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

August 21, 2025 updated by: Pfizer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19853610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Pfizer Global Headquarters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were California or Louisiana residents in the HealthVerity claims database will be defined using the following hierarchical definition:

  1. Persons who have their enrollment file record indicating a patient location of California or Louisiana in HealthVerity claims enrollment file.
  2. Persons who have a patient state location other than California or Louisiana in HealthVerity claims enrollment but have one or more records in the California or Louisiana Immunization Registry. Examples include people who previously lived in Texas but moved to California and received a vaccine, or persons who crossed state lines for a vaccine and remain in their non-California state in claims data.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinated
BNT162b2 recipients
Biological: Vaccination
BNT162b2 vaccination
Unvaccinated
BNT162b2 eligible but did not receive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
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.
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
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.
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
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.
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
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.
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
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.
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
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)
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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.
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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.
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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)
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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)
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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.
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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)
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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)
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
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)
From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4591065
  • RAVEN (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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