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OpenTrials
Completed

NCT Number: NCT06199934

Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data

The primary purpose of this study is to learn about how well different versions of the Pfizer-BioNTech COVID-19 vaccine (called BNT162b2) work at preventing death, severe COVID-19 that requires a trip to the hospital, and overall use of healthcare resources, such as needing to go the doctor or urgent care due to illness. Pfizer is not enrolling any participants for this study. Instead, existing data from different health data sources will be used to help answer the scientific questions Pfizer is interested in learning more about.

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Key information

Conditions

SARS-CoV-2 COVID-19 COVID-19 Vaccines Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Global Headquarters

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People with at least one year of pharmacy and medical enrollment in HealthVerity prior to vaccine availability
  • State of California or Louisiana resident for at least one year

Exclusion criteria

  • People currently pregnant,
  • Individuals with discrepancies in sex and/or year of birth between HealthVerity claims and California/Louisiana immunization registry datasets
  • A diagnosis of COVID-19 in any setting ≤ 90 days prior to start of study or receipt COVID-19 vaccine ≤ 90 days prior to start of study.

Treatment and study plan

Vaccination

Biological

BNT162b2 vaccination

Primary outcomes

  1. Number of Participants COVID-19 Diagnosis

    Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

    Number of participants diagnosed with COVID-19 were reported in this outcome measure.

Secondary outcomes

  1. Number of Participants With an Outpatient Encounter

    Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

    Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1.

  2. Number of Participants With an Inpatient Encounter

    Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

    Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1.

  3. Number of Participants With Emergency Department Encounter

    Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

    Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1.

  4. Number of Participants With COVID-19 Critical Illness

    Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

    COVID-19 critical illness was defined as intensive care unit [ICU] admission, mechanical ventilation, or inpatient death.

  5. Number of Participants With Non-COVID-19 Respiratory Infection

    Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

    Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription.

  6. Number of Participants With Negative Control Outcomes

    Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

    Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure.

  7. Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

  8. Average Length of Stay (LOS)

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

    Average length of stay was defined as date of service end minus date of service start.

  9. Number of Participants With ICU Admission Are Included in This Outcome Measure.

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

    Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure.

  10. Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV)

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

  11. Number of Participants With Inpatient Mortality

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

  12. Number of Participants Who Received Antiviral Treatment

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

    Number of participants who received antiviral COVID treatment is reported.

  13. Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

  14. All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

  15. Number of Participants With COVID-19-Related Hospitalization

    Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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