COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States

N/ACompletedNCT05020145

Pfizer1,277,747 enrolled

Overview

This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.

The objective of this US-based retrospective cohort study is to evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination. Subjects will be aged 12 years and older and will have no evidence of prior SARS-CoV-2 infection. The primary analysis will be conducted on subjects vaccinated with BNT162b2. A variety of subgroup analyses and sensitivity analyses are planned.

Study Type

OBSERVATIONAL

Enrollment

1,277,747

Conditions

Immunocompromised Immunosuppressed Covid-19 SARS-COV-2 SARS-COV-2 Infection Breakthrough Infection

Interventions

BNT162b2 (Tozinameran)BIOLOGICAL

Covid-19 Vaccine

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Unique enrollees in the HealthVerity Vaccine dataset anytime after December 10, 2020 2. At least 12 years on the index date (ie, first vaccination date) 3. No evidence of prior COVID-19 infection (a medical claim, pharmacy claim, or chargemaster record with a diagnosis code of ICD-10-CM U07.1) in the 12 months prior to the index date 4. Have 12 months of continuous enrollment with medical benefits (with or without pharmacy benefits) prior to the index date. Subjects with an IC condition will be identified via an algorithm developed for use in administrative claims database studies. Exclusion criteria: subjects not meeting the criteria above will be excluded.

Locations (1)

Pfizer Inc.

New York, New York, United States

Outcomes

Primary Outcomes

Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

The incidence rate of breakthrough cases of SARS-CoV-2 infection was calculated as the number of participants who experienced the event divided by the observed time at risk and reported as incidence rate per 100 person-years. Rate of breakthrough SARS-CoV-2 infection among fully vaccinated participants was reported in this outcome measure.

Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)

Time to SARS-CoV-2 Breakthrough Infection

Time to SARS-CoV-2 breakthrough infection was calculated as the number of days from Dose 2 of vaccination till first occurrence of a breakthrough SARS-CoV-2 infection.

Secondary Outcomes

Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection

In this outcome measure, number of participants with emergency department visits who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed. Emergency department visits included an outpatient claim that occurs after the breakthrough COVID-19 diagnosis date or at the same time or episode of care.

Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection

In this outcome measure, number of participants with outpatient hospital visits who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed. Outpatient hospital visits included an outpatient claim that occurs after the breakthrough COVID-19 diagnosis date or at the same time or episode of care other than emergency department visits.

Data from ClinicalTrials.gov

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Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection

In this outcome measure, number of participants with other outpatient visits (excluding emergency department visits and outpatient hospital visits) who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.

Number of Participants Hospitalized After SARS-CoV-2 Infection

In this outcome measure, number of participants hospitalized who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.

Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection

In this outcome measure, number of participants admitted to ICU with or without Invasive Mechanical Ventilation (IMV) during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.

Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection

In this outcome measure, number of participants who received IMV with or without ICU admission during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.

Number of Participants Died During Hospitalization After SARS-CoV-2 Infection

In this outcome measure, number of participants who died during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.

Total Duration of Stay in Hospital After SARS-CoV-2 Infection

Total duration of stay was total time spend by the participant for different types of hospitalization treatments, applicable for first hospitalization and/or readmissions.

Time frame: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)

Total Expenditure on Healthcare Resource Utilization (HCRU) After SARS-CoV-2 Infection

Total expenditure on HCRU was defined as total non-zero costs associated with any of the previously listed outpatient and inpatient encounters.

Time frame: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)