By Onche Odeh

Nigeria’s Food and Drug Regulator, the National Agency for Food and Drug Administration and Control (NAFDAC) has given approval for the use of COVISHIELD, the COVID-19 vaccine made by AstraZeneca/Oxford in the country.  This is happening eight days after the vaccine’s dossier was received.

In an announcement on Thursday, NAFDAC’s Director General, Prof Mojisola Adeyeye said the vaccine, a recombinant ChAdOx1 adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2 was given an approval for Emergency Use Listing by WHO on Monday, February 15, 2021, after its dossier was presented on February 10, 2021.

WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

With the Emergency Use Listing, Nigeria can now receive the first batch of the vaccine from COVAX Facility within weeks. This is however, subject to approval by NAFDAC.

The agency had in January cautioned the pubic against circulation of fake COVID vaccines, stating then that it had not granted approval for the use of any of such vaccines to any company warning also that no government establishment or agencies should place order for COVID vaccines without confirming from them even if the vaccine has been approved for use.

The agency’s DG disclosed during the press conference on Thursday that the approval for the use of AstraZeneca/Oxford COVID-19 vaccine followed the requisite due process and was guided by series of consultations both locally and internationally.

Prof Adeyeye, DG NAFDAC

Prof. Adeyeye disclosed that the approval was sequel to the authentication and validation of a Global Manufacturing Practice (GMP) certificate and manufacturing license issued by the India National Regulatory Authority (NRA) that was presented by Serum Institute of India Private Limited (SIIPL), manufacturer of the active substance for the vaccine.

“NAFDAC received the AstraZeneca/Oxford COVID-19 vaccine dossier from Serum Institute of India on February 10, 2021 and 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,” Prof Adeyeye said.

While vouching for the safety and efficacy of the vaccine, the NAFDAC DG said, “From the Phases 2/3 conducted, COVISHIELD was found safe and well-tolerated in adults above 18 years of age. The incidence of solicited, unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) was comparable in the study control groups. No causally related SAE was caused by the study vaccine.”

Meanwhile, NAFDAC has initiated a multi-stakeholder collaboration with National Primary Health Care Development Agency (NPHCDA), Nigeria Center for Disease Control (NCDC), UNICEF, GAVI, WHO and Ministry of Health to use a holistic approach for the effective delivery of the vaccines and monitoring of Adverse Events Following Immunisation (AEFI).  The multi-stakeholder technical working groups have been meeting to address different issues, from access to distribution to traceability (track and trace) of the vaccines, to monitoring of adverse events following immunization.

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