Clin Exp Pediatr.  2023 Oct;66(10):415-423. 10.3345/cep.2022.00815.

Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea

• Lee YK
• Kwon Y
• Heo Y
• Kim EK
• Kim SY
• Cho H
• Kim S
• Ko M
• Lim D
• Seo SY
• Cho E

• KMID: 2546365
• DOI: http://doi.org/10.3345/cep.2022.00815

Abstract

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 Prevention Agency has enhanced vaccine safety monitoring through a passive web-based reporting system and active text message-based 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 the 5 COVID-19 vaccine brands were analyzed. AE reports from the web-based COVID-19 Vaccination Management System and text message-based reports from recipients were analyzed. AEs were classified as nonserious or serious (e.g., death or anaphylaxis). The AE reporting rates were calculated based on the number of COVID-19 vaccine doses administered. A total of 125,107,883 doses were administered in Korea from February 26, 2021, to June 4, 2022. Among them, 471,068 AEs were reported, of which 96.1% were nonserious and 3.9% were serious. Among the 72,609 participants in the text message-based AE monitoring process, a higher AE rate of local and systemic reactions was reported for the 3rd versus 1st doses. A total of 874 cases of anaphylaxis (7.0 per 1,000,000 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 with COVID-19 vaccination (1 of TTS and 5 of myocarditis). Young adult age and female sex were related with a higher AE rate for COVID-19 vaccines. Most reported AEs were nonserious and of mild intensity.

Keyword

COVID-19; Vaccination; Safety; Adverse reactions; Pharmacovigilance