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NAFDAC Approves AstraZeneca COVID-19 Vaccine For Use

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

Director General of NAFDAC, Prof. Mojisola Adeyeye made this known at a press briefing on Thursday in Abuja.

While noting that the vaccine can be stored at 2 to 8-degree centigrade.

She further stated that, the vaccine was recently approved by the WHO for emergency use, saying, 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.

While adding 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).

The NAFDAC Boss, however, stressed that the South African variant has not been reported in Nigeria, while the agency has over 30 herbal medicines undergoing review for listing.

According to her , the evaluation on Astrazeneca shows that the vaccine is effective against the United Kingdom variant of the virus which has been reported in Nigeria.
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 as summarized below.

Speaking on the quality of the vaccine, she said 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.

On the vaccine safety and efficacy,the NAFDAC boss hinted that from the Phases 2/3 conducted, 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

Adeyeye noted that, “the agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies. The App is free, and millions of healthcare workers can download it free for Adverse Drug Reaction (ADR) reporting. In-country training on the use of the App has begun for the healthcare givers.

“NAFDAC plans to also use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN). This is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion. This effort will create a reliable and predictable supply chain.

“At the continental level, NAFDAC is on the Regulators Steering Committee of African Union -3S (Smart, Safety Surveillance) with Ghana, South Africa and Ethiopia. The committee was formed as a preparatory caucus for safety monitoring of medicines but using COVID-19 vaccine as a pilot”.

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