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

Completed

Conditions studied: SARS-CoV-2, COVID-19, Post-Acute COVID-19 Syndrome

In brief

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.

Key facts

Study ID

NCT05876377

Run by

Pfizer

People needed

1

Starts

2023-10-23

Expected to finish

2026-05-31

Last updated by the study team

2026-06-30

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria to be eligible for inclusion in the study:
• 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)
• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• 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
• And does not have discrepancies in sex and/or year of birth between HealthVerity claims and state Immunization registry datasets.
• This analysis will be stratified by age: 12-17, 18-49. 50-64, 65-74, 75+, which will be measured as of August 31, 2022.
• By Age, Bivalent (younger children)
• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• Has medical and pharmacy enrollment in HealthVerity as of 12 October 2022
• And is age 5-11 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

Where it is running

• Pfizer — New York, New York, United States

Full record on ClinicalTrials.gov

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