Association between COVID-19 vaccines and paediatric safety outcomes in children and adolescents aged 5-19 years in the Nordic countries: Myocarditis, pericarditis and thromboembolic events

Study identification

• EU PAS number:
  EUPAS48979
• Study ID:
  50201
• Official title and acronym:
  Association between COVID-19 vaccines and paediatric safety outcomes in children and adolescents aged 5-19 years in the Nordic countries: Myocarditis, pericarditis and thromboembolic events
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study status:
  Finalised

Research institutions and networks

Institutions

Data Analytic Center (DAC), Danish Medicine Agency

Denmark

Danish Medicines Agency, Data Analytics Centre, Axel Heides Gade 1, DK-2300 Copenhagen S, Denmark, University of Copenhagen, Department of Drug Design and Pharmacology, Pharmacovigilance Research Center, Faculty of Health and Medical Sciences Universitetsparken 2, DK-2100 Copenhagen Ø, Denmark, Statens Serum Institut, Department of Epidemiology Research Artillerivej 5, DK-2300 Copenhagen S, Denmark, Finnish Institute for Health and Welfare POBox 30, FI-00271 Helsinki, Finland, Norwegian Institute of Public Health, Department of Infection, Control and Vaccines P.O.Box 222-Skøyen, NO-0213 Oslo, Norway, Swedish Medical Products Agency, Division of Use and Information SE3751 03 Uppsala, Sweden

Study timelines

Date when funding contract was signed

Planned: 03/08/2022

Actual: 03/08/2022

Study start date

Planned: 03/08/2022

Actual: 03/08/2022

Data analysis start date

Planned: 01/10/2022

Actual: 01/10/2022

Date of final study report

Planned: 03/10/2022

Actual: 03/10/2022

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable