A Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Recipients of the Pfizer-BioNTech COVID-19 mRNA vaccine in the EU

Study type

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

  Disease epidemiology

  Drug utilisation

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)

  FAMTOZINAMERAN

  RAXTOZINAMERAN

  RILTOZINAMERAN

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

  covid-19, RNA-based vaccine

  (J07BX03) covid-19 vaccines

  covid-19 vaccines
• Medical condition to be studied:
  COVID-19 immunisation

Population studied

• Age groups:
  • 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

  Pregnant women
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Estimate the real-world incidence of medically attended safety events of interest and other clinically significant events among individuals vaccinated with the Pfizer-BioNTech COVID-19 mRNA vaccine after authorization in the European Union (EU).
• Outcomes:
  Real-world incidence of medically attended safety events of interest and other clinically significant events among individuals vaccinated with the Pfizer-BioNTech COVID-19 mRNA vaccine after authorization in the European Union, Whether the vaccine recipients experience increased risk of medically attended safety events of interest (SEIs) post vaccination, via comparison with expected background rates and, as feasible, by self-controlled risk interval analysis Incidence rates of medically attended SEIs among subcohorts of interest such as pregnant vaccine recipients, immunocompromised participants, and stratified by age
• Data analysis plan:
  The study population of Pfizer-BioNTech COVID-19 vaccine recipients will be described in terms of demographic and health history characteristics, along with vaccination characteristics such as number of doses received and interval between doses. The incidence rates of medically attended safety events of interest will be estimated in the primary safety dataset of participants who enroll within 2 days of vaccination. Rates will also be estimated for the overall study population and within subcohorts of interest such as pregnant vaccine recipients, immunocompromised participants, and within age categories. The final analysis will also include subcohorts for heterologous vaccination courses. For events with a sufficient number of cases, the observed rate will be compared with expected rates where available from historical or concurrent rates as reported in the scientific literature or other sources. For selected endpoints a SCRI analysis will be implemented if case counts are sufficient.