Active Surveillance for Safety Monitoring of XBB.1.5-Containing COVID-19 mRNA Vaccines in Korea

The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024....

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Published inJournal of Korean medical science Vol. 39; no. 43; pp. e309 - 7
Main Authors Park, Bomi, Lee, Hye Ah, Kim, Yeonjae, Kim, Chung Ho, Park, Hyunjin, Jun, Seunghee, Lee, Hyelim, Kwon, Seunghyun Lewis, Heo, Yesul, Lee, Hyungmin, Park, Hyesook
Format Journal Article
LanguageEnglish
Published The Korean Academy of Medical Sciences 11.11.2024
대한의학회
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Summary:The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024. This study demonstrates the adverse events reported through active nationwide surveillance after XBB.1.5 vaccination in Korea. Since October 19, 2023, the Korea Disease Control and Prevention Agency has conducted daily Short Message Service surveys to collect data on health issues, fever, vaccination site reactions, systemic symptoms, impact on daily life, and healthcare visits. Among 20,180 respondents, 27.9% reported health issues. Adverse reactions peaked on day 1 (28.7%), including pain at the vaccination site, muscle pain, fatigue, and fever. These findings elucidate the short-term safety of the XBB.1.5 vaccine and support its co-administration with the influenza vaccine, reducing vaccine hesitancy and achieving herd immunity.The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024. This study demonstrates the adverse events reported through active nationwide surveillance after XBB.1.5 vaccination in Korea. Since October 19, 2023, the Korea Disease Control and Prevention Agency has conducted daily Short Message Service surveys to collect data on health issues, fever, vaccination site reactions, systemic symptoms, impact on daily life, and healthcare visits. Among 20,180 respondents, 27.9% reported health issues. Adverse reactions peaked on day 1 (28.7%), including pain at the vaccination site, muscle pain, fatigue, and fever. These findings elucidate the short-term safety of the XBB.1.5 vaccine and support its co-administration with the influenza vaccine, reducing vaccine hesitancy and achieving herd immunity.
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These authors contributed equally to this work.
ISSN:1011-8934
1598-6357
1598-6357
DOI:10.3346/jkms.2024.39.e309