BY Victoria Ogunrinde
The Director General, National Agency for Food and Drug Administration Control (NAFDAC), Prof. Mojisola Adeyeye, on Friday said the agency has not approved any COVID-19 vaccines.
Adeyeye who disclosed this in a statement issued in Abuja, stated that the agency had not received any application from vaccine manufacturers “and therefore, no vaccine had been approved by NAFDAC.
“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 must be monitored.
“No COVID-19 vaccines have been approved by NAFDAC. Fake vaccines can cause COVID-like illnesses or other serious diseases that can kill.’’
Adeyeye while reiterating the agency’s commitment toward guaranteeing drugs security, however warned companies and corporate bodies against unapproved ordering of vaccines, adding that genuine manufacturing companies had to submit applications to NAFDAC first.
“No government establishment or agencies should order for COVID-19 vaccines without confirming from NAFDAC.
“However, NAFDAC is discussing with manufacturers of candidate COVID-19 vaccines concerning potential Emergency Use Authorisation (EUA), registration or licencing of their products as the case may be.”
The agency’s Boss, however, assured applicants of NAFDAC’s determination to approve vaccines for emergency use if phase three clinical data were convincing and robust with regards to safety and efficacy, and the vaccine had been submitted for the World Health Organisation (WHO) emergency use listing.
She emphasised the commitment of NAFDAC in using “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by mature regulatory authorities.
“The full dossiers 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.”
Similarly, Prof. Adeyeye stated that the agency would welcome the application for Emergency Use Authorisation in Nigeria, however, reiterated readiness to examine the safety of any vaccine.
She also affirmed the collaboration of NAFDAC with sister agencies such as the National Primary Health Care Development Agency (NPHCDA), Nigeria Centre for Disease Control (NCDC), UNICEF, WHO and the Ministry of Health, aimed at achieving a holistic approach for effective immunisation and delivery.
“NAFDAC plans to also use Traceability with GS1 Technology to monitor 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 to the monitoring of adverse events following immunisation,” she said.