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Abstract Details
Challenges in Phase 4 post-licensure safety studies using real world data in the United States: Hepatitis B vaccine example
Vaccine X. 2021 Jun 11;8:100101. doi: 10.1016/j.jvacx.2021.100101. eCollection 2021 Aug.
Katia Bruxvoort1, Lina S Sy1, Bradley K Ackerson1, Jeff Slezak1, Lei Qian1, William Towner1, Kristi Reynolds1, Zendi Solano1, Cheryl M Carlson1, Steven J Jacobsen1
Author information
1Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Abstract
Post-licensure vaccine safety studies are essential to identify adverse events that may not have been detected in pre-licensure clinical trials and to address questions that arose during the pre-licensure phase. These studies are increasingly conducted using real-world data collected as part of routine health care delivery. However, design of post-licensure vaccine safety studies involves many pragmatic and scientific decisions, which must be made while balancing diverse stakeholder opinions. Challenges include selecting exposure and comparison groups, deciding on the most appropriate outcome, determining sample size and length of follow-up time, and other analytic considerations. As an example of this process and to inform other post-licensure vaccine safety studies in real-world settings, we discuss our experience with design of an FDA-required Phase 4 post-licensure safety study of a hepatitis B vaccine in a large integrated health care organization in the United States.