의약품부작용보고원시자료(KAERS DB)를 이용한 인플루엔자 백신 대비 코로나19 백신 실마리정보 분석

• 영문명: Signal Analysis of COVID-19 Vaccine compared to Influenza Vaccine using KAERS Database
• 발행기관: 대한약학회
• 저자명: 고하나(Hana Go) 박수빈(Suvin Park) 임은선(Eunsun Lim) 이희언(Hui-Eon Lee) 조해린(Haerin Cho) 최남경(Nam-Kyong Choi)
• 간행물 정보: 『약학회지』제68권 제6호(2024년), 471~478쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2024.12.31

국문 초록

Safety issues have arisen as vaccines have been rapidly vaccinated following a relatively short clinical trial period to prevent COVID-19 infection. In signal detection, based on disproportionality analysis, it is necessary to select an appropriate comparator because the results vary depending on the comparison group. To detect meaningful signals, we compared COVID-19 vaccines with Influenza vaccines, which targets respiratory diseases similarly and has well-known safety profile. We used adverse events of vaccines from Korea Adverse Event Reporting System Database between January 1, 2013, and December 31, 2022(2307A0006). We detected the signal that satisfied all three indices: Proportional reporting ratio, Reporting odds ratio and Information component and detected signals were compared with the drug label in Korea, United States and Europe. A total of 15 signals of Headache, Dizziness, Nausea, Hypersensitivity, Chills, Chest pain, Injection site erythema, Urticaria, Vomiting, Rash, Abdominal pain, Diarrhoea, Lymphadenitis, Cellulitis and Generalized oedema were detected. Among these, Lymphadenitis, Cellulitis and Generalized oedema were not listed on drug label. The results in this study are expected to contribute to assess the safety of COVID-19 vaccines and wellcontrolled studies are required to determine the causal relationship between COVID-19 vaccines and the detected signal.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

Conflict of Interest

References

키워드

COVID-19 Vaccine Adverse event Signal detection KAERS Database

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