NAFDAC approves AstraZeneca vaccine

NAFDAC approves AstraZeneca vaccine


Doosuur iwambe and Sharon Isaalah

National Agency for Food and Drug Administration and Control (NAFDAC) has approved the use of the Oxford/AstraZeneca COVID-19 vaccine in Nigeria.

Speaking during a briefing on Thursday, the Director-General of NAFDAC, Dr. Mojisola Adeyeye, said that the vaccine can be stored at 2 to 8-degree centigrade.

She also disclosed that there are three additional vaccines undergoing evaluation,. But the evaluation on Astrazeneca shows that the vaccine is effective against the UK variant of the virus which has been reported in Nigeria.

The NAFDAC boss noted that “the vaccine can be stored at two to eight degree centigrade temperature.

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“The active substance is manufactured and controlled by Serum Institute of India Private Limited (SIIPL). A GMP certificate and manufacturing licence 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 to 8 degree centigrade, one dose (0.5Ml) contains 5 x10) virus particle. On availability stability, the applicant has proposed a drug product shelf life of six months.

“On vaccine safety from the phases two and three conducted, COVISHIELD was found safe and well-tolerated in adults above 18 years of age.”

Adeyeye said that the focus was to use holistic approach for effective immunisation, including delivery of the vaccines and monitoring of any adverse effects.

She added that the multistakeholders technical working group had been meeting to address different issues, noting that the agency would use its recently launched Med Safety App for Active Pharmacovigilance of the vaccine.

Dr Adeyeye disclosed that the South African variant has not been reported in Nigeria, adding that the agency has over 30 herbal medicine undergoing review for listing.

The vaccine was recently approved by the W.H.O for emergency use, in a press briefing, NAFDAC says it got the dossier of the vaccine a week ago, and the NAFDAC safety committee went to work immediately to evaluate its safety and efficacy for Nigerians.

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).

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