tetano
Editor, Senior Moderator
Osong Public Health Res Perspect
. 2022 Oct;13(5):382-390.
doi: 10.24171/j.phrp.2022.0233. Epub 2022 Oct 14.
Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years
Seontae Kim[SUP] 1 [/SUP], Yeseul Heo[SUP] 1 [/SUP], Soon-Young Seo[SUP] 1 [/SUP], Do Sang Lim[SUP] 1 [/SUP], Enhi Cho[SUP] 2 [/SUP], Yeon-Kyeng Lee[SUP] 1 [/SUP]
Affiliations
Abstract
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.
Keywords: Adolescent; COVID-19; Child; Safety; Vaccination; Vaccines.
. 2022 Oct;13(5):382-390.
doi: 10.24171/j.phrp.2022.0233. Epub 2022 Oct 14.
Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years
Seontae Kim[SUP] 1 [/SUP], Yeseul Heo[SUP] 1 [/SUP], Soon-Young Seo[SUP] 1 [/SUP], Do Sang Lim[SUP] 1 [/SUP], Enhi Cho[SUP] 2 [/SUP], Yeon-Kyeng Lee[SUP] 1 [/SUP]
Affiliations
- PMID: 36328243
- DOI: 10.24171/j.phrp.2022.0233
Abstract
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.
Keywords: Adolescent; COVID-19; Child; Safety; Vaccination; Vaccines.