[의학신문·일간보사=정민준 기자]The Ministry of Food and Drug Safety (Director Kang-Rip Kim) approved the national shipment of 787,000 Korean AstraZenecacovid-19 vaccine stocks applied by AstraZeneca Korea on Jan. .
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| Astra Corona 19 Vaccine |
This approval was carried out quickly within 20 days of national shipment approval, which usually takes 2 to 3 months, and will be used for the first domestic corona 19 vaccine vaccination by the Korea Centers for Disease Control and Prevention. In January, the Corona 19 vaccine was designated as a target for rapid shipment approval in order to ensure that the quantity needed during the corona 19 pandemic was supplied in a timely manner, and △ prioritized shipment approval to other countries.
The’Korea AstraZenecacovid-19 vaccine’, which is approved for shipment this time, is a quantity manufactured by consigning all processes from SK Bioscience. And prepared a test method.
In addition, in preparation for the concentration of applications for national shipment approval of the Corona 19 vaccine, the sample storage room was expanded and additional storage freezers were secured.
The Ministry of Food and Drug Safety confirmed the safety and effectiveness of each manufacturing unit through a verification test of 1574,000 batches and a review of data on manufacturing and testing for national shipment approval. We decided to approve shipment.
‘Korea AstraZenecacovid-19 Vaccine’ is a viral vector vaccine that performs aseptic tests related to safety and endotoxin tests to confirm that there is no contamination of microorganisms such as bacteria during the manufacturing process of the vaccine, and efficacy and related potency tests, confirmation tests, and virus vectors Content tests, etc. were conducted to measure the amount of protein expression showing the effect, the maintenance of the desired genetic material, and the amount of the vector, which is a genetic material carrier.
An official from the Ministry of Food and Drug Safety said, “We will do our best to ensure that the Korean people can receive the vaccine with confidence by thoroughly verifying the Corona 19 vaccine introduced in Korea by making full use of the relevant infrastructure such as experts and equipment required for national shipment approval.” said.