Objectives: This study aimed to disseminate information on coronavirus disease 2019 (COVID-19) vaccine safety among adolescents aged 12 to 17 years in the Republic of Korea.Methods: Two databases were used to assess COVID-19 vaccine safety in adolescents aged 12 to 17 years who completed the primary Pfizer-BioNTech vaccination series. Adverse events reported to the web-based COVID-19 vaccination management system (CVMS) and collected in the text message-based system were analyzed.Results: From March 5, 2021 to February 13, 2022, 12,216 adverse events among 12- to 17-year-olds were reported to theCVMS, of which 97.1% were non-serious adverse events and 2.9% were serious adverse events, including 85 suspected cases of anaphylaxis, 74 suspected cases of myocarditis and/or pericarditis, and 2 deaths. From December 13, 2021 to January 26, 2022, 10,389 adolescents responded to a text message survey, and local/systemic adverse events were more common after dose 2 than after dose 1. The most commonly reported events following either vaccine dose were pain at the injection site, headache, fatigue/tiredness, and myalgia.Conclusion: The overall results are consistent with safety data reported in the United States and a controlled trial and serious adverse.events were rare among adolescents aged 12 to 17 years following COVID-19 vaccination.
Objectives: This study aimed to identify potential safety signals and adverse events following the primary Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccination series among children and adolescents aged 5 to 17 years in the Republic of Korea.Methods: Adverse events reported through the COVID-19 vaccination management system (CVMS, a web-based passive vaccine safety surveillance system) and adverse events and health conditions collected from a text message-based survey were analyzed.Results: A total of 14,786 adverse events among 5- to 17-year-old children and adolescents were reported in the CVMS; 14,334 (96.9%) were non-serious and 452 (3.1%) were serious, including 125 suspected cases of acute cardiovascular injury and 101 suspected cases of anaphylaxis. The overall reporting rate was lower in 5- to 11-year-old children (64.5 per 100,000 doses) than in 12- to 17-year-old adolescents (300.5 per 100,000 doses). The text message survey identified that local and systemic adverse events after either dose were reported less frequently in 5- to 11-year-old children than in 12- to 17-year-old adolescents (p<0.001). The most commonly reported adverse events were pain at the injection site, myalgia, headache, and fatigue/tiredness.Conclusion: The overall results are consistent with the results of controlled trials; serious adverse events were extremely rare among 5- to 17-year-old children and adolescents following Pfizer-BioNTech COVID-19 vaccination. Adverse events were less frequent in children aged 5 to 11 years than in adolescents aged 12 to 17 years.
Objectives: The household secondary attack rate (SAR) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important indicator for community transmission. This study aimed to characterize transmission by comparing household SARs and identifying risk factors during the periods of Delta and Omicron variant predominance in Republic of Korea.Methods: We defined the period of Delta variant predominance (Delta period) as July 25, 2021 to January 15, 2022, and the period of Omicron variant predominance (Omicron period) as February 7 to September 3, 2022. The number of index cases included was 214,229 for the Delta period and 5,521,393 for the Omicron period. To identify the household SARs and risk factors for each period, logistic regression was performed to determine the adjusted odds ratio (aOR).Results: The SAR was 35.2% for the Delta period and 43.1% for the Omicron period. The aOR of infection was higher in 2 groups, those aged 0 to 18 years and ≥75 years, compared to those aged 19 to 49 years. Unvaccinated individuals (vs. vaccinated individuals) and individuals experiencing initial infection (vs. individuals experiencing a second or third infection) had an increased risk of infection with SARS-CoV-2.Conclusion: This study analyzed the household SARs and risk factors. We hope that the results can help develop age-specific immunization plans and responses to reduce the SAR in preparation for emerging infectious diseases or potential new variants of SARS-CoV-2.
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