N/A
Completed N=19,853,610
Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
SARS-CoV-2 infection · COVID-19 Vaccines
Source: ClinicalTrials.gov NCT06199934 ↗
Enrolled (actual)
19,853,610
Serious AEs
—
Results posted
Sep 2025
Primary outcomePrimary: Number of Participants COVID-19 Diagnosis — 210902 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants COVID-19 Diagnosis |
210902 | — |
| SECONDARY Number of Participants With an Outpatient Encounter |
130171 | — |
| SECONDARY Number of Participants With an Inpatient Encounter |
11172 | — |
| SECONDARY Number of Participants With Emergency Department Encounter |
28010 | — |
| SECONDARY Number of Participants With COVID-19 Critical Illness |
3905 | — |
| SECONDARY Number of Participants With Non-COVID-19 Respiratory Infection |
1869819 | — |
| SECONDARY Number of Participants With Negative Control Outcomes |
433934 | — |
| SECONDARY Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset |
1008.21 | — |
| SECONDARY Average Length of Stay (LOS) |
6.11 | — |
| SECONDARY Number of Participants With ICU Admission Are Included in This Outcome Measure. |
2864 | — |
| SECONDARY Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV) |
863 | — |
| SECONDARY Number of Participants With Inpatient Mortality |
— | — |
| SECONDARY Number of Participants Who Received Antiviral Treatment |
41774 | — |
| SECONDARY Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset |
9563.85 | — |
| SECONDARY All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset |
10.04 | — |
| SECONDARY Number of Participants With COVID-19-Related Hospitalization |
12129 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06199934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.