Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, multi-database, self-controlled risk interval study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  200000015711

  covid-19 vaccines
• Medical condition to be studied:
  Guillain-Barre syndrome
• Additional medical condition(s):
  All COVID-19 AESI

Population studied

• Short description of the study population:
  The study involved three cohorts: readiness, rapid assessment, and methodological assessment. Readiness cohort included subjects in the source population who were in follow-up for at least 365 days or were born during the study period. Rapid assessment cohort included subjects with the outcome of interest and a COVID-19 vaccination, while methodological assessment cohort included vaccinated subjects and different matched comparisons.; Inclusion Criteria:; Readiness study:; For the readiness study, the person will be included if there is at least one day of follow-up and the person has at least 12 months of data in the data source at the start of follow-up. ; SCRI Design: ; For analyses of outcomes assessed with the SCRI design, the following criteria must be met. Note that the study population for each outcome-specific analysis will thus be different.; • Received a dose of COVID-19 vaccine during the study period.; • Have experienced a specific event of interest during the predefined observation period.; • Have at least 12 months of data/registration in the data sources at study entry.; Cohort design:; Individuals must meet all the following inclusion criteria to be eligible for inclusion in the cohort study:; • At time zero, being in the underlying population of the data source for at least 12 months; or, being born in the previous 12 months in the underlying population.; • Study participants must be eligible (eg, lack of contra-indications) to receive the COVID-19 vaccines at time zero. ; Exclusion Criteria:; For the readiness study, there will be no exclusion criteria.; Individuals will be excluded from the rapid assessment studies if:; • They have a recorded diagnosis for the specific event in the one year prior to cohort /SCRI entry. Persons with such acute diagnoses more than a year ago will be maintained to allow for subgroup analyses. Upon investigation of one event, we do not exclude any history or prevalence of other groups of events (AESIs).; • They have a contra-indicati
• 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)
• Estimated number of subjects:
  59000000

Study design details

• Main study objective:
  The objective of the COVID-Vaccine Monitor study is to rapidly assess signals of potential safety concerns emerging from active surveillance and identified by PRAC.
• Data analysis plan:
  Risk estimation: IRR

Documents

Results tables

D4.2_CVM_ExecutiveSummary_WP3-4_20230714

D4.2_CVM_FinalReport_WP3-4_14082023_ExSumm

Study, other information

FollowUp_version_CVM_WP3_Protocol_v2.1

Study publications

Bots SH, Riera-Arnau J, Belitser SV, Messina D, Aragón M, Alsina E, Douglas IJ,…

Durán, Carlos E., Messina, Davide, Gini, Rosa, Riefolo, Fabio, Aragón, María, B…