Safety check such as sterility test by the Ministry of Food and Drug “The elderly should be cautious” recommendation
As the AstraZeneca (AZ) vaccine passed the national shipment approval process of the health authorities, the final quality test phase was completed.
On the 17th, the Ministry of Food and Drug Safety announced that AstraZeneca’s COVID-19 vaccine would be approved for shipment to the country for 787,000 people (1574,000 doses).
National shipment approval means that the quality of the vaccine is evaluated by the state once before distribution to the market by comprehensively evaluating the results of the’testing test’ for each vaccine manufacturing unit and the’data review’ of manufacturing and submitting the test results as authorized by the manufacturer. It is a system to confirm more.
AstraZeneca’s Corona 19 vaccine has entered the national shipment approval process after obtaining product approval from the Ministry of Food and Drug Safety on the 10th.
Normally, it takes about 2 to 3 months for national shipment approval, but the Ministry of Food and Drug Safety designated the Corona 19 vaccine as a subject for rapid shipment approval and completed the procedure in 20 days.
The Ministry of Food and Drug Safety confirmed the safety through sterility tests, etc., and the effectiveness by measuring the amount of protein expression that indicates the effect of the vaccine.
The vaccine that has been approved for shipment this time is a quantity manufactured by entrusting all processes by SK Bioscience, and is used for the first domestic Corona 19 vaccine vaccination that will be implemented on the 26th.
The Ministry of Food and Drug Safety has allowed the vaccine to be used by all adults over the age of 18.
However, there was a condition that the administration to the elderly over the age of 65 must be carefully determined.
Although there is no problem with safety, it is based on the judgment that there is still insufficient evidence to determine the preventive effect for the elderly.
In this regard, the government plans to give the AstraZeneca vaccine first to those under the age of 65 for the time being.
For the elderly, clinical information related to the preventive effect of this vaccine will be additionally checked, and the use of this vaccine will be confirmed after deliberation by the Vaccination Specialist Committee.
Meanwhile, the Ministry of Food and Drug Safety is also speeding up the screening for approval of Pfizer’s COVID-19 vaccine.
On the 25th of last month, Pfizer applied for an item permission for the Corona 19 vaccine with the Ministry of Food and Drug Safety. It is separate from the Pfizer vaccine of COVAX facility, which was recently approved for special import.
After the fourth week of this month, the Ministry of Food and Drug Safety will conduct a’triple’ expert consultation procedure on Pfizer’s Corona 19 vaccine. If it is as planned, it is expected to obtain permission after the first week of March.
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