DARWIN EU® Effectiveness of COVID-19 vaccines on severe COVID-19 and post acute outcomes of SARS-CoV-2 infection

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  COMIRNATY

  SPIKEVAX
• Name of medicine, other:
  COVID-19 vaccines BNT162b2 and mRNA-1273
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)

  DAVESOMERAN

  ELASOMERAN

  FAMTOZINAMERAN

  IMELASOMERAN

  RAXTOZINAMERAN

  RILTOZINAMERAN

  TOZINAMERAN
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN01) covid-19, RNA-based vaccine

  covid-19, RNA-based vaccine
• Medical condition to be studied:
  COVID-19
• Additional medical condition(s):
  Severe COVID-19 and post-acute outcomes of SARSCoV-2 infection

Population studied

• Short description of the study population:
  All subjects aged 12 years and older, with at least 365 days of data availability before index date (ID) [ID defined as the date of the latest vaccine dose administered] AND data availability from 12/2020 onwards (i.e. the time when the roll-out of the vaccination campaign started) in the respective database will be included.
• Age groups:
  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:
  10190000

Study design details

• Study design:
  Population-level cohort studies
• Main study objective:
  To assess the effectiveness and waning of effectiveness of COVID-19 vaccination for the prevention of severe COVID-19 related outcomes.
• Outcomes:
  COVID-19 related hospitalisation or COVID-19 related death. To assess the effectiveness of COVID-19 vaccination for the prevention of post-acute all-cause mortality in the 3- and 6-months following discharge for COVID-19 related hospitalisation.
• Data analysis plan:
  All analyses will be conducted separately for each database and will be carried out in a federated manner allowing analyses to be run locally without sharing patient level data. Before sharing the study package test runs of the analytics will be performed on a subset of the data sources and quality control checks will be performed. ; After all the tests are passed see section 11 Quality Control the final package will be released in a version controlled study repository for execution against all the participating data sources. ; The data partners will locally execute the analytics against the OMOP CDM in R Studio and review and approve the by default aggregated results. They will then be made available to the Principal Investigators and study team in the Digital Research Environment. ; All results were locked and timestamped for reproducibility and transparency.

Documents

Study report

DARWIN EU_Report_P2-C3-002_CoVVaccineEffectiveness_V5.pdf

P2-C3-002 Executive Summary_V3.pdf