HERO-Together Boost: A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer-BioNTech COVID-19 vaccine

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX) Other viral vaccines

  Other viral 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:
  500

Study design details

• Main study objective:
  To estimate the real-world incidence of safety events of interest among recipients of the Pfizer-BioNTech COVID-19 vaccine following EUA
• Outcomes:
  Incidence of safety events of interest among recipients of the Pfizer-BioNTech COVID-19 vaccine following EUA, Incidence rates of safety events of interest among subcohorts of interest, including individuals who are pregnant, individuals who are immunocompromised, and stratified by age
• Data analysis plan:
  Vaccination and baseline characteristics will be summarized using descriptive statistics, including measures of central tendency and dispersion (means, medians, standard deviations) for continuous variables and percentages for categorical variables. The primary analysis for each objective will be restricted to participants who enrolled within 10 days of vaccination to mitigate the risk of selective enrollment and disproportionate representation of higher risk participants. The number and incidence rate for each safety event of interest will be calculated overall, and within subgroups of interest, including pregnant women, immunocompromised individuals, and within age groups. Rates will also be stratified by other baseline characteristics, such as race/ethnicity, work setting, prior COVID-19, and geographic region, data permitting.