Prof. Mojisola Adeyeye, the Director General, National Agency for Food and Drug Administration and Control (NAFDAC) says the agency has not approved any COVID-19 vaccines. She made this known in a statement issued on Friday in Abuja.
She 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.’’
The director general, who restated the commitment of the agency toward guaranteeing drugs security, warned companies and corporate bodies against unapproved ordering of vaccines, noting 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 Authourisation (EUA), registration or licencing of their products as the case may be.”
Adeyeye, 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 World Health Organisation (WHO) emergency use listing.
She emphasised the commitment of NAFDAC in using “Reliance” or “Recognition” to expedite Emergency Use Authourisation (EUA) for vaccines already approved by mature regulatory authorities.
“The full dossiers submitted by manufacturer or Market Authourisation Holder (MAH) will be thoroughly reviewed by the Vaccine Committee that is made up of multiple directorates in the agency.”
The NAFDAC boss, who said that the agency would welcome the application for Emergency Use Authorisation in Nigeria, however, reiterated readiness to examine the safety of any vaccine.
She affirmed the collaboration of NAFDAC with sister agencies as National Primary Health Care Development Agency (NPHCDA), Nigeria Centre for Disease Control (NCDC), UNICEF, WHO and Ministry of Health, aimed at achieving 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 monitoring of adverse events following immunisation.
“NAFDAC is also a member of Regulators Steering Committee of African Union -3S (Smart, Safety, Surveillance) with Ghana, South Africa and Ethiopia, collaborating with UK Medicines Healthcare Products Regulatory Agency (MHRA) with funding from Bill and Melinda gates Foundation.
Adeyeye explained that the aim of the continental collaboration was to use COVID-19 vaccines distribution and immunisation as pilot to actively monitor the distribution, delivery and monitoring of Adverse Effects Following Immunisation at the continental level, aimed at creating an African-based vigilance system for safety of medicines. (NAN)