Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
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) |
|
| 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. |
From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study) |
|
| 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. |
From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study) |
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