Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation
• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  200000015711

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

Population studied

• 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:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  13225000

Study design details

• Main study objective:
  To determine whether an increased risk of prespecified AESI exists following the administration of at least one dose the Pfizer-BioNTech COVID 19 vaccine using two approaches: (a) a cohort design comparing risk in vaccinated and non-vaccinated individuals and (b) a self-controlled risk interval (SCR
• Outcomes:
  Risk of prespecified AESI following the administration of at least one dose the Pfizer-BioNTech COVID-19 vaccine using two approaches: (a) a cohort design comparing risk in vaccinated and non-vaccinated individuals and (b) a self-controlled risk interval (SCRI) design, Incidence rates of prespecified AESI among individuals who receive at least one dose of the Pfizer-BioNTech COVID-19 vaccine using a cohort study design and compared with a matched comparator group with no COVID-19 vaccination within subcohorts of interest, including pregnant people and their neonates. Utilization patterns of Pfizer-BioNTech COVID-19 vaccine among individuals within Europe.
• Data analysis plan:
  The distributions of baseline characteristics at time zero by exposure group will be calculated to describe the study cohort and illustrate differences between the groups. For safety outcomes, the risk over specific time period(s), incidence rates and their corresponding 95% confidence intervals (CIs) will be computed after the receipt of first, second, and subsequent doses. Crude risks, cumulative incidence over different time periods, and measures of association for each AESI after vaccination will be estimated in the entire population overall and separately by number of doses received. Subgroup analyses will be conducted by demographic and clinical characteristics as well as other covariates of interest. To account for potential confounding, propensity score methods will be used to estimate the adjusted risk ratios and 95% CIs. Appropriate random-effects meta-analytic methods will be used to obtain a combined effect estimate. Where appropriate, the study will also use a SCRI design.

Documents

Study report

C4591021_PROGRESS REPORT_27SEP2021

Study, other information

C4591021_PROTOCOL AMENDMENT 2_31MAR2022