Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran’s Affairs Health System Receiving Pfizer BioNTech Coronavirus Disease 2019 (COVID 19) Vaccine

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103367
• EU PAS number:
  EUPAS39779
• Study ID:
  103367
• Official title and acronym:
  Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran’s Affairs Health System Receiving Pfizer BioNTech Coronavirus Disease 2019 (COVID 19) Vaccine
• 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) among individuals vaccinated with the Pfizer-BioNTech COVID 19 vaccine within the US Veterans Health Administration (VHA) system overall and in sub-cohorts of interest, as compared to expected rates of those events? The primary study objectives are: 1) to assess whether the following groups of individuals in the VHA system experience increased risk of safety events of interest following receipt of the Pfizer-BioNTech COVID-19 vaccine: individuals receiving first dose, individuals receiving the primary series of two doses, individuals receiving additional approved dose(s) of the Pfizer-BioNTech COVID-19 vaccine after the primary series of two doses and 2) to assess whether sub-cohorts of interest (i.e. immunocompromised, elderly, individuals with specific comorbidities, individuals receiving only one dose of the Pfizer-BioNTech COVID-19 vaccine, individuals with prior SARS-CoV-2 infection, individuals with regular use of VHA medical care, VA priority group 1 Veterans, and individuals with dual coverage of VHA and Medicare) in the VHA system experience increased risk of safety events of interest following receipt of the Pfizer-BioNTech COVID-19 vaccine. This post-EUA active safety surveillance program will employ a rapid-cycle, longitudinal, observational cohort study design to provide early real-world safety information. The self-controlled risk interval design will be used to sequentially monitor occurrence of safety events of interest while controlling for time-invariant confounders. An active comparator design will be used to sequentially monitor occurrence of safety events of interest with Pfizer-BioNTech COVID-19 vaccinations as compared to recipients of influenza vaccine in the VHA. Additional study designs will be conducted if a signal is detected from these analyses.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Analysis Group, Inc., U.S. Department of Veterans Affairs

Study timelines

Date when funding contract was signed

Planned: 13/11/2020

Actual: 13/11/2020

Study start date

Planned: 01/05/2021

Actual: 11/03/2021

Date of final study report

Planned: 31/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4591012 VHA Protocol_1.27.2021_Final 27 JAN 2021

Updated protocol

C4591012_PROTOCOL AMENDMENT 5_V6_31JAN2023

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)