The Ministry of Food and Drug Safety announced on the 17th that the vaccine for 787,000 people applied by AstraZeneca Korea was approved for shipment by the country on the 17th.
This approval was carried out quickly in 20 days for national shipment approval, which usually takes 2-3 months.
The Ministry of Food and Drug Safety explained that the AstraZeneca vaccine will be used for the first corona 19 vaccine vaccination, and has prioritized other national shipment approvals so that the necessary quantities can be supplied during the pandemic.
The AstraZeneca vaccine, which was approved for shipment, was manufactured by consigning all processes from SK Bioscience, and a detailed test method was submitted to the manufacturer in August of last year to prepare a test method.
In addition, the sample storage room was expanded and additional storage freezers were secured in preparation for the concentration of applications for national shipment approval of the Corona 19 vaccine.
The Ministry of Food and Drug Safety confirmed the safety and effectiveness of each manufacturing unit through a verification test and a review of data on manufacturing and testing for 1574,000 batches.
As for the test, sterility test and endotoxin test were conducted to confirm that there was no microbial contamination during the manufacturing process.
Regarding the effectiveness, the amount of protein expression, the maintenance of the desired genetic material, and the amount of the genetic material carrier vector were measured through potency tests, confirmation tests, and viral vector content tests.
In addition, properties test, pH measurement test, and effective dose test of injections were conducted as general vaccine quality test items.
The Ministry of Food and Drug Safety explained that the results of reviewing detailed information and manufacturing and quality control records related to vaccine raw materials, semi-finished products, and finished drugs were suitable for pharmaceutical manufacturing and quality control standards.
Including information on the proliferation history of cell lines and viral lines used as vaccine materials, manufacturing and storage information, test methods, test standards and results were confirmed at each stage of the manufacturing process.
An official from the Ministry of Food and Drug Safety said, “We will thoroughly verify the corona vaccine introduced in Korea by maximizing the relevant infrastructure such as professional manpower and equipment required for national shipment approval.” Ⓒ Safe Times
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