Ministry of Food and Drug Safety procedures… Advised external experts for’triple’
Results are disclosed on February 1 after the verification advisory group meeting
AstraZeneca’s Corona Vaccine will hold a’Corona Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as Verification Advisory Group) meeting with external experts on the 31st.
The verification advisory group meeting is a procedure for consulting external experts for objective and transparent approval review for corona treatment and vaccine. In this meeting, clinical experts focused on infectious medicine will participate to review the safety and effectiveness of the AstraZeneca vaccine, its clinical significance, and the appropriateness of the target patient.
As the AstraZeneca vaccine has recently been controversial about the efficacy of the 65-year-old elderly, the verification team is expected to put more weight on the verification. The results will be released on February 1. The Ministry of Food and Drug Safety is comparing and reviewing the vaccination group and the placebo group to see if there is any safety information that requires special attention from the elderly over 65 years of age.
The AstraZeneca vaccine applied for an item license from the Ministry of Food and Drug Safety on the 4th. This product is a vaccine that is administered twice in total, and the storage conditions are 2-8℃. It has signed a consignment production contract with SK Bioscience, a domestic vaccine company, and Korea has signed a purchase contract for about 10 million people.
On the 29th (local time), the European Union (EU) executive council approved the conditional sale of AstraZeneca’s corona vaccine. Following the vaccine developed by Pfizer and Modena, it is the third corona vaccine approved by the EU for conditional use.
The EU’s decision came a few hours after the European Medicines Agency (EMA) recommended conditional marketing approval for the vaccine to all age groups over 18 years of age. EMA said that the AstraZeneca vaccine was found to be safe and effective in preventing coronavirus in people over the age of 18, when the results of clinical trials conducted in the UK, Brazil and South Africa were combined.
Meanwhile, the Ministry of Food and Drug Safety is operating a national shipment approval system in which the country once again verifies the quality of vaccines.
National shipment approval is achieved by comprehensively evaluating the’assay test’ for each manufacturing unit (lot) for biological products such as vaccines and the’data review’ results (hereinafter referred to as data review) in which the manufacturer’s manufacturing and test results were submitted as permitted. This is a system in which the country once again checks the quality of products checked in the market before distribution.
In the verification test, a test to confirm the safety (sterility test, endotoxin test, etc.) and a test to confirm efficacy (potency test, confirmation test, etc.) are conducted considering the characteristics of each vaccine item, and if necessary, a protein content test and moisture content test. Additional tests, etc. are conducted.
The’Sterility Test’ and’Endotoxin Test’ to confirm the safety are used to check whether microorganisms such as bacteria are infected during the vaccine manufacturing process. It measures how much the genetic material expresses the antigenic protein in cells, and the’confirmation test’ checks whether the targeted genetic material or antigen is contained in the vaccine.
For example, for AstraZeneca vaccine, a total of 10 types such as potency test, confirmation test, and viral particle content test are scheduled, and for Pfizer vaccine, 12 types such as potency test, confirmation test, and lipid particle size test are scheduled as test items.
An official from the Ministry of Food and Drug Safety said, “The corona vaccine is made with a new manufacturing process that uses genetic materials such as virus vectors and mRNA, unlike conventional vaccines that used pathogens or antigen proteins, so a more thorough national shipment approval is required.” During the coronavirus pandemic, the vaccine will be designated as a target for rapid shipment approval, and will be treated prior to other medicines, and the national shipment approval will be shortened to within 20 days and the vaccine will be supplied to ensure safe vaccination.”
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