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

Study Overview
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Brief Summary
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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.

Official Title
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Vaccine Registry Tokenization for Researching Effectiveness and Uptake of COVID-19 Vaccines in the State of California

Conditions
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SARS-CoV-2, COVID-19, Post-Acute COVID-19 Syndrome

Intervention / Treatment
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* Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Include patients whose claims records and vaccine registry data are both available in the HealthVerity databases 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: Exclude patients with a PCC episode prior to being eligible for the bivalent mRNA COVID-19 vaccine booster Receipt of the bivalent mRNA COVID-19 vaccine booster prior to authorization Exclude patients ≥12 years old who received a bivalent mRNA COVID-19 vaccine booster prior to 31 August 2022 Exclude patients 5-11 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 12 October 2022 Exclude patients 6 months to 4 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 08 December 2022. 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. Exclude patients who have had >1 bivalent mRNA COVID-19 vaccine dose Exclude patients who have had ≥5 monovalent mRNA COVID-19 vaccine doses Exclude patients who have had any non-mRNA COVID-19 vaccine Exclude patients who had a Moderna COVID-19 Vaccine, Bivalent booster Exclude patients who are immunocompromised or pregnant.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Boosted with Pfizer-BioNTech COVID-19 bivalent mRNA vaccine<br>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<br>* 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.<br>* Other names: Pfizer-BioNTech COVID-19 Vaccine, Bivalent;|
| Not Boosted with Pfizer-BioNTech COVID-19 bivalent mRNA vaccine<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Vaccines, COVID-19 Drug Treatment