The Director-General, National Agency for Food and Drug Administration and Control (NAFDAC), says the agency has not approved any COVID-19 vaccines for Nigeria just yet.
NAFDAC’s DG Mojisola Adeyeye, made this known in a statement issued on Friday in Nigeria’s capital Abuja.
She stated that no application from vaccine manufacturers had been received by the agency “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 vaccine has been approved by NAFDAC. Fake vaccines can cause COVID-like illnesses or other serious diseases that can kill.’’
While reiterating the commitment of the agency toward guaranteeing drugs security, the DG warned companies and corporate bodies against the unapproved ordering of any vaccine, noting that genuine manufacturing companies had to first submit applications to NAFDAC.
“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 Authorization (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 the World Health Organisation (WHO) emergency use listing.
She laid emphasis on the commitment of the agency in using “Reliance” or “Recognition” to expedite Emergency Use Authorization (EUA) for vaccines that already have been 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.”
The NAFDAC boss reiterated readiness of the agency to examine the safety of any vaccine before being approved for Nigerians.
She affirmed NAFDAC’s collaboration with sister agencies 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.
“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 concluded by explaining that the purpose of the continental collaboration was to use COVID-19 vaccines immunisation and distribution as a pilot to actively monitor the distribution, delivery and monitoring of Adverse Effects Following Immunisation at the continental level, targeted at creating an African-based vigilance system for the safety of medicines.