SARS-CoV-2
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
ModernaTX, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Medically Attended Breakthrough COVID-19 Diagnosis | 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]) | Medically attended breakthrough COVID-19 diagnosis defined as a claim for COVID-19 in any setting (inpatient, outpatient, emergency room, urgent care, etc.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Breakthrough Hospitalization for COVID-19 | 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]) | 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. |
Countries
United States
Outcome results
None listed