Effectiveness of Pfizer-BioNTech COVID-19 mRNA vaccine against severe illness in the elderly and immunocompromised patients in Finland (RWE_COVID19_2023)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  COMIRNATY
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN01) covid-19, RNA-based vaccine

  covid-19, RNA-based vaccine
• Medical condition to be studied:
  COVID-19

  COVID-19 pneumonia

  Hospitalisation

Population studied

• Short description of the study population:
  Elderly adults 65 years of age and older living in Finland and immunocompromised patients 12 years of age and older with an active immunocompromised condition.
• Age groups:
  Paediatric Population (< 18 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

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

  Other
• Special population of interest, other:
  Elderly
• Estimated number of subjects:
  1400000

Study design details

• Study design:
  A population-based nationwide cohort study using Finnish health registers.
• Main study objective:
  To estimate the effectiveness of the Pfizer-BioNTech COVID-19 mRNA vaccine booster in preventing COVID-19-related hospital admission in the community-dwelling elderly and in the immunocompromised patients.