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

Signal Analysis of COVID-19 Vaccine compared to Influenza Vaccine using KAERS Database

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.