AstraZeneca Vaccine License,’Vaccination Timetable’ in Operation from the 26th

The Ministry of Food and Drug Safety approved the domestic distribution of the AstraZeneca vaccine on the 10th. Elderly people over the age of 65 were also included in the vaccination.

AstraZeneca vaccine will be vaccinated in Korea from the 26th. The vaccine produced at SK Bioscience’s Andong plant in Gyeongbuk is used in Korea. Accordingly, the AstraZeneca vaccine became the first Corona 19 vaccine approved by the Korean government.

The Ministry of Food and Drug Safety decided this by holding a final inspection committee at 10 am on the same day. In order to increase the expertise and objectivity of the review process, the Ministry of Food and Drug Safety decided to approve the AstraZeneca vaccine on the same day through a triple consultation procedure of the Verification Advisory Group, the Central Pharmacy Review Committee, and the Final Inspection Committee.

AstraZeneca vaccine is a virus vector-based vaccine that is cultured and produced by putting the corona19 virus surface antigen gene into an adenovirus that only infects chimpanzees, and then delivering it into human cells. The delivered corona antigen gene synthesizes antigen proteins in the body to induce the production of neutralizing antibodies, and when the corona 19 virus enters the human body, it removes the virus.

Vaccination subjects are 18 years of age or older, and 0.5 ml per vaccination is administered twice within a period of 4 to 12 weeks.

In the case of pregnant and lactating women, vaccination is possible if the significance of the vaccine is judged to exceed the risk, but as a precautionary measure, vaccination of the AstraZeneca vaccine during pregnancy is not recommended.

For nursing mothers, the phrase’it is impossible to know if this drug is secreted into breast milk’ was posted in the precautions for use.

The AstraZeneca vaccine to be distributed in Korea is a product consigned to SK Bioscience by AstraZeneca of Korea. Earlier, the AstraZeneca vaccine received conditional approval or emergency use approval from 50 governments around the world, including the European Medicines Agency (EMA).

Earlier, on the 4th of last month, the Ministry of Food and Drug Safety (KFDA) received an application for product permission for the AstraZeneca vaccine, and then formed a dedicated evaluation team for the approval of the Corona 19 vaccine to intensively review the relevant contents.

On that day, the final inspection committee judged that the safety of the AstraZeneca vaccine was good. Previously, the safety evaluation of the AstraZeneca vaccine was conducted in the UK, Brazil, and South Africa four times in a total of 2,3745 subjects over the age of 18.

Very common abnormal cases were injection site pain and fever, and symptoms were mild to moderate. Symptoms disappeared within a few days after vaccination.

There were no abnormal cases such as anaphylactic reaction and worsening corona symptoms.

There were no serious abnormalities even in the elderly over the age of 65. The incidence of cases over 65 years of age was similar or lower than that of the adult population.

However, an opinion was raised that monitoring is necessary after permission for the occurrence of nervous system-related abnormalities including transverse myelitis, and the Ministry of Food and Drug Safety decided to additionally reflect the abnormal cases reported in the future to the license matters.

The effectiveness evaluation was conducted twice in the UK and Brazil, targeting 8895 people over the age of 18 who were negative for Corona 19.

As a result of the evaluation, 27 corona19 confirmed cases in the vaccine group and 71 cases in the control group occurred, respectively, showing 62% of the preventive effect. This was evaluated as a result that satisfies the vaccine effectiveness criteria proposed by the World Health Organization (WHO).

However, the Ministry of Food and Drug Safety added a statement stating that’the use of the aged 65 or older should be carefully determined’ to the precautions for use based on the fact that sufficient data to prove the effect on the elderly have not been accumulated I decided to do it.

About 660 clinical participants over 65 years of age who participated in the evaluation of AstraZeneca vaccine effectiveness.

Accordingly, all preliminary procedures for domestic vaccination of the AstraZeneca vaccine were completed.

Earlier, the Korea Centers for Disease Control and Prevention announced on the 9th that “Vaccines will be delivered to inoculation institutions such as public health centers from the 25th and vaccinations will start sequentially from the 26th.”

To this end, 750,000 doses (1.5 million doses) of the AstraZeneca vaccine will be supplied sequentially from the 24th.

AstraZeneca vaccine can be stored and distributed in a refrigerator (2 to 8 degrees Celsius), so unlike Pfizer, Moder, and vaccines, a separate vaccination system is not required.

The AstraZeneca vaccine, which will be vaccinated this month, is part of the 10 million vaccine that the government has signed an individual contract with AstraZeneca.

As the Ministry of Food and Drug Safety finalizes the approval of the AstraZeneca vaccine item, the Agency for Disease Control and Prevention will adjust the detailed vaccination plan by the 19th to announce the confirmation of the first vaccination target.