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

N/ACompletedNCT06199934

Pfizer19,853,610 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

19,853,610

Conditions

SARS-CoV-2 COVID-19 Vaccines

Interventions

VaccinationBIOLOGICAL

BNT162b2 vaccination

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Global Headquarters

New York, New York, United States

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

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)

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)

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)

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.

Data from ClinicalTrials.gov

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Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)

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)

Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset