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

Overview

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.

Full Title of Study: “Title Not in Corporate Clinical Trial Registry (CCTR)”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: August 31, 2023

Interventions

• 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.

Arms, Groups and Cohorts

• 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
• 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

Clinical Trial Outcome Measures

Primary Measures

• Number of patients with Post-COVID condition (PCC) defined as a composite of 3 definitions
  • Time Frame: 29-120 days after COVID-19 diagnosis
  • 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.
• Number of patients with an mRNA bivalent vaccination
  • Time Frame: Date of vaccine authorization through a minimum of 8 months
  • Any record of mRNA bivalent vaccination as recorded in the state immunization registry.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Pfizer
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Pfizer CT.gov Call Center, Study Director, Pfizer
• Overall Contact(s)
  • Pfizer CT.gov Call Center, 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com