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

NCT06199934 | Completed Results FDA Drug

• 2 other identifiers: C4591065RAVEN
• Study Type: observational
• Target: 19,853,610
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV-2; COVID-19 Vaccines

Keywords

COVID-19; XBB vaccine effectiveness

Outcome Measures

Primary Outcomes (1)

• Number of Participants COVID-19 Diagnosis

  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 Outcomes (15)

• Number of Participants With an Outpatient Encounter

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

• Number of Participants With an Inpatient Encounter

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

• Number of Participants With Emergency Department Encounter

  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

  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

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

Study Arms (2)

Vaccinated

BNT162b2 recipients

Biological: Vaccination

Unvaccinated

BNT162b2 eligible but did not receive

Interventions

Vaccination BIOLOGICAL

BNT162b2 vaccination

Vaccinated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Global Headquarters

New York, New York, 10001, United States

Location

Related Publications (2)

• Andersen KM, McColgan MD, Mateus JS, Yu T, Zhou A, Puzniak L, Lopez SMC. BNT162b2 XBB.1.5-Adapted Single Dose Vaccine Uptake and Effectiveness in Children Aged 5-17 Years Using Linked Claims and Vaccine Registries in California and Louisiana. J Pediatr. 2025 Nov;286:114778. doi: 10.1016/j.jpeds.2025.114778. Epub 2025 Aug 14.

  PMID: 40818804 DERIVED

• Andersen KM, Allen KE, Nepal RM, Mateus JS, Yu T, Zhou A, Porter TM, Lopez SMC, Puzniak L, McLaughlin JM, McGrath LJ. Effectiveness of BNT162b2 XBB.1.5 vaccine in immunocompetent adults using tokenization in two U.S. states. Vaccine. 2025 Apr 11;52:126881. doi: 10.1016/j.vaccine.2025.126881. Epub 2025 Feb 22.

  PMID: 39987879 DERIVED

Related Links

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

MeSH Terms

Conditions

COVID-19

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 10, 2024
• Study Start: September 11, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)