Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years

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.

Effectiveness of the BNT162b2 vaccine in preventing morbidity and mortality associated with COVID-19 in children aged 5 to 11 years: A systematic review and meta-analysis

“…Injection-site pain was the most common local reaction, with fatigue and headache being the most frequently reported systemic events [ 18 ]. This finding was also reported across the included observational studies [ 44 , 47 , 54 , 55 , 57 , 60 – 62 ]. The CDC passive vaccine safety surveillance system report identified serious adverse events such as seizures and myocarditis [ 44 ].…”

“…Of these, 16 investigated the safety, and effectiveness of two doses of the BNT162b2 vaccine compared to no vaccine/placebo in children aged 5 to 11 years [ 39 – 43 , 45 , 46 , 48 – 53 , 56 , 58 , 59 ]. The remaining eight studies were vaccine surveillance studies with no active comparator group [ 44 , 47 , 54 , 55 , 57 , 60 – 62 ]. The follow-up duration ranged from 14 to 90 days.…”

“…The CDC passive vaccine safety surveillance system report identified serious adverse events such as seizures and myocarditis [ 44 ]. Similarly, in the CVMS passive vaccine safety surveillance system used in South Korea [ 60 ] there was one reported case of suspected myocarditis/pericarditis and one suspected case of anaphylaxis following the first vaccine dose. These cases were not medically confirmed diagnoses.…”

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

“…The results of the first and second doses at 5-11 and 12-17 years were adapted from a previous study. 21) including the PF4 enzyme-linked immunosorbent assay antibody test, and the hematology advisory committee for COVID-19 vaccination reviewed all suspected cases and confirm ed diagnosis. As of June 4, 2022, 4 cases (3 males; 1 female) met the diagnostic criteria for TTS; all 4 cases were associated with AstraZeneca vaccine (0.2 cases per million AstraZeneca vaccine doses).…”

“…Systemic reactions included fever, chills, arthralgia, fatigue, nausea, vomiting, headache, myalgia, armpit pain, diarrhea, abdominal pain, and rashes. The results of the first and second doses at 5–11 and 12–17 years were adapted from a previous study [ 21 ].…”