Active Safety Surveillance of the Pfizer-BioNTech COVID-19 Vaccine in the United States Department of Defense Population Following Emergency Use Authorization

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

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)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  To assess whether individuals identified in the DoD MHS experience increased risk of safety events of interest following receipt of the Pfizer-BioNTech COVID-19 Vaccine, specifically in the following groups: individuals receiving at least 1 dose, individuals receiving the primary series, individuals receiving approved booster dose(s) of the Pfizer-BioNTech COVID-19 Vaccine after the primary series
• Outcomes:
  Risk of safety events of interest following receipt of the Pfizer-BioNTech COVID-19 vaccine among various groups of individuals and sub-cohorts of interest in the DoD MHS, The proportion of individuals receiving at least 1 dose of the vaccine, 2-dose and 3-dose vaccine completion rates, booster dose(s) completion rate, distribution of time gaps between doses for the primary series and between completion of the primary series and booster dose(s), demographics and health histories of recipients, overall and among the sub-cohorts of interest
• Data analysis plan:
  The cohort design will compare the incidence of the safety event of interest between a COVID-19 vaccine recipient cohort and the respective comparator cohorts as follows: Multivariate adjustment using Poisson regression will be conducted for the selected safety events of interest, comparing incidence rates of safety events in individuals receiving COVID-19 vaccine to active comparators. Risk of safety events among COVID-19 vaccinated individuals and contemporary unvaccinated controls will be compared using inverse probability of treatment weighting. SCCS design with a post-vaccination control time period will be conducted for the selected safety events of interest. Case validation/adjudication through medical records review may be conducted if a statistically significant finding of association is found. Descriptive statistics will be used to summarize baseline demographics, clinical characteristics, and vaccine utilization patterns. Various subgroup analyses will also be conducted