The National Agency for Food and Drug Administration and Control, NAFDAC, on Thursday approved the emergency use of AstraZeneca vaccine, EUL, also known as Covishield, manufactured under license by Serum Institute of India.
The agency explained its vaccine committee expedited the review of the AstraZeneca vaccine based on the EUL given by the World Health Organization (WHO) on the 15th of February, 2021.
Outcomes of its review showed that Covishield was found safe and well tolerated in adults above 18 years.
Also, the multidose (2 dose or 10 dose) can be stored at 2 to 8 degree centigrade, which is environmentally suitable in Nigeria.
This makes NAFDAC the first in Africa to have guidance for emergency use listing of COVID-19 vaccines.
The Director General of the NAFDAC, Prof Mojisola Adeyeye, made these known during a briefing in Abuja.
She said: “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 digitalization 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.”
Mrs Adeyeye added: “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.
“The active substance is manufactured and controlled by Serum Institute of India Private Limited. A GMP certificate and manufacturing licence issued by Indian National Regulatory Authority has been presented and found to be authentic and valid.
“The multidose (2 dose or 10 dose) vial is stored at 2 to 8 degree centigrade, one dose (0.5ml) contains 5 x 10° virus particle. On available stability data, the applicant has proposed a drug product shelf-life of six months.
“Covishield was found safe and well-tolerated in adults above 18 years of age. The incidence of solicited, unsolicited AEs and SAEs was comparable in the study control groups. No causally related SAE was caused by the study vaccine.”
