mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort study

作者：Phyumar Soe, Otto G. Vanderkooi, Manish Sadarangani, Monika Naus, Matthew Muller, James D. Kellner, Karina A. Top, Hubert Wong, Jennifer E. Isenor, Kimberly Marty, Hennady P. Shulha, Gaston De Serres, Louis Valiquette, Allison McGeer, Julie A. Bettinger · 发表于：The Lancet Regional Health - Americas · 年份：2024 · DOI：10.1016/j.lana.2024.100949 · 被引用次数：6 · 研究领域：SARS-CoV-2 and COVID-19 Research、Vaccine Coverage and Hesitancy、Kawasaki Disease and Coronary Complications

Background: The Canadian National Vaccine Safety Network conducted active safety surveillance for COVID-19 vaccines. This study aimed to characterize the short-to-medium term safety of mRNA COVID-19 vaccines across the pediatric age spectrum. Methods: In this cohort study, vaccinated and unvaccinated children and adolescents aged 6 months to 19 years from eight Canadian provinces and territories were invited to participate. The outcome was a health event preventing daily activities, resulting in school absenteeism, or requiring medical consultation. Age-stratified multivariable regression models were used to examine health events associated with first and second doses of mRNA COVID-19 vaccines across different age groups: children under 5, children aged 5-11 years and adolescents aged 12-19 years. Findings: From January 2021 through February 2023, a total of 259,361 individuals from the dose one survey, 131,032 from the dose 2 survey, and 1179 from the control survey were included. In the week following dose two, vaccinated adolescents showed a higher proportion of health events [794 (4.6%) of 17,218 BNT162b2 recipients, 98 (8.5%) of 1153 mRNA-1273 recipients, 49 of (10.6%) of 464 heterologous schedule recipients] than unvaccinated adolescents [9 (3.7%) of 242 controls], but most events were self-limited and resolved within 7 days. No significant differences in proportion of health events following mRNA COVID-19 vaccines were observed between vaccinated and unvaccinated group...