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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real-world Comparative Effectiveness of the mRNA-1273 Vaccine vs. BNT162b2 Vaccine Among Immunocompromised Adults in the United States

Conditions
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SARS-CoV-2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Cohort A: mRNA-1273 COVID Vaccine<br>Participants who have received 2 doses of the mRNA-1273 vaccine at least 14 days apart. | |
| Cohort B: BNT1262b2 COVID Vaccine<br>Participants who have received 2 doses of the BNT1262b2 vaccine at least 14 days apart. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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]) |