COVID-19 Vaccine: NAFDAC develops guidance, guideline for regulatory preparedness

By Promise Godfrey, Abuja

The National Agency for Food and Drug Administration and Control (NAFDAC) has developed guidance and guidelines on the regulatory preparedness for Emergency Use Authorization (EUA) licencing or access to COVID-19 vaccines.

The Director General (DG), NAFDAC, Prof. Mojisola Adeyeye who disclosed this on Thursday in Abuja, noted that the agency has been preparing for COVID-19 vaccines and vaccination since the early phase of the pandemic around April, 2019.

According to the DG, global meetings have been held continuously since April with focus on understanding the disease and the advent of the vaccines.

Prof. Adeyeye revealed that she has had meetings with International Coalition of Medicine Regulatory Authorities (ICMRA) while respective Directors and staff have been meeting with WHO, African Medicine Regulatory Harmonization (AMRH), WA-MRH, AVAREF, among others

She said,”The Agency established the COVID-19 Vaccine Committee and has been busy developing guidelines and guidance. NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preperadness for EUA, Licencing or Access to COVID-19 Vaccines.

“The guidance addressed many regulatory issues including the following; submission of dossiers by manufacturers and market authorization holder, assessment of dossier through different mechanisms and using the common technical document for the rolling submission, (Emergency Use Authorization, Expedited approval, full review, Post-marketing Pharmacivigilance and Surveillance).

“Finally, NAFDAC received the AstraZeneca/OxdordCOVID-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 DG stressed that the recommendation for Emergency Use Authorization was based on rigorous scientific considerations which include Vaccine quality, Vaccine Safety and Efficacy, and Pharmacovigilance of COVID-19 vaccines.

She assured that 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 began for the healthcare givers

“NAFDAC plans to also use the Traceability with GSI technology to monitor the vaccine distribution using Global Trade Item Number (GTIN). This 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.

“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 causes for safety monitoring of medicines but using  COVID-19 vaccine as a pilot,” she said.