
The Ministry of Food and Drug Safety announced at the end of this month that it has approved the national shipment of 787,000 AstraZeneca vaccines, the national corona 19 vaccination target, on the 17th.
The Ministry of Food and Drug Safety announced on the 29th of last month that it would shorten the national shipment approval of drugs, which usually takes 2-3 months, to within 20 days for the Corona 19 vaccine so that there is no disruption in the national vaccination plan. Korea AstraZeneca applied for the national shipment approval of the vaccine stock.
This AstraZeneca vaccine quantity is a product commissioned by SK Bioscience. This became the first nationally approved vaccine in Korea.
National shipment approval is a system that checks the quality of medicines once more before they are distributed to the market. Unlike conventional vaccines that used pathogens or antigenic proteins, the Corona 19 vaccine is made by a new manufacturing process that uses genetic materials such as virus vectors and mRNA, so more thorough national shipment approval is required.
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In the verification test according to the institutional procedure, it is confirmed that there is no microbial contamination related to safety, and the content test is measured regarding effectiveness. Through the review of the data, it was confirmed that it conforms to the drug manufacturing and quality control standards (GMP) and approved items.
According to the government’s COVID-19 vaccination plan from February to March, the AstraZeneca vaccine will be vaccinated to residents and workers in nursing and rehabilitation facilities under the age of 65 from the 26th.