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.

Study Overview

• Status: Active, not recruiting
• Conditions: SARS-CoV-2; COVID-19 Vaccines
• Intervention / Treatment: Biological: Vaccination

• Study Type: Observational
• Enrollment (Estimated): 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	Time Frame
Number of people with a COVID-19-related encounter, regardless of setting	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of people with an outpatient encounter with ICD-10-CM U07.1 "COVID-19" code	6 months
Number of people with an inpatient encounter with ICD-10-CM U07.1 "COVID-19" code	6 months
Number of people with an emergency department encounter with ICD-10-CM U07.1 "COVID-19" code	6 months
Number of people with COVID-19 critical illness	6 months
Number of people with non-COVID-19 respiratory infection	6 months
Number of people with negative control outcomes	6 months
COVID-19 hospitalization mean costs will be assessed using the total cost data from administrative healthcare claims dataset	4 months
Average length of stay, in days	4 months
Number of people who had ICU admission	4 months
Number of people who received high-flow oxygen or mechanical ventilation	4 months
Number of people with inpatient mortality	4 months
Number of people who received antiviral treatment	4 months
All-cause healthcare mean costs will be assessed using the cost data from administrative healthcare claims dataset	9 months
All-cause healthcare resource utilization as the total number of encounters, regardless of setting, using data from administrative healthcare claims dataset	9 months
Number of people with COVID-19-related hospitalization	9 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 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 (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; XBB vaccine effectiveness
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• 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