Effectiveness and Use of COVID-19 Vaccines Using Information From the California State Vaccine Registry

Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data

This study aims to use vaccination information from the California Immunization Registry linked with HealthVerity insurance claims for patients residing in California for the following:

• to measure effectiveness of the Pfizer-BioNTech bivalent booster against post-COVID conditions.
• to understand characteristics of patients who are receiving COVID-19 vaccines.

All patients who have been de-identified in the HealthVerity database are eligible to be included for both aims of this study.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; SARS-CoV-2; Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine

• Study Type: Observational
• Enrollment (Estimated): 999

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Recruiting
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be sourced from HealthVerity and includes patients who are enrolled in the claims database as well as recorded in the State of California's deidentified vaccine registry. Patients who will be followed for the PCC endpoint must be eligible to receive the bivalent booster during the study period.

Description

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Include patients whose claims records and vaccine registry data are both available in the HealthVerity databases

2. Include patients who are eligible to receive the bivalent booster during the study period

   • ≥2 monovalent doses have been received
   • ≥2 months have elapsed since the most recent prior monovalent dose.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Exclude patients with a PCC episode prior to being eligible for the bivalent mRNA COVID-19 vaccine booster

2. Receipt of the bivalent mRNA COVID-19 vaccine booster prior to authorization

   1. Exclude patients ≥12 years old who received a bivalent mRNA COVID-19 vaccine booster prior to 31 August 2022
   2. Exclude patients 5-11 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 12 October 2022
   3. Exclude patients 6 months to 4 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 08 December 2022.

3. Receipt of the bivalent mRNA COVID-19 vaccine booster prior to being eligible

   a. Exclude patients who received the bivalent mRNA COVID-19 vaccine booster <2 months since receipt of the most recent prior monovalent dose.

4. Exclude patients who have had >1 bivalent mRNA COVID-19 vaccine dose
5. Exclude patients who have had ≥5 monovalent mRNA COVID-19 vaccine doses
6. Exclude patients who have had any non-mRNA COVID-19 vaccine
7. Exclude patients who had a Moderna COVID-19 Vaccine, Bivalent booster
8. Exclude patients who are immunocompromised or pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Boosted with Pfizer-BioNTech COVID-19 bivalent mRNA vaccine; Patient identified in the vaccine registry having a single dose Pfizer-BioNTech COVID-19 bivalent mRNA vaccine after completion of the primary series	Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine; Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.; Other Names: Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Not Boosted with Pfizer-BioNTech COVID-19 bivalent mRNA vaccine; Patient not located in the vaccine registry having a single dose Pfizer-BioNTech COVID-19 bivalent mRNA vaccine after completion of the primary series

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Post-COVID condition (PCC) defined as a composite of 3 definitions	A diagnosis of PCC using the ICD-10-CM code OR new onset of specific conditions (Cardiovascular, Hemolytic and Vascular, Pulmonary, Renal, gastrointestinal, Neurologic, Endocrine or Mental health) OR new onset of any commonly experienced diagnosis or symptom.	29-120 days after COVID-19 diagnosis
Number of patients with an mRNA bivalent vaccination	Any record of mRNA bivalent vaccination as recorded in the state immunization registry.	Date of vaccine authorization through a minimum of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with PCC defined using the ICD-10-CM code		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a new specific condition	A new onset of any of the following specific conditions (Cardiovascular, Hemolytic and Vascular, Pulmonary, Renal, gastrointestinal, Neurologic, Endocrine or Mental health)	29-120 days after COVID-19 diagnosis
Number of patients with a new PCC defined with commonly experienced diagnoses or symptoms		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a new diagnosis for a cardiovascular condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a new diagnosis for a hemolytic/vascular condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a diagnosis for a new pulmonary condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a diagnosis for a new musculoskeletal condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a new diagnosis for a renal condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a diagnosis for a new gastrointestinal condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a diagnosis for a new neurologic condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a diagnosis for a new endocrine condition		29-120 days after COVID-19 diagnosis
Number of patients with PCC defined with a diagnosis for a new mental health condition		29-120 days after COVID-19 diagnosis

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19 Vaccines; COVID-19 Drug Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: C4591059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No