The National Agency for Food,Drug Administration and Control, NAFDAC says the AstraZeneca/Oxford COVID-19 vaccine is effective against the variant of the coronavirus first discovered in the UK, several cases of which had been reported in Nigeria.
This was made known by NAFDAC Director-General, Prof. Mojisola Adeyeye during a media briefing after Announcing the approval of the vaccine. Adeyeye who said the agency obtained the dossier of the vaccine last week, added that its safety committee immediately began evaluating its safety and efficacy for Nigerians.
She also noted that the recommendation for emergency use authorisation was based on rigorous scientific considerations.
According to her: “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 active substance is manufactured and controlled by Serum Institute of India Private Limited (SIIPL). A GMP certificate and manufacturing license issued by the India National Regulatory Authority (NRA) has been presented and found to be authentic and valid.
“The multidose (2 dose or 10 dose) vial is stored at 2-8 degrees Centigrade, 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, Covisheild 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.
“Safety of the vaccine is premium to NAFDAC and a lot of efforts are being put into this regulatory function. The agency initiated multi-stakeholder collaboration with National Primary Health Care Development Agency, NPHCDA, Nigeria Centre for Disease Control, NCDC, UNICEF, GAVI, WHO and Ministry of Health.