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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Pfizer-BioNTech BNT162b2(original monovalent) COVID-19 Vaccine
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN01) covid-19, RNA-based vaccine

  covid-19, RNA-based vaccine
• 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

• Study design:
  Retrospective cohort design of individuals with concurrent unexposed comparators
• 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.
• Setting:
  The source population for this study will be health plan enrollees from 5 data research partners that contribute data from claims and electronic health records to the Sentinel System: CVS Health/Aetna, Carelon Research, HealthPartners, Humana, and Optum.
• 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.