The Ministry of Food and Drug Safety has approved the AstraZeneca vaccine for the first time as a COVID-19 vaccine.



Vaccination targets are adults over the age of 18, including those over 65.



The Ministry of Food and Drug Safety announced the results of the final inspection committee meeting, in which three outside experts and five members of the Ministry of Food and Drug Safety, including KFDA chief Kim Kang-rip, attended from 10 am on the 10th.



As a result of the meeting, the Ministry of Food and Drug Safety granted permission for all age groups on the condition that AstraZeneca submits the results of phase 3 clinical trials in the United States, in addition to the previously submitted clinical data.



The adverse events reported were mostly predicted related to vaccination and were judged to be overall good.



No serious abnormalities occurred even in elderly people 65 years of age or older.



As a result of analyzing the effectiveness of two clinical trials including phase 2 and 3 clinical trials in the UK and Phase 3 clinical trials in Brazil, the preventive effect was found to be 62%.



However, it was decided to write in the'Precautions for use' that'the use for the elderly over the age of 65 must be carefully decided'.



Even for the elderly, there is no problem in terms of safety and immune response, but this is because 7.4% of the elderly clinical participants to confirm the preventive effect are insufficient.



This means that the doctor should determine the benefits of vaccination based on the person's condition.



This meeting is the final step of consulting an external expert'triple' by the Ministry of Food and Drug Safety during the approval process of the Corona 19 vaccine and treatment.



At the first stage verification advisory group, many opinions suggested that elderly people 65 years of age or older could also get the AstraZeneca vaccine.



However, the 2nd Stage Central Pharmacist Review Committee gave permission to all age groups over the age of 18, but suggested that the vaccination committee of the Korea Centers for Disease Control and Prevention (KCDC) discuss whether vaccinations should be inoculated for the elderly over the age of 18.



AstraZeneca Vaccine is a viral vector vaccine that puts the corona 19 virus surface antigen gene into an adenovirus that only infects chimpanzees, is cultured, and delivered into human cells.



The delivered COVID-19 antigen gene synthesizes the antigen protein in the body and induces the production of neutralizing antibodies.



0.5ml each is administered by intramuscular injection twice within 4-12 weeks.



This vaccine is manufactured by AstraZeneca by consigning it to SK Bioscience in Korea.



AstraZeneca vaccine has received conditional approval or emergency use approval from 50 countries, including the European Medicines Agency (EMA) and the UK, but apart from the licensing requirements, some European countries have recommended that AstraZeneca vaccine not be given to the elderly.



Switzerland, which is a European country but not the European Union, has withheld approval for all-ages vaccinations.