Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data

NCT05876377 | Active Not Recruiting FDA Drug

• 2 other identifiers: C4591059NCT05876377
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to use vaccination information from state vaccine registries linked with HealthVerity insurance claims for the following:

• to measure how effective the Pfizer-BioNTech vaccine is at preventing post-COVID conditions.
• to understand characteristics of patients who are receiving COVID-19 vaccines. All patients whose information is kept unidentified in the HealthVerity database are eligible to be included for both aims of this study.

Conditions

SARS-CoV-2; COVID-19; Post-Acute COVID-19 Syndrome

Keywords

COVID-19 Vaccines; COVID-19 Drug Treatment

Outcome Measures

Primary Outcomes (2)

• Aim 1: Any PCC-related diagnosis not present before the COVID-19 diagnosis

  The primary endpoint is any PCC-related diagnosis as defined by Xie et al. (2024, NEJM) that occurs between 30 and 180 days following a COVID-19 diagnosis and was not present before the COVID-19 diagnosis. The primary endpoint will also be stratified by specific organ system / disease domains (cardiovascular; coagulation and hematologic; fatigue; gastrointestinal; kidney; mental health; metabolic; musculoskeletal; neurologic; and, pulmonary). All patients are required to have a diagnosis of COVID-19 (ICD-10-CM code = U07.1) as a predicating event for the subsequent evaluation of a PCC episode. The first 30 days after the diagnosis of COVID-19 will be excluded from the evaluation of a PCC episode as the acute infection period. The evaluation of the PCC episode will begin on Day 30 after the date of acute COVID-19 diagnosis through day 180.

  30-180 days after COVID-19 diagnosis

• Aim 2: Number of patients with a COVID-19 vaccination

  Any record of COVID-19 vaccination as recorded in the state immunization registry.

  Date of vaccine authorization through the end of the corresponding respiratory season

Study Arms (2)

KP.2 Vaccinated (exposed)

≥14 days since receipt of Pfizer/BioNTech KP.2 dose prior to COVID-19 diagnosis

Biological: Pfizer-BioNTech COVID-19 mRNA vaccine

2024/2025 COVID-19 Unvaccinated (unexposed)

Did NOT receive any 2024/2025 formulated COVID-19 vaccine dose at least 14 days prior to COVID-19 diagnosis.

Interventions

Pfizer-BioNTech COVID-19 mRNA vaccine BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine, is FDA licensed or authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Also known as: Pfizer-BioNTech COVID-19 Vaccine

KP.2 Vaccinated (exposed)

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be sourced from HealthVerity and include patients who are enrolled in the claims database as well as recorded in contributing states' deidentified vaccine registries. Patients who will be followed for the PCC endpoint must be eligible to receive the licensed/authorized vaccine during the study period.

You may qualify if:

• Patients are required to have a COVID-19 diagnosis on or after September 5, 2024 AND no later than August 26, 2025
• Patients in HealthVerity database and residing in California or Louisiana as of index date AND
• Have ≥1 year of pharmacy and medical enrollment in HealthVerity prior to cohort entry date, allowing for up to a 30-day gap in enrollment AND
• ≥18 years old as of index date AND
• Have resided only in their respective state (California or Louisiana) for ≥1 year prior to index date

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• Patients who were immunocompromised from 1 year prior to cohort entry OR
• Patients who received any 2024-2025 formulation of the COVID-19 vaccine prior to authorization (22 August 2024) OR
• Patients who have discrepancies in sex and/or year of birth between HealthVerity claims and state immunization registry datasets OR
• Patients who had a prior diagnosis of COVID-19 ≤180 days preceding cohort entry OR
• Patients who received any 2024/2025 formulation of the COVID-19 vaccine within 0 to 13 days prior OR 0 to 29 days post index COVID-19 diagnosis (i.e., -13 to +29 days around the index date)
• Aim 2:
• By Age, Bivalent (older children, adults)
• Has medical and pharmacy enrollment in HealthVerity as of August 31, 2022
• And is age ≥12 years
• With 6 months of continuous medical and pharmacy enrollment before calendar index date
• And does not have evidence of moderate/severe immunocompromise as defined by CDC
• And has evidence of ≥2 doses of COVID-19 original vaccine formulation before the calendar index date
• And does not have original vaccine formulation within 2 months before calendar index date
• And does not have a pregnancy start date within 9 months before or any point after calendar entry

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

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

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

BNT162 Vaccine

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: May 25, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)