The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the emergency use of the AstraZeneca/Oxford COVID-19 (Covishield) vaccine in Nigeria. Director-General of NAFDAC, Prof. Mojisola Adeyeye, who made the disclosure while briefing newsmen yesterday, in Abuja, gave assurances that the vaccine had been proven safe and effective by the safety committee which went to work about a week ago, immediately after Nigeria got the dossier of the vaccines.
Adeyeye, who noted that the vaccine could be stored at 2 to 8 degree Centigrade, explained that the Oxford/ AstraZeneca vaccine, also known as ChAdOx1 nCoV- 19, or AZD1222, was an adenoviral vector encoding the structural surface glycoprotein (spike protein) antigen of the SARSCOC- 2.
She added that there were three additional vaccines presently undergoing evaluation, with over 30 herbal medicines undergoing review for listing by NAFDAC. While maintaining that the evaluation of the Oxford/ AstraZeneca vaccine also proved its effectiveness against the United Kingdom’s variant of the coronavirus reported to be present in Nigeria, she, however, clarified that the South African variant was yet to be reported in Nigeria. She said: “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 as summarized below. “The multidose (2 dose or 10 dose) vial is stored at 2-8 C, one dose (0.5ml) contains 5 x 1010 virus particle. On available stability data, the applicant has proposed a drug product shelf life of six months. “From the Phases 2/3 conducted, COVISHIELD was found safe and welltolerated 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.”