mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in context
Summary: 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 u...
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Elsevier
2024-12-01
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| Series: | The Lancet Regional Health. Americas |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667193X2400276X |
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| author | Phyumar Soe Otto G. Vanderkooi Manish Sadarangani Monika Naus Matthew P. 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 |
| author_facet | Phyumar Soe Otto G. Vanderkooi Manish Sadarangani Monika Naus Matthew P. 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 |
| author_sort | Phyumar Soe |
| collection | DOAJ |
| description | Summary: 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 groups among adolescents after dose 1, or among children under 5 or those aged 5–11 years after any dose. Reported myocarditis/pericarditis cases within 0–28 days peaked among male adolescents following dose 2, in three of (0.037%) 8088 homologous BNT162b2 recipients, and two of (0.529%) 378 homologous mRNA-1273 recipients. Interpretation: Our findings suggest that reported health events, including myocarditis/pericarditis, vary by pediatric age group. Vaccinated adolescents reported health events more frequently following the second mRNA COVID-19 vaccine dose, while younger age groups did not report events more frequently than their unvaccinated counterparts. Funding: Canadian Immunization Research Network, Canadian Institutes of Health Research; Public Health Agency of Canada; COVID-19 Immunity Task Force. |
| format | Article |
| id | doaj-art-0243646eaa7b43f5af98929d0a4bc9cf |
| institution | OA Journals |
| issn | 2667-193X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
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| series | The Lancet Regional Health. Americas |
| spelling | doaj-art-0243646eaa7b43f5af98929d0a4bc9cf2025-08-20T02:06:57ZengElsevierThe Lancet Regional Health. Americas2667-193X2024-12-014010094910.1016/j.lana.2024.100949mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in contextPhyumar Soe0Otto G. Vanderkooi1Manish Sadarangani2Monika Naus3Matthew P. Muller4James D. Kellner5Karina A. Top6Hubert Wong7Jennifer E. Isenor8Kimberly Marty9Hennady P. Shulha10Gaston De Serres11Louis Valiquette12Allison McGeer13Julie A. Bettinger14Vaccine Evaluation Center, BC Children’s Hospital Research Institute, Vancouver, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, CanadaDepartment of Pediatrics and Alberta Children’s Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada; Corresponding author. Department of Pediatrics and Alberta Children’s Hospital Research Institute, University of Calgary, Alberta Children’s Hospital, 28 Oki Drive NW, Calgary AB T3B 6A8, Canada.Vaccine Evaluation Center, BC Children’s Hospital Research Institute, Vancouver, British Columbia, Canada; Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, CanadaSchool of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; BC Center for Disease Control, Vancouver, British Columbia, CanadaDepartment of Medicine, Unity Health Toronto, Toronto, Ontario, CanadaDepartment of Pediatrics and Alberta Children’s Hospital Research Institute, University of Calgary, Calgary, Alberta, CanadaCanadian Center for Vaccinology, IWK Health and Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, CanadaSchool of Population and Public Health, University of British Columbia, Vancouver, British Columbia, CanadaCanadian Center for Vaccinology, IWK Health and Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, CanadaVaccine Evaluation Center, BC Children’s Hospital Research Institute, Vancouver, British Columbia, CanadaVaccine Evaluation Center, BC Children’s Hospital Research Institute, Vancouver, British Columbia, Canada; Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, CanadaCHU de Québec-Université Laval, Québec City, Québec, Canada; Institut National de Santé Publique Du Québec, Québec City, Québec, CanadaDepartment of Microbiology and Infectious Diseases, Université de Sherbrooke, Sherbrooke, Quebec, CanadaDepartment of Microbiology, Sinai Health System, Toronto, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, CanadaVaccine Evaluation Center, BC Children’s Hospital Research Institute, Vancouver, British Columbia, Canada; Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada; Corresponding author. Department of Pediatrics, University of British Columbia, 950 West 28th Avenue, Vancouver, British Columbia V5Z 4H4, Canada.Summary: 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 groups among adolescents after dose 1, or among children under 5 or those aged 5–11 years after any dose. Reported myocarditis/pericarditis cases within 0–28 days peaked among male adolescents following dose 2, in three of (0.037%) 8088 homologous BNT162b2 recipients, and two of (0.529%) 378 homologous mRNA-1273 recipients. Interpretation: Our findings suggest that reported health events, including myocarditis/pericarditis, vary by pediatric age group. Vaccinated adolescents reported health events more frequently following the second mRNA COVID-19 vaccine dose, while younger age groups did not report events more frequently than their unvaccinated counterparts. Funding: Canadian Immunization Research Network, Canadian Institutes of Health Research; Public Health Agency of Canada; COVID-19 Immunity Task Force.http://www.sciencedirect.com/science/article/pii/S2667193X2400276XVaccine safety monitoringAdverse events following immunizationMyocarditis/pericarditis |
| spellingShingle | Phyumar Soe Otto G. Vanderkooi Manish Sadarangani Monika Naus Matthew P. 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 mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in context The Lancet Regional Health. Americas Vaccine safety monitoring Adverse events following immunization Myocarditis/pericarditis |
| title | mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in context |
| title_full | mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in context |
| title_fullStr | mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in context |
| title_full_unstemmed | mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in context |
| title_short | mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort studyResearch in context |
| title_sort | mrna covid 19 vaccine safety among children and adolescents a canadian national vaccine safety network cohort studyresearch in context |
| topic | Vaccine safety monitoring Adverse events following immunization Myocarditis/pericarditis |
| url | http://www.sciencedirect.com/science/article/pii/S2667193X2400276X |
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