A Study to Learn About How Well Yearly Updates to the COVID-19 Vaccine Work to Protect People From COVID-19 and How Much Money People Spend on Healthcare for COVID-19

NCT06923137 | Active Not Recruiting FDA Drug

• 1 other identifier: C4591074
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about how well the yearly updates to the COVID-19 vaccine work in adults (age 18 years and above) with a healthy immune system (the body's cells, tissues and organs that work together to protect your body) and in children (age 6 months to 17 years). This study will use a collection of insurance claims and state vaccine registry data called HealthVerity. All patient names and other identifying information is removed. This study will include children who:

• Are 6 months of age to 17 years of age
• Are enrolled for at least 6 months in a row in a health insurance plan that provides data to HealthVerity
• Are enrolled for at least 6 months in a row in a prescription drug insurance plan that provides data to HealthVerity
• Live in the same US state for 6 months in a row
• Live in a US state that requires COVID-19 vaccine reporting and provides all vaccine history data to HealthVerity
• Do not have mismatches in sex and/or year of birth between any of the available datasets
• Do not have records of having had COVID-19 and/or any COVID-19 vaccine in the 90 days before the start of the study This study will include adults who:
• Are 18 years of age and older
• Are enrolled for at least 12 months in a row in a health insurance plan that provides data to HealthVerity
• Are enrolled for at least 12 months in a row in a prescription drug insurance plan that provides data to HealthVerity
• Have lived in the same US state for at least 12 months
• Live in a US state that requires COVID-19 reporting and provides all vaccine history data to HealthVerity
• Do not have mismatches in sex and/or year of birth between any of the available datasets
• Do not have records of having had COVID-19 and/or any COVID-19 vaccine in the 90 days before the start of the study This study will use the data that has already been collected, and no treatment or vaccine will be given in the study. People who match the information above will be followed in the HealthVerity database for up to 6 months following the first day that a new COVID-19 vaccine is available. This information will be reviewed to see if any of the following happen:
• they had a COVID-19 vaccine
• they're diagnosed with COVID-19 in a doctor's office
• they visit the emergency department for COVID-19
• they visit urgent care for COVID-19
• they are hospitalized for COVID-19 The experiences of people who received a COVID-19 vaccine will be compared to the experiences of people who did not receive the vaccine. This will help to understand how well the Pfizer-BioNTech COVID-19 vaccine works at stopping COVID-19.

Conditions

COVID-19 SARS-CoV-2 Infection; COVID-19; COVID-19 Infection; Coronavirus Disease 2019 (COVID-19); COVID-19 (Coronavirus Disease 2019); COVID-19 Vaccination; COVID-19 Vaccines; SARS-CoV-2 Infection, COVID-19

Keywords

COVID-19; COVID-19 vaccines

Outcome Measures

Primary Outcomes (7)

• COVID-19 outpatient encounter in adults

  Outpatient encounter with ICD-10-CM code: U07.1

  6 months

• COVID-19 inpatient encounter in adults

  Hospitalizations "for COVID-19" defined as those with an inpatient encounter at an acute care facility with ICD-10-CM code U07.1 "COVID-19" that did not have an additional incidental code (for unintentional injury, physical trauma, poisoning, short-stay \[\< 2 days\] childbirth or serious psychiatric admissions), or a U07.1 hospitalization where treatment used solely for COVID-19 (e.g., remdesivir) was identified regardless of accompanying diagnoses. As a sensitivity analysis, the definition will be relaxed to consider any hospitalization with a U07.1 code, without consideration of incidental findings.

  6 months

• COVID-19 emergency department visit in adults

  Emergency department visit with ICD-10-CM code: U07.1

  6 months

• COVID-19 urgent care encounter in adults

  An urgent care encounter with ICD-10-CM code: U07.1 "COVID-19"

  6 months

• COVID-19 critical illness in adults

  ICU admission, mechanical ventilation, and/or inpatient death. If sample size allows, we will evaluate VE against each component separately

  6 months

• Cost associated with healthcare encounter in adults

  Mean (standard deviation) and median (Q1-Q3) among all non-zero costs for each care setting of interest

  6 months

• Length of inpatient stay in adults

  Number of days from admission to discharge expressed as mean (standard deviation) and median (Q1-Q3)

  6 months

Secondary Outcomes (7)

• COVID-19 outpatient encounter in children

  6 months

• COVID-19 inpatient encounter in children

  6 months

• COVID-19 emergency department visit in children

  6 months

• COVID-19 urgent care encounter in children

  6 months

• COVID-19 critical illness in children

  6 months

Study Arms (4)

Vaccinated Adult

Vaccinated with BNT162b2 and at least 18 years of age

Drug: BNT162b2

Unvaccinated Adult

Unvaccinated with BNT162b2 and at least 18 years of age

Drug: BNT162b2

Vaccinated Child

Vaccinated with BNT162b2 and 6 months to under 18 years of age

Drug: BNT162b2

Unvaccinated Child

Unvaccinated with BNT162b2 and 6 months to under 18 years of age

Drug: BNT162b2

Interventions

BNT162b2 DRUG

BNT162b2

Unvaccinated Adult; Unvaccinated Child; Vaccinated Adult; Vaccinated Child

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

At least 6 months of age and vaccinated or unvaccinated with BNT162b2

The youngest possible age for any person in any aim of the study is 6 months old. For objectives pertaining to adults, this protocol will be conducted among persons who have all of the following: * At least one year of continuous medical enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Medical claims are used to measure inpatient, outpatient, emergency department and urgent care encounters. A gap of up to 30 days will be allowed. * At least one year of continuous pharmacy enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Pharmacy claims are used to measure outpatient dispensations of drugs, vaccines, and other biological products. A gap of up to 30 days will be allowed. * At least one year of continuous state residency in a state with mandatory COVID-19 vaccination reporting that contributes the entire state vaccine registry to HealthVerity. * Does not have discrepancies in sex and/or year of birth between any of the available datasets. These are critical covariates in models as they are amongst the most important risk factors for severe disease. * Did not have documented episode of COVID-19 and/or receipt of any COVID-19 vaccine during the 90 days prior to index date. These persons likely have lower risk of vaccination (the study's exposure of interest) as well as temporarily lower risk of COVID-19 (the study's outcome of interest), which would introduce heterogeneity in estimates were they not excluded. For objectives pertaining to pediatrics, this protocol will be conducted among persons who have all of the following: * At least six months of continuous medical enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Medical claims are used to measure inpatient, outpatient, emergency department and urgent care encounters. A gap of up to 30 days will be allowed. * At least six months of continuous pharmacy enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Pharmacy claims are used to measure outpatient dispensations of drugs, vaccines, and other biological products. A gap of up to 30 days will be allowed. * At least six months of continuous state residency in a state with mandatory COVID-19 vaccination reporting that contributes the entire state vaccine registry to HealthVerity. * Does not have discrepancies in sex and/or year of birth between any of the available datasets. These are critical covariates in models as they are amongst the most important risk factors for severe disease. * Did not have documented episode of COVID-19 and/or receipt of any COVID-19 vaccine during the 90 days prior to index date. These persons likely have lower risk of vaccination (the study's exposure of interest) as well as temporarily lower risk of COVID-19 (the study's outcome of interest), which would introduce heterogeneity in estimates were they not excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Publications (1)

• Andersen KM, Ahi T, Mateus JS, Yu T, Zhou A, Lopez SMC, Puzniak L. 2024-2025 BNT162b2 COVID-19 vaccine effectiveness in non-immunocompromised adults: mid-season estimates from vaccine registries in two states linked to administrative claims. Vaccine. 2025 Aug 30;62:127534. doi: 10.1016/j.vaccine.2025.127534. Epub 2025 Jul 24.

  PMID: 40712320 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)