The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the emergency use of Oxford/AstraZeneca COVID-19 vaccine in the country.
The vaccine was recently approved by the W.H.O for emergency use.
Director-General of NAFDAC, Dr. Mojisola Adeyeye who announced this yesterday in Abuja NAFDAC observed that the agency got the dossier of the vaccine a week ago adding that the NAFDAC safety committee went to work immediately to evaluate its safety and efficacy for Nigerians.
She explained that the Oxford/AstraZeneca vaccine, also known as ChAdOx1 nCoV-19, or AZD1222, is a viral vector vaccine. Scientists used an adenovirus, originally derived from chimpanzees, and modified it with the aim of training the immune system to mount a strong response against SARS-CoV-2 (the virus that causes COVID-19).
Adeyeye noted that the recommendation for Emergency Use Authorization was based on rigorous scientific considerations such as vaccine quality, vaccine safety and efficacy, dose pack and storage.
She stated that the active substance for the vaccine is manufactured and controlled by the 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 NAFDAC boss said that the multidose (2 doses or 10 doses) vial is stored at 2-8OC, one dose (0.5ml) contains 5 x 1010 virus particle. On available stability data, the applicant has proposed a drug product shelf life of 6 months.