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The problem
Intervention: Administration of mRNA COVID-19 vaccines (BNT162b2 or mRNA-1273), with active safety surveillance monitoring for health events preventing daily activities, causing school absenteeism, or requiring medical consultation
Who it was tested with: Vaccinated (259,361 dose 1; 131,032 dose 2) and unvaccinated (1,179 control) children and adolescents aged 6 months to 19 years across eight Canadian provinces and territories.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"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" and "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." The study uses a prospective cohort design with comparison groups stratified by age and dose, providing experimental-level evidence for vaccine safety outcomes in the pediatric population.
Study relies on self-reported outcomes which may introduce recall or reporting bias; captures only short-to-medium term safety; does not assess long-term outcomes; control group size is small (1,179) compared to vaccinated groups.
Across countries and designs
1 study · 1 country
