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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107862
• EU PAS number:
  EUPAS50375
• Study ID:
  107862
• Official title and acronym:
  Active Safety Surveillance of the Pfizer-BioNTech COVID-19 Vaccine in the United States Department of Defense Population Following Emergency Use Authorization
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to answer the research question: What are the incidence rates of safety events of interest (based on adverse events of special interest AESI), overall and in sub-cohorts of interest, among individuals in the United States DoD Military Health System (MHS) vaccinated with the Pfizer-BioNTech COVID-19 Vaccine as compared to expected rates of those events? The primary objectives are 1) 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 one dose, individuals receiving the primary series, and individuals receiving approved booster dose(s) of the Pfizer-BioNTech COVID-19 Vaccine after the primary series and 2) to assess whether sub-cohorts of interest (ie, pregnant women, immunocompromised, elderly, individuals with specific comorbidities, individuals receiving only one dose of the Pfizer-BioNTech COVID-19 Vaccine, and individuals with prior SARS-CoV-2 infection) identified in the DoD MHS experience increased risk of safety events of interest following receipt of the Pfizer-BioNTech COVID-19 Vaccine. This post-EUA active safety surveillance study will employ a retrospective, longitudinal, observational cohort study design. The observed safety event of interest rates in the cohort of individuals who received the Pfizer-BioNTech Vaccine between 11 December 2020 and 30 June 2023 will be compared to expected rates derived in 3 control groups: active comparator cohort, general population comparator cohort, and self-controls. Update: Study C4591011 was terminated in 14 September 2023, the study objectives were addressed by earlier availability of data from multiple other studies with similar study endpoints and analyses. No study reports were prepared.
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

Analysis Group, Inc., The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc., Defense Health Agency

Study timelines

Date when funding contract was signed

Planned: 28/01/2021

Actual: 28/01/2021

Study start date

Planned: 31/01/2023

Actual: 14/09/2023

Date of final study report

Planned: 31/01/2025

Actual: 14/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4591011_PROTOCOL AMENDMENT 2_09AUG2022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)