Trial Outcomes & Findings for Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data (NCT NCT06199934)
NCT ID: NCT06199934
Last Updated: 2025-09-10
Results Overview
Number of participants diagnosed with COVID-19 were reported in this outcome measure.
COMPLETED
19853610 participants
From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
2025-09-10
Participant Flow
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.
A total of 19853610 participants were enrolled this study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
19853610
|
|
Overall Study
COMPLETED
|
19853610
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
Baseline characteristics by cohort
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Age, Continuous
|
38.4 Years
STANDARD_DEVIATION 22.03 • n=19702014 Participants • Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.
|
|
Sex/Gender, Customized
Female
|
10455294 Participants
n=19853610 Participants
|
|
Sex/Gender, Customized
Male
|
9340840 Participants
n=19853610 Participants
|
|
Sex/Gender, Customized
Unknown/missing
|
57476 Participants
n=19853610 Participants
|
PRIMARY outcome
Timeframe: 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.
Number of participants diagnosed with COVID-19 were reported in this outcome measure.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants COVID-19 Diagnosis
|
210902 Participants
|
SECONDARY outcome
Timeframe: 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.
Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With an Outpatient Encounter
|
130171 Participants
|
SECONDARY outcome
Timeframe: 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.
Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With an Inpatient Encounter
|
11172 Participants
|
SECONDARY outcome
Timeframe: 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.
Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With Emergency Department Encounter
|
28010 Participants
|
SECONDARY outcome
Timeframe: 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.
COVID-19 critical illness was defined as intensive care unit \[ICU\] admission, mechanical ventilation, or inpatient death.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With COVID-19 Critical Illness
|
3905 Participants
|
SECONDARY outcome
Timeframe: 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.
Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With Non-COVID-19 Respiratory Infection
|
1869819 Participants
|
SECONDARY outcome
Timeframe: 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.
Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With Negative Control Outcomes
|
433934 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset
|
1008.21 US Dollars
Standard Deviation 8591.93
|
SECONDARY outcome
Timeframe: 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.
Average length of stay was defined as date of service end minus date of service start.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Average Length of Stay (LOS)
|
6.11 Days
Standard Deviation 7.99
|
SECONDARY outcome
Timeframe: 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.
Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With ICU Admission Are Included in This Outcome Measure.
|
2864 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV)
|
863 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Number of participants who received antiviral COVID treatment is reported.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants Who Received Antiviral Treatment
|
41774 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset
|
9563.85 US Dollars
Standard Deviation 134821.30
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
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 outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants
n=19853610 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.
|
|---|---|
|
Number of Participants With COVID-19-Related Hospitalization
|
12129 Participants
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER