Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary and secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, multi-database, dynamic study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BC20) combinations
• Medical condition to be studied:
  Coagulopathy
• Additional medical condition(s):
  Cardiovascular, Immunological

Population studied

• Short description of the study population:
  The study involved participants from 4 European countries, including Italy, the Netherlands, Spain, and the United Kingdom, spanning from January 1st, 2020 to October 31st, 2021. The source population consisted of approximately 36 million individuals, with 7 million in the Netherlands, 8 million in Spain, 3.5 million in Italy, and 16 million in the UK.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  5000000

Study design details

• Main study objective:
  To monitor the use and effects of COVID-19 vaccines
• Data analysis plan:
  Risk estimation

Documents

Study publications

Sturkenboom M, Messina D, Paoletti O, de Burgos-Gonzalez A, García-Poza P, Huer…

Sturkenboom M. Cohort monitoring of Adverse Events of Special Interest and COVI…