A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX03) covid-19 vaccines

  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:
  1

Study design details

• Main study objective:
  To estimate the relative risk of safety events of interest (including myocarditis/pericarditis) following receipt of a first, second, or third dose in a primary series of Pfizer-BioNTech COVID-19 Vaccine compared with no receipt of any COVID-19 vaccine within the overall study population and subgroups of pregnant women, immunocompromised individuals, and individuals with a history of COVID-19.
• Outcomes:
  Adverse events of special interest as listed in the protocol, Among the overall study population and subgroups of interest: the proportion of individuals receiving the Pfizer-BioNTech COVID-19 vaccine, stratified by number of doses, timing and type of second/third doses, demographics and comorbidities.
• Data analysis plan:
  Descriptive analysis will report on utilization of Pfizer-BioNTech COVID-19 Vaccine during the overall study period and in sequential increments of time. Characteristics of the matched and unmatched cohorts will be shown in a table. Vaccinated individuals will be matched to concurrent unexposed comparators. Confounding will be addressed through propensity score matching or through the inclusion of propensity scores in exposure-outcome regression models. In each data source, crude measures of incidence or prevalence of the study outcomes with associated 95% confidence intervals (CIs) will be estimated within the matched exposed and unexposed cohorts. Cox models or Poisson regression will be used to estimate risk ratios and 95% CIs for general safety events in the overall population and subgroups of interest. Sensitivity analyses will incorporate a self-controlled risk interval design or a cohort design with historical comparators in a period before the introduction of COVID-19 vaccines.

Documents

Study, other information

C4591009_PROTOCOL AMENDMENT 2_V3_07JUL2022