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KMID : 1161220230660100415
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Clinical and Experimental Pediatrics
2023 Volume.66 No. 10 p.415 ~ p.423
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Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea
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Lee Yeon-Kyeng
Kim Hyung-Il
Heo Ye-Sul
Kim Eun-Kyoung
Park Keun-Gyu
Cho Hoon
Kim Seon-Tae
Ko Mi-Jeong
Lim Do-Sang
Seo Soon-Young
Oh Ji-Hoon
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Abstract
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As of June 2022, 5 coronavirus disease 2019 (COVID-19)vaccine brands have been used in Korea’s national immunization program. The Korea Disease Control and PreventionAgency has enhanced vaccine safety monitoring through apassive web-based reporting system and active text messagebased monitoring. In this study, an enhanced safety monitoring system for COVID-19 vaccines is described and the frequencies and types of adverse events (AEs) associated with the5 COVID-19 vaccine brands were analyzed. AE reports fromthe web-based COVID-19 Vaccination Management Systemand text message-based reports from recipients were analyzed.
AEs were classified as nonserious or serious (e.g., death oranaphylaxis). The AE reporting rates were calculated basedon the number of COVID-19 vaccine doses administered. Atotal of 125,107,883 doses were administered in Korea fromFebruary 26, 2021, to June 4, 2022. Among them, 471,068AEs were reported, of which 96.1% were nonserious and3.9% were serious. Among the 72,609 participants in thetext message-based AE monitoring process, a higher AErate of local and systemic reactions was reported for the 3rdversus 1st doses. A total of 874 cases of anaphylaxis (7.0 per1,000,000 doses), 4 cases of thrombocytopenia syndrome(TTS), 511 cases of myocarditis (4.1 per 1,000,000 doses),and 210 cases of pericarditis (1.7 per 1,000,000 doses)were confirmed. Six fatalities were causally associated withCOVID-19 vaccination (1 of TTS and 5 of myocarditis).
Young adult age and female sex were related with a higherAE rate for COVID-19 vaccines. Most reported AEs werenonserious and of mild intensity.
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KEYWORD
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COVID-19, Vaccination, Safety, Adverse reactions, Pharmacovigilance
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