The National Agency for Food and Drug Administration and Control (NAFDAC) has granted emergency use authorization to the coronavirus vaccine made by AstraZeneca and Oxford University.
Director general of the agency, Prof Moji Adeyeye, made the disclosure while briefing newsmen in Abuja on Thursday.
Prof Adeyeye said the agency has been preparing for the COVID-19 vaccines and vaccination since April 2020.
She said the agency established the COVID-19 Vaccine Committee and has been busy developing guidelines and guidance, adding that NAFDAC is the first national regulatory agency in Africa to have guidance on regulatory preparedness for EUA, licensing or access to COVID-19 vaccines.
She said, “Finally NAFDAC received the AstraZeneca/Oxford COVID-19 vaccine dossier from Serum Institute of India on February 10, 2021.
“The NAFDAC Vaccine Committee commenced the expedited review immediately and the members of the committee have worked assiduously to ensure that review was done as planned. The recommendation for Emergency Use Authorization was based on rigorous scientific considerations.”
She said some of the considerations for the recommendation include vaccine quality, safety and efficacy and pharmacovigilance.
The World Health Organisation (WHO) had on Monday granted approval for emergency use listing of the vaccine.
WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply.
It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. The EUL will allow Nigeria to receive the first batch of the vaccine from COVAX Facility within weeks subject to approval by NAFDAC.
Prof Adeyeye said the agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies.
“The App is free, and millions of healthcare workers can download it free for Adverse Drug Reaction (ADR) reporting. In-country training on the use of the App has begun for the healthcare givers,” she said.
The NAFDAC boss said the agency also plans to use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN).
According to her, this will prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion.
“At the continental level, NAFDAC is on the Regulators Steering Committee of African Union -3S (Smart, Safety Surveillance) with Ghana, South Africa and Ethiopia. The committee was formed as a preparatory caucus for safety monitoring of medicines but using COVID-19 vaccine as a pilot,” she added.
