Breakthrough Infection, Covid-19, Immunocompromised, Immunosuppressed, SARS-COV-2, SARS-COV-2 Infection
Conditions
Keywords
Immunocompromised, Immunosuppressed, Immunosuppressive drugs, Covid-19, Covid-19 Vaccination, mRNA Vaccine, SARS-CoV-2 Vaccine, BNT162b2, Breakthrough Infection, SARS-COV-2 Infection, SARS-COV-2
Brief summary
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Detailed description
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.
Interventions
BIOLOGICALBNT162b2 (Tozinameran)
Covid-19 Vaccine
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection | 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) | 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 to SARS-CoV-2 Breakthrough Infection | 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 was calculated as the number of days from Dose 2 of vaccination till first occurrence of a breakthrough SARS-CoV-2 infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection | 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) | 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 | 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) | 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 | 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) | 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 With Emergency Department Visits After SARS-CoV-2 Infection | 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) | 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 Died During Hospitalization After SARS-CoV-2 Infection | 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) | 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 | 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 duration of stay was total time spend by the participant for different types of hospitalization treatments, applicable for first hospitalization and/or readmissions. |
| Total Expenditure on Healthcare Resource Utilization (HCRU) After SARS-CoV-2 Infection | 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 HCRU was defined as total non-zero costs associated with any of the previously listed outpatient and inpatient encounters. |
| Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection | 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) | 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 With Outpatient Hospital Visits After SARS-CoV-2 Infection | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Data of participants aged 12 years or more with at least 1 BNT162b2 vaccine claim between 10 Dec 2020 to 08 Jul 2021 examined for COVID-19 breakthrough infections (vaccination greater than equal to \[\>=\] 14 days after 2nd dose) in real-world practice, were retrieved from US HealthVerity database. Available data were extracted and evaluated during approximately 4 months of this retrospective observational study.
Participants by arm
| Arm | Count |
|---|---|
| BNT162b2 (Tozinameran): IC Cohort Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose. | 225,796 |
| BNT162b2 (Tozinameran): Non-IC Cohort Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm. | 1,051,951 |
| Total | 1,277,747 |
Baseline characteristics
| Characteristic | BNT162b2 (Tozinameran): IC Cohort | BNT162b2 (Tozinameran): Non-IC Cohort | Total |
|---|---|---|---|
| Age, Continuous | 55.4 Years STANDARD_DEVIATION 15.2 | 44.1 Years STANDARD_DEVIATION 16.9 | 46.1 Years STANDARD_DEVIATION 17.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Female | 127101 Participants | 558164 Participants | 685265 Participants |
| Sex/Gender, Customized Male | 96835 Participants | 476804 Participants | 573639 Participants |
| Sex/Gender, Customized Unknown | 1860 Participants | 16983 Participants | 18843 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection | 0.89 Events per 100 person-years |
| BNT162b2 (Tozinameran): Non-IC Cohort | Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection | 0.34 Events per 100 person-years |
Primary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Time to SARS-CoV-2 Breakthrough Infection | 34.5 Days |
| BNT162b2 (Tozinameran): Non-IC Cohort | Time to SARS-CoV-2 Breakthrough Infection | 33 Days |
Secondary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection | With ICU admission and no IMV usage | 15 Participants |
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection | With ICU admission and IMV usage | 8 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection | With ICU admission and no IMV usage | 9 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection | With ICU admission and IMV usage | 1 Participants |
Secondary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants Died During Hospitalization After SARS-CoV-2 Infection | 2 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants Died During Hospitalization After SARS-CoV-2 Infection | 0 Participants |
Secondary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants Hospitalized After SARS-CoV-2 Infection | 74 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants Hospitalized After SARS-CoV-2 Infection | 50 Participants |
Secondary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection | With ICU admission and IMV usage | 8 Participants |
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection | No ICU admission with IMV usage | 1 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection | With ICU admission and IMV usage | 1 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection | No ICU admission with IMV usage | 0 Participants |
Secondary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection | 95 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection | 72 Participants |
Secondary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection | 309 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection | 527 Participants |
Secondary
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.
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)
Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 (Tozinameran): IC Cohort | Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection | 146 Participants |
| BNT162b2 (Tozinameran): Non-IC Cohort | Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection | 164 Participants |
Secondary
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)
Population: Data was not collected and analyzed for this outcome measure as per Sponsor discretion.
Secondary
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)
Population: Data was not collected and analyzed for this outcome measure as per Sponsor discretion.