Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

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

Study drug and medical condition

• Medical condition to be studied:
  Narcolepsy

  Acute aseptic arthritis

  Thrombocytopenia

  Microangiopathy

  Cardiac failure

  Arrhythmia

  Myocarditis

  Embolism

  Haemorrhage

  Liver injury

  Encephalitis

  Erythema multiforme

  Pernio-like erythema

  Anosmia

  Anaphylactic reaction

  COVID-19

  Stillbirth

  Death
• Additional medical condition(s):
  Stress cardiomyopatly, Generalized convulsion, Multisystem Inflammatory disease, Preeclampsia, Major congenital anomaly

Population studied

• Short description of the study population:
  The study population included individuals registered in health insurance data (BIPS, SNDS), hospitalisation record linkage data (PHARMO, Danish registries, FISABIO, SIDIAP, ARS) or data from general practitioners (CPRD, PEDIANET, BIFAP) from 2017 to 2020, including the period of SARS-CoV-2 circulation in Europe until the date of last data availability for each data source.
• 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:
  130

Study design details

• Main study objective:
  To generate background incidence rates of adverse events of special interest (AESI) that may be used to monitor benefit-risk profile of upcoming COVID-19 vaccines.
• Outcomes:
  Incidence rates of adverse events of special interest (AESI) and pregnancy outcomes in the general population by calendar year and data source over the period 2017 to 2020, Weekly and monthly incidence rates of COVID-19 (overall and by severity level) in 2020 by data source, Monthly incidence rates of multisystem inflammatory syndrome in children (MIS-C) in 2020 by data source. Incidence rates of AESI by calendar month, year, sex, age group, and data source over the period 2017 to 2020, Incidence rates of multisystem MIS-C in 2020 by month, sex, age group, and data source, Prevalence of high-risk medical conditions for developing severe COVID-19 by year and data source, incidence rates of AESI in the at-risk population by year, sex, age group, and data source
• Data analysis plan:
  Incidence rates (and 95%CI) of AESI and pregnancy outcomes by calendar year will be calculated by dividing the number of incident (new) cases by the total person-time at risk. Prevalence rates (and 95%CI) of at-risk medical conditions for developing severe COVID-19 by calendar year will be calculated by dividing the number of existing cases in a year by the average of the total number of persons recorded monthly. Incidence rates (and 95%CI) of AESI among at-risk populations will also be computed. Sensitivity analyses will be conducted according to the time prior to SARS-CoV2 circulation and during SARS-CoV2 circulation period to investigate the impact of circulating virus on incidence rates.

Documents

Results tables

ACCESS Final Report Zenodo link

Study publications

Willame C, Dodd C, Durán CE, Elbers R, Gini R, Bartolini C, Paoletti O, Wang L,…

Willame C, Dodd C, Durán CE, Elbers RJ, Gini R, Bartolini C, Paoletti O, Wang L…