Ministry of Food and Drug Safety, final decision on the 10th…the first case of COVID-19 vaccine approval in Korea
Including controversial ’65 years of age or older’…
The Ministry of Food and Drug Safety has decided to approve the AstraZeneca Corona 19 vaccine. This is the first case of corona 19 vaccine approval in Korea.
The controversial’elderly people over 65′ decided to include it in the subject of permission in order to write in the usage precautions that the use should be carefully decided.
The Ministry of Food and Drug Safety explained that there was no reason to impose age restrictions from the approval stage, based on various evidences. In fact, it is expected that confusion is expected because it has left the judgment on whether or not to inoculate the elderly in the clinical field.
The Ministry of Food and Drug Safety held a final inspection committee consisting of internal and external experts today on the 10th, and the results of additional clinical trials for the’Korea AstraZenecacovid-19 vaccine’ that AstraZeneca Korea applied for permission on January 4, etc. “I decided to grant permission as a condition to submit it.”
In addition to the previously submitted clinical data, it means that the product is approved under the condition of submitting the results of phase 3 clinical trials in progress in the United States after approval. The AstraZeneca vaccine has received such conditional approval or emergency use approval in 50 countries including Europe and the UK.
AstraZeneca vaccine is a virus vector vaccine that is cultured and produced by putting the corona 19 virus surface antigen gene into an’adenovirus’ that only infects chimpanzees, and then delivering it into human cells.It neutralizes and removes the virus when the corona 19 virus enters the human body. It works.
The efficacy and effect of the drug is the prevention of Corona 19 in adults over 18 years, including those over 65 years old, and is used by intramuscular injection of 0.5 mL twice within 4-12 weeks.
It was concluded that the controversial part of the permission for the elderly was included in the end. In the precautions for use, it is stated that’the use for the elderly over the age of 65 must be carefully decided’.
The Ministry of Food and Drug Safety said, “There is no problem in terms of safety and immune response to the elderly over 65 years old, but there are 660 (7.4%) elderly clinical participants to confirm the preventive effect, and additional data are needed to verify statistically. It means to judge and determine the benefits of vaccination according to the subject’s condition.”
In fact, the situation is expected to be confused because it has left the judgment of the elderly to be vaccinated on the clinical site.
In response, the Ministry of Food and Drug Safety said, “Permission is a prerequisite for drug use, and satisfying the sufficient conditions for whether or not it will be used in the field is achieved when the judgment of the medical staff is combined in the clinical field.” “Our conclusion is that we have not found a reason to limit vaccination for the elderly from the approval stage.”
“When using the vaccine, we will fully consider various considerations and make judgments in the clinical field.” “The Centers for Disease Control and Prevention is listening to the opinions of experts in this regard, and reasonable and appropriate guidelines will be presented through discussions by the Vaccination Committee in the future. I look forward to it.”
In the case of pregnant women, vaccination was not recommended. If the benefit of using the vaccine exceeds the risk, it may be used, but it is judged that it is not recommended to vaccinate this vaccine during pregnancy as a preventive measure. For nursing mothers, “It is unknown if this drug is secreted into breast milk” in the precautions for use.
The Ministry of Food and Drug Safety said, “It was the first time in Korea to approve the Corona 19 vaccine by thoroughly verifying the safety and effectiveness,” and “cooperated with relevant ministries to strengthen the surveillance system for abnormal cases after vaccination and to quickly respond to abnormal cases through thorough monitoring. We will do our best so that the vaccine can be safely used by the public.”
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