Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data

Completed

Conditions: SARS-CoV-2
COVID-19 Vaccines

Interventions: Biological: Vaccination

Registration Number: NCT06199934

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19853610

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated	Vaccination	BNT162b2 recipients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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 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 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 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.
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.
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)
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.