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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Vaccinated
BNT162b2 recipients
Biological: Vaccination
BNT162b2 vaccination
Unvaccinated
BNT162b2 eligible but did not receive

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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