Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea
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....
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
The Korean Pediatric Society
2023-10-01
|
| Series: | Clinical and Experimental Pediatrics |
| Subjects: | |
| Online Access: | http://www.e-cep.org/upload/pdf/cep-2022-00815.pdf |
| _version_ | 1827798480001695744 |
|---|---|
| author | Yeon-Kyeng Lee Yunhyung Kwon Yesul Heo Eun Kyoung Kim Seung Yun Kim Hoon Cho Seontae Kim Mijeong Ko Dosang Lim Soon-Young Seo Enhi Cho |
| author_facet | Yeon-Kyeng Lee Yunhyung Kwon Yesul Heo Eun Kyoung Kim Seung Yun Kim Hoon Cho Seontae Kim Mijeong Ko Dosang Lim Soon-Young Seo Enhi Cho |
| author_sort | Yeon-Kyeng Lee |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T19:37:17Z |
| format | Article |
| id | doaj.art-1aa82503279f4f90bbe2c25bf6953245 |
| institution | Directory Open Access Journal |
| issn | 2713-4148 |
| language | English |
| last_indexed | 2024-03-11T19:37:17Z |
| publishDate | 2023-10-01 |
| publisher | The Korean Pediatric Society |
| record_format | Article |
| series | Clinical and Experimental Pediatrics |
| spelling | doaj.art-1aa82503279f4f90bbe2c25bf69532452023-10-06T13:07:10ZengThe Korean Pediatric SocietyClinical and Experimental Pediatrics2713-41482023-10-01661041542310.3345/cep.2022.0081520125555616Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of KoreaYeon-Kyeng Lee0Yunhyung Kwon1Yesul Heo2Eun Kyoung Kim3Seung Yun Kim4Hoon Cho5Seontae Kim6Mijeong Ko7Dosang Lim8Soon-Young Seo9Enhi Cho10 Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Investigation Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Investigation Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, KoreaAs 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.http://www.e-cep.org/upload/pdf/cep-2022-00815.pdfcovid-19vaccinationsafetyadverse reactionspharmacovigilance |
| spellingShingle | Yeon-Kyeng Lee Yunhyung Kwon Yesul Heo Eun Kyoung Kim Seung Yun Kim Hoon Cho Seontae Kim Mijeong Ko Dosang Lim Soon-Young Seo Enhi Cho Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea Clinical and Experimental Pediatrics covid-19 vaccination safety adverse reactions pharmacovigilance |
| title | Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea |
| title_full | Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea |
| title_fullStr | Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea |
| title_full_unstemmed | Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea |
| title_short | Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea |
| title_sort | safety monitoring of covid 19 vaccines february 26 2021 to june 4 2022 republic of korea |
| topic | covid-19 vaccination safety adverse reactions pharmacovigilance |
| url | http://www.e-cep.org/upload/pdf/cep-2022-00815.pdf |
| work_keys_str_mv | AT yeonkyenglee safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT yunhyungkwon safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT yesulheo safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT eunkyoungkim safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT seungyunkim safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT hooncho safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT seontaekim safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT mijeongko safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT dosanglim safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT soonyoungseo safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea AT enhicho safetymonitoringofcovid19vaccinesfebruary262021tojune42022republicofkorea |