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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2

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.

• Study Type: Observational
• Enrollment (Actual): 124879

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Aetion Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from HealthVerity's aggregated medical and pharmacy claims database that represents healthcare utilization for participants between 01 December 2018 and 10 January 2022.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort A: mRNA-1273 COVID Vaccine; Participants who have received 2 doses of the mRNA-1273 vaccine at least 14 days apart.
Cohort B: BNT1262b2 COVID Vaccine; Participants who have received 2 doses of the BNT1262b2 vaccine at least 14 days apart.

What is the study measuring?

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])

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Publications and helpful links

General Publications

• Mues KE, Kirk B, Patel DA, Gelman A, Chavers LS, Talarico CA, Esposito DB, Martin D, Mansi J, Chen X, Gatto NM, Van de Velde N. Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults identified in administrative claims data in the United States. Vaccine. 2022 Nov 8;40(47):6730-6739. doi: 10.1016/j.vaccine.2022.09.025. Epub 2022 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): February 4, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: mRNA-1273-P913