NCT06199934

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

Completed Results posted Last updated 10 September 2025

What this trial tests

trial testing Vaccination in SARS-CoV-2 in 19,853,610 participants. Completed in 31 July 2024.

Timeline

11 September 2023

Primary endpoint
31 July 2024

31 July 2024

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	19,853,610
Start date	11 September 2023
Primary completion	31 July 2024
Estimated completion	31 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Vaccination (vaccination) — full drug profile →

Conditions studied

• SARS-CoV-2 — all drugs for SARS-CoV-2 →
• COVID-19 Vaccines — all drugs for COVID-19 Vaccines →

Sponsor

Pfizer — full company profile →

Who can join

Eligibility, any sex, with SARS-CoV-2 or COVID-19 Vaccines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants COVID-19 Diagnosis Primary · 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.

Group	Value	95% CI
All Participants	210902

Number of Participants With an Outpatient Encounter Secondary · 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.

Group	Value	95% CI
All Participants	130171

Number of Participants With an Inpatient Encounter Secondary · 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.

Group	Value	95% CI
All Participants	11172

Number of Participants With Emergency Department Encounter Secondary · 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.

Group	Value	95% CI
All Participants	28010

Number of Participants With COVID-19 Critical Illness Secondary · 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.

Group	Value	95% CI
All Participants	3905

Number of Participants With Non-COVID-19 Respiratory Infection Secondary · 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.

Group	Value	95% CI
All Participants	1869819

Number of Participants With Negative Control Outcomes Secondary · 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.

Group	Value	95% CI
All Participants	433934

Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset Secondary · From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

Group	Value	95% CI
All Participants	1008.21	± 8591.93

Average Length of Stay (LOS) Secondary · 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.

Group	Value	95% CI
All Participants	6.11	± 7.99

Number of Participants With ICU Admission Are Included in This Outcome Measure. Secondary · 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.

Group	Value	95% CI
All Participants	2864

Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV) Secondary · From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)

Group	Value	95% CI
All Participants	863

Number of Participants Who Received Antiviral Treatment Secondary · 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.

Group	Value	95% CI
All Participants	41774

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of BNT162b2 XBB.1.5 vaccine in immunocompetent adults using tokenization in two U.S. states.
   Andersen KM, Allen KE, Nepal RM, Mateus JS, et al · · 2025 · cited 8× · PMID 39987879 · DOI 10.1016/j.vaccine.2025.126881
2. BNT162b2 XBB.1.5-Adapted Single Dose Vaccine Uptake and Effectiveness in Children Aged 5-17 Years Using Linked Claims and Vaccine Registries in California and Louisiana.
   Andersen KM, McColgan MD, Mateus JS, Yu T, et al · · 2025 · PMID 40818804 · DOI 10.1016/j.jpeds.2025.114778