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Activity Number: 405 - Statistical Issues Specific to Therapeutic Areas
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #306612
Title: Characteristics of Meta-Analyzes Used for Assessment of Vaccine Safety
Author(s): Rositsa Dimova*
Companies: FDA
Keywords: meta-analysis; safety; vaccines; systematic review

Meta-analyses combine evidence from relevant studies or data sources, in order to make inference regarding a population of interest. Vaccines’ safety data are routinely collected during the pre-market clinical development stage for characterization of their risk profile for benefit-risk evaluation purposes. Post-approval, safety data are collected for surveillance purposes, or to study suspected associations between the use of a specific vaccine product and adverse events. Meta-analysis is especially useful for evaluation of safety events, since most severe adverse events are usually rare, and the individual studies have limited power to detect an increase in safety risk. In November 2018, FDA released a Draft Guidance for Industry “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry”. In order to gain a perspective on the current state of the utilization of the technique of meta-analysis for evaluation of post-market vaccine safety, we will present the results of a systematic review, that we conducted, that assesses published meta-analysis papers which evaluate vaccine safety.

Authors who are presenting talks have a * after their name.

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