The Ministry of Food and Drug Safety announced that today (4th) AstraZeneca in Korea received an application for product permission for the Corona 19 vaccine'AZD1222' and started the review.
The vaccine applied for permission this time is a'viral vector vaccine' manufactured by putting the corona 19 virus surface antigen gene into a chimpanzee adenovirus template.
It is the same method as the Janssen (Johnson & Johnson) vaccine.
The expected target of the AstraZeneca vaccine is 18 years of age or older, and the expected use is 2 doses 4 to 12 weeks after 1 vaccination.
Storage conditions are 2-8℃.
The Ministry of Food and Drug Safety plans to complete the AstraZeneca vaccine review by shortening the approval review process that takes more than 180 days to less than 40 days.
The Ministry of Food and Drug Safety explained that it has undertaken a preliminary review of non-clinical and quality data at the request of AstraZeneca in Korea.
Non-clinical data were requested to be supplemented, and quality data are being reviewed in advance.
AstraZeneca is currently undergoing phase 3 clinical trials in 10 countries including the UK, Brazil and the US.
In September of last year, the clinical trial was suspended due to an unexpected abnormal case, but as a result of safety review, the clinical trial was resumed because there was no direct relationship with the vaccine.
The UK confirmed the preventive effect on 11,636 people in the AstraZeneca vaccine clinical trial and approved it for emergency use on December 30 last year.
The European Medicines Agency (EMA) has been conducting preliminary reviews on the product since October last year.
AstraZeneca is also pursuing a global vaccine supply procedure, such as applying to be listed on the World Health Organization's (WHO) Emergency Use List (EUL).
Korea's AstraZeneca applied simultaneously to SK Bioscience, a domestic pharmaceutical company, for'manufacturing and sales' permission for products that are consigned and'imported items' for products manufactured overseas such as Italy.
Currently, SK Bioscience is consigned from AstraZeneca and additionally submits quality data on the original vaccines and finished drugs produced in Korea to the AstraZeneca headquarters.
The headquarters of AstraZeneca will analyze the quality equivalence of the clinical trial vaccine and the domestic consigned vaccine, and then publish this data to the Ministry of Food and Drug Safety.
The Ministry of Food and Drug Safety plans to shorten the approval review period by first reviewing quality data other than comparison data between manufacturing sites while the data is being prepared.
We plan to receive additional data on the analysis of abnormal cases of vaccine through 12-month follow-up.
The Ministry of Food and Drug Safety explained that SK Bioscience is preparing to approve the national shipment of AstraZeneca vaccine, which is consigned by SK Bioscience.
National Shipment Approval is a system that verifies the quality of products through verification tests and data review in the country for each manufacturing unit.
In addition to product approval, vaccines require national shipping approval to verify quality before sale.
Corona 19 vaccine is subject to expedited shipment approval and is processed before other national shipment approval drugs.
The Ministry of Food and Drug Safety plans to complete the national shipment approval process within 20 days, which usually takes 2-3 months or more.