The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the emergency use listing (EUL) of AstraZeneca vaccine, also known as Covishield, manufactured under licence by Serum Institute of India.
The agency explained that its vaccine committee expedited the review of the AstraZeneca vaccine based on the EUL given by the World Health Organisation (WHO) on February 15, 2021.
This is coming as distribution of the coronavirus vaccine across the African continent is to begin next week, according to the Africa Centres for Disease Control and Prevention (CDC).
Outcomes of NAFDAC’s review showed that Covishield was found safe and well-tolerated in adults above 18 years of age. Also, the multi-dose (two doses or 10 doses) can be stored at 2 to 8 degree centigrade, which is environmentally suitable in Nigeria.
This makes NAFDAC the first agency in Africa to have guidance on emergency use listing of COVID-19 vaccines.
Its Director General, Prof. Mojisola Adeyeye, who stated these at a media briefing in Abuja, said: “The use of AstraZeneca/Oxford COVID-19 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.
“WHO’s 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.
“The National Agency for Food and Drug Administration and Control has been preparing for the COVID-19 vaccines and vaccination since the early phase of the pandemic — around April 2020. NAFDAC was positioned to a great extent to work online during the lockdown due to digitalisation of many of our processes and continuous improvement.
“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 Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.”