Document is current

Article History

Received: 23 July 2025

Accepted: 3 September 2025

First Online: 3 October 2025

Declarations

:

: Alicia Stein, Ian McGovern and Mendel Haag are employees of CSL Seqirus and own shares of stock/stock options in CSL. Anusorn Thanataveerat, Kimberly McDermott, Alex Dean, Stephanie Wall, and Cory Pack are employees of Veradigm and, as such, were contracted by CSL Seqirus to complete this analysis. Sheena Sullivan has received consulting honoraria from CSL Seqirus, Novavax, and Astra Zeneca, and has participated in advisory boards for CSL Seqirus, Pfizer, Moderna, Sanofi and GSK.

: The study was conducted using a database linking de-identified electronic medical records with medical and pharmacy claims data. The database operates under a certification of statistical de-identification by a third-party HIPAA Expert Determination provider. The certification process ensures that users only have access to de-identified data and cannot pose a risk to re-identification. Since the database is HIPAA-certified based on a validated independent assessment and users receive unidentifiable/de-identified or coded data (with identifiers kept separately), the study does not fall within the regulatory definition of research involving human participants as outlined by the Code of Federal Regulations (policy 46.102(f)). The study is therefore exempt from institutional review board approval, and informed consent was not needed. The study was designed, implemented, and reported in accordance with the ISPE Guidelines for Good Pharmacoepidemiological Practice, with applicable local regulations, and with the ethical principles laid down in the Declaration of Helsinki of 1964 and its later amendments.