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. The agency has been training her staff for this very important aspect of the immunization”, she added.
On the agency’s collaboration with other agencies and partners, Prof. Adeyeye said NAFDAC initiated multi-stakeholder collaboration with National Primary Health Care Development Agency (NPHCDA), Nigeria Center for Disease Control (NCDC), UNICEF, WHO and Ministry of Health as part of efforts to use a holistic approach for the effective immunization or delivery of the vaccines and monitor any Adverse Events Following Immunisation (AEFI).
This is even as she assured that the agency would also use its recently launched Med Safety App for Active Pharmacovigilance of the vaccines, in collaboration with the sister agencies.
The Director General said that the App was being offered for use at no cost and that 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.
Prof. Adeyeye further hinted that the agency planned 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. 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 immunization”, the Director General added
On the agency’s relationship with similar agencies in Africa, she said tha NAFDAC had become a member of the Regulators Steering Committee of African Union -3S (Smart, Safety Surveillance) with Ghana, South Africa and Ethiopia.
According to her, the Steering Committee is collaborating with UK Medicines Healthcare Products Regulatory Agency (MHRA) through funding from Bill and Melinda Gates Foundation.
“The composition of the Nigeria’s working group (a regulatory officer from NAFDAC and an officer from NPHCDA) was used as a template for the AU-3S which the three other African regulators have adopted. The active pharmacovigilance that will be carried out will be used to harness data in MHRA database for detection of signals, understanding of demographic differences, etc”, Prof. Adeyeye said.
