An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Self-Controlled Risk Interval

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  COVID-19 VACCINE JANSSEN (AD26.COV2.S)
• Medical condition to be studied:
  Guillain-Barre syndrome

  Myelitis transverse

  Bell's palsy

  Multiple sclerosis

  Autoimmune thyroiditis

  Thrombocytopenia

  Immune thrombocytopenia

  Type 1 diabetes mellitus

  Acute aseptic arthritis

  Anaphylactic reaction

  Asthmatic crisis

  Myocarditis

  Microangiopathy

  Heart failure with preserved ejection fraction

  Stress cardiomyopathy

  Coronary artery disease

  Arrhythmia

  Deep vein thrombosis

  Pulmonary embolism

  Disseminated intravascular coagulation

  Haemorrhagic stroke

  Ischaemic stroke

  Cerebral venous sinus thrombosis

  Thrombosis with thrombocytopenia syndrome

  Acute kidney injury

  Hepatic failure
• Additional medical condition(s):
  Not exhaustive list

Population studied

• Age groups:
  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:
  370000

Study design details

• Main study objective:
  This study has 2 chronologically consecutive aims: 1) to conduct a feasibility assessment aiming to inform the safety evaluation study and 2) to assess the risk of developing pre-specified and newly identified AESIs following administration of Ad26.COV2.S.
• Outcomes:
  predefined and newly identified AESIs among individuals exposed to Ad26.COV2.S
• Data analysis plan:
  For the feasibility analysis the utilization patterns of Ad26.COV2.S and other COVID-19 vaccines will be characterized and monitored over time. The primary analysis will focus on the calculation and comparison of the incidence rates of each non-acute AESI between individuals exposed to Ad26.COV2.S and (1) unexposed individuals, (2) individuals exposed to another viral vector COVID-19 vaccine (ie, Vaxzevria® AZD1222 byOxford/AstraZeneca), and 3) individuals exposed receiving a mRNA COVID-19 vaccine (cohort).For acute events, the relative risk between risk window and control window will be estimated(SCRI) among individuals exposed to Ad26.COV2.S.

Documents

Study results

REDACTED_CSR-Body-VAC31518COV4003-1474544_1552148.pdf