COVID-19 Vaccines, SARS-CoV-2
Conditions
Keywords
COVID-19, XBB vaccine effectiveness
Brief summary
The primary purpose of this study is to learn about how well different versions of the Pfizer-BioNTech COVID-19 vaccine (called BNT162b2) work at preventing death, severe COVID-19 that requires a trip to the hospital, and overall use of healthcare resources, such as needing to go the doctor or urgent care due to illness. Pfizer is not enrolling any participants for this study. Instead, existing data from different health data sources will be used to help answer the scientific questions Pfizer is interested in learning more about.
Interventions
BIOLOGICALVaccination
BNT162b2 vaccination
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* People with at least one year of pharmacy and medical enrollment in HealthVerity prior to vaccine availability * State of California or Louisiana resident for at least one year
Exclusion criteria
* People currently pregnant, * Individuals with discrepancies in sex and/or year of birth between HealthVerity claims and California/Louisiana immunization registry datasets * A diagnosis of COVID-19 in any setting ≤ 90 days prior to start of study or receipt COVID-19 vaccine ≤ 90 days prior to start of study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants COVID-19 Diagnosis | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) | Number of participants diagnosed with COVID-19 were reported in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Inpatient Encounter | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) | Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1. |
| Number of Participants With Emergency Department Encounter | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) | Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1. |
| Number of Participants With COVID-19 Critical Illness | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) | COVID-19 critical illness was defined as intensive care unit \[ICU\] admission, mechanical ventilation, or inpatient death. |
| Number of Participants With Non-COVID-19 Respiratory Infection | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) | Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription. |
| Number of Participants With Negative Control Outcomes | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) | Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure. |
| Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | — |
| Average Length of Stay (LOS) | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | Average length of stay was defined as date of service end minus date of service start. |
| Number of Participants With an Outpatient Encounter | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) | Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1. |
| Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV) | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | — |
| Number of Participants With Inpatient Mortality | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | — |
| Number of Participants Who Received Antiviral Treatment | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | Number of participants who received antiviral COVID treatment is reported. |
| Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | — |
| All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | — |
| Number of Participants With COVID-19-Related Hospitalization | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | — |
| Number of Participants With ICU Admission Are Included in This Outcome Measure. | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) | Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure. |
Countries
United States
Participant flow
Recruitment details
Data from adult and pediatric participants who were residents of California or Louisiana were collected from immunization registry linked to closed claims from HealthVerity in this retrospective study. Data was collected from HealthVerity Database from 11-Sep-2023 to 12-Mar-2024, available data was evaluated from 07-Feb-2024 to 31-Jul-2024.
Pre-assignment details
A total of 19853610 participants were enrolled this study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included. | 19,853,610 |
| Total | 19,853,610 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 38.4 Years STANDARD_DEVIATION 22.03 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female | 10455294 Participants | — |
| Sex/Gender, Customized Male | 9340840 Participants | — |
| Sex/Gender, Customized Unknown/missing | 57476 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants COVID-19 Diagnosis
Number of participants diagnosed with COVID-19 were reported in this outcome measure.
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants COVID-19 Diagnosis | 210902 Participants |
Secondary
All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset | 10.04 Encounters | Standard Deviation 19.85 |
Secondary
Average Length of Stay (LOS)
Average length of stay was defined as date of service end minus date of service start.
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Average Length of Stay (LOS) | 6.11 Days | Standard Deviation 7.99 |
Secondary
Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset | 9563.85 US Dollars | Standard Deviation 134821.3 |
Secondary
Number of Participants Who Received Antiviral Treatment
Number of participants who received antiviral COVID treatment is reported.
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Who Received Antiviral Treatment | 41774 Participants |
Secondary
Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV)
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV) | 863 Participants |
Secondary
Number of Participants With an Inpatient Encounter
Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1.
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With an Inpatient Encounter | 11172 Participants |
Secondary
Number of Participants With an Outpatient Encounter
Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1.
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With an Outpatient Encounter | 130171 Participants |
Secondary
Number of Participants With COVID-19 Critical Illness
COVID-19 critical illness was defined as intensive care unit \[ICU\] admission, mechanical ventilation, or inpatient death.
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With COVID-19 Critical Illness | 3905 Participants |
Secondary
Number of Participants With COVID-19-Related Hospitalization
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With COVID-19-Related Hospitalization | 12129 Participants |
Secondary
Number of Participants With Emergency Department Encounter
Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1.
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Emergency Department Encounter | 28010 Participants |
Secondary
Number of Participants With ICU Admission Are Included in This Outcome Measure.
Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure.
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With ICU Admission Are Included in This Outcome Measure. | 2864 Participants |
Secondary
Number of Participants With Inpatient Mortality
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Data was not collected for this outcome measure as mortality information in the HealthVerity data was delayed several months behind real time, to protect confidentiality, and were not available at the time of analyses for the study period.
Secondary
Number of Participants With Negative Control Outcomes
Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure.
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Negative Control Outcomes | 433934 Participants |
Secondary
Number of Participants With Non-COVID-19 Respiratory Infection
Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription.
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Non-COVID-19 Respiratory Infection | 1869819 Participants |
Secondary
Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset | 1008.21 US Dollars | Standard Deviation 8591.93 |