Approval of conditions for submission of additional clinical trial results
Vaccinations over 65 are left to the doctor’s judgment
Dose 0.5ml·2 times every 4~12 weeks
Vaccination priority will be finalized next week
Minister of Food and Drug Safety Kim Kang-rip explains that the AstraZeneca vaccine approval was finalized as a result of a meeting of the Final Inspection Committee to verify the effectiveness and safety of the Corona 19 vaccine in a conference room of the Ministry of Food and Drug Safety in Cheongju, Chungbuk on the afternoon of the 10th. Cheongju/Yonhap News
AstraZeneca’s COVID-19 vaccine was the first in Korea to obtain approval from the Ministry of Food and Drug Safety. Although there was a controversy over the lack of the number of clinical trials in the elderly, the Ministry of Food and Drug Safety decided to approve the product with the content that it can be used by all age groups over 18. The priorities of vaccination, such as whether or not to be vaccinated for the elderly, will be finalized after a deliberation by the Vaccination Committee of the Korea Centers for Disease Control and Prevention next week. The Ministry of Food and Drug Safety held a final inspection committee on the 10th to verify the effectiveness and safety of the Corona 19 vaccine prior to approval, and additional clinical trials for the Corona 19 vaccine’Korea AstraZenecacovid-19 vaccine’, which AstraZeneca Korea Co., Ltd. applied for approval on the 4th of last month. It said that the approval was decided on the condition of submitting test results, etc. Kim Kang-rip, head of the Food and Drug Administration, explained at a briefing on the day that “a condition was imposed to submit the results of clinical trials in the United States for a total of 30,000 people, including about 7500 elderly people, by the end of April this year.” The final inspection committee reviewed the contents of the previous two expert consultations (the verification advisory group on Jan. 31, and the central pharmacist review committee on Feb. 4), and respected the advisory opinions of the central pharmacist review committee. The vaccine was licensed to’over 18′. However, after accepting the recommendations of the Central Pharmacy Deliberation Committee, it was finally decided to write in the’Precautions for use’ that “the use for the elderly over the age of 65 should be carefully decided.” There is no problem in terms of safety and immune response to the elderly, but additional data are needed to determine the preventive effect, so it means that the doctor should determine the benefit of vaccination according to the subject’s condition.
Reuters Yonhap News
“We conclude that permission is a prerequisite for the use of the vaccine, and that we have not found a reason to grant permission by limiting vaccinations over 65 years of age.” Yoo-hwan, chairman of the Central Pharmacist Review and Hygiene Subcommittee, explained, “The risk of Corona 19 infection and our socio-economic needs (for vaccines) should be considered complex in the clinical field.” In addition to Chairman Oh, three outside experts and five insiders, including the head of the Food and Drug Administration, attended the final inspection committee meeting. The vaccine administration dose and administration interval were finally determined by taking the standard dose (0.5 ml) twice every 4 to 12 weeks. Vaccination is not recommended for pregnant or lactating people. The Agency for Disease Control and Prevention plans to finalize the list of vaccination targets by the 19th after a deliberation by the Vaccination Specialist Committee to determine the order and target of the AstraZeneca vaccine vaccination plan. If the Agency for Disease Control concludes’Vaccination to the Elderly’, the vaccine made by SK Bioscience at the Andong plant in Gyeongbuk will be inoculated to nursing hospitals and nursing facility residents and workers from the 26th. From this month, the Central Defense Response Headquarters (Bang Dae-bon) announced that it will designate the National Medical Center and three regional infectious disease hospitals (Suncheonhyang University Cheonan Hospital, Chosun University Hospital, and Yangsan Pusan National University Hospital) as the central and regional vaccination centers for COVID-19. Of the 250 local vaccination centers to be installed in cities, counties, and gus nationwide, 18 (1 by city/province, 2 in Gyeonggi-do) will be installed first in next month, and the remaining 232 will be installed after July. By Choi Ha-yan, staff reporter [email protected]