A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults

ModernaTX, Inc.124,879 enrolled

Overview

The goal of this study is to compare real-world effectiveness of the mRNA-1273 vaccine versus the BNT162b2 vaccine on medically attended COVID-19 and COVID-19 hospitalizations among fully vaccinated immunocompromise participants.

This observational retrospective comparative effectiveness cohort study will use the HealthVerity aggregated medical and pharmacy claims database. HealthVerity data elements include provider-submitted claims, adjudicated insurance claims, and pharmacy billing manager claims submissions. Hospitalizations are included in the data at a summary level.

Study Type

OBSERVATIONAL

Enrollment

124,879

Conditions

SARS-CoV-2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fully vaccinated with a currently US authorized COVID-19 vaccine: * 2 doses of mRNA-1273 (minimum 14 days between doses) * 2 doses of BNT1262b2 (minimum 14 days between doses) * Continuous enrollment in medical \& pharmacy plan for at least 365 days prior to index/Cohort entry date (CED) * Identified as immunocompromised via at least 1 of the following criteria at index/CED * Evidence of blood or stem cell transplant in 2 years prior to index/CED * Any history of organ transplant and taking immunosuppressive therapy within the 60 days prior to index/CED * Evidence of active cancer treatment in the 180 days prior to index/CED with an active cancer diagnosis in the 365 days prior to treatment * Any prior history of a primary immunodeficiency disorder (for example, for conditions such as DiGeorge syndrome and Wiskott-Aldrich syndrome) * Any history of an HIV diagnosis code prior to index/CED * A fill for an immunosuppressive therapy in the 60 days prior to index/CED Exclusion Criteria: * Prior COVID-19 infection (any history prior to index/CED through day 13 post-completion of vaccine regimen) identified via the following diagnosis codes on an inpatient or outpatient claim: * U07.1: "COVID-19, virus identified" * J12.82: "Pneumonia due to COVID-19" * Z86.16: "Personal history of COVID-19" * The following diagnosis codes were utilized early in the pandemic. Exclusion will be applied March 1, 2020 through day 13 post-completion of vaccine regimen: * J12.89: "Other viral pneumonia" * J20.8: "Acute bronchitis due to other specified organisms" * J40: "Bronchitis, not specified as acute or chronic" * J22: "Unspecified acute lower respiratory infection" * J98.8: "Other specified respiratory disorders" * J80: "Acute respiratory distress syndrome" * Prior receipt of a heterologous COVID-19 vaccine (relative to the COVID-19 vaccine identified at index/CED) in the 365 days prior to index/CED through 13 days post-completion of vaccine regimen * Receipt of an additional dose of homologous COVID-19 vaccine between index/CED and 13 days post-completion of vaccine regimen * Missing or unknown gender on index/CED

Locations (1)

Aetion Inc.

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants with Medically Attended Breakthrough COVID-19 Diagnosis

Medically attended breakthrough COVID-19 diagnosis defined as a claim for COVID-19 in any setting (inpatient, outpatient, emergency room, urgent care, etc.).

Time frame: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])

Secondary Outcomes

Number of Participants with Breakthrough Hospitalization for COVID-19

Breakthrough hospitalization for COVID-19 defined as a hospital stay for COVID-19 listed as the primary diagnosis or within 21 days prior to hospital admission.

Time frame: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.