Comparing mRNA-1273 and Protein-Based NVX-CoV2705 Vaccines for COVID-19 Outcomes in Insured U.S. Adults During 2024-2025

Declarations. Conflict of Interest: Amanda Wilson, Ekkehard Beck, Heather R. Hensler, Nevena Vicic, Keya Joshi, Emily Patry, Linwei Li, Jane Wang, and Chris Clarke are employees of Moderna, Inc. and may hold stock and/or stock options in Moderna, Inc. Ethical Approval: This is a secondary analysis of de-identified data without access to personal identifying information and without direct enrollment of patients (e.g., in contrast to interventional studies or other primary data collection studies requiring patient participation). Thus, informed consent is not applicable. All patient-level and provider-level data within the database contain synthetic identifiers to protect the privacy of patients and data contributors. All study reports will contain aggregated data only that cannot be used to identify patients or physicians. Analysis data sets are Health Insurance Portability and Accountability Act (HIPAA) compliant. Per 45 CFR 46.104 d4, institutional review board (IRB) approval is not required for secondary research, which does not use any identifiable information and if the study team does not have the code key with which the information can be made identifiable. This study is therefore not considered human subjects research and exempt from requiring IRB oversight. For these reasons, we believe that this study qualifies for an exemption from IRB/institutional ethics committee (IEC) review. Exemption determination and HIPAA full waiver of authorization will be sought, and the IRB/IEC letter will be stored in the study file.