Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System

Weiling Katherine Yih*, Martin Kulldorff, Sukhminder K. Sandhu, Lauren Zichittella, Judith C. Maro, David V. Cole, Robert Jin, Alison Tse Kawai, Meghan A. Baker, Chunfu Liu, Cheryl N. Mcmahill-Walraven, Mano S. Selvan, Richard Platt, Michael D. Nguyen, Grace M. Lee

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

21 Citations (Scopus)

Abstract

Purpose: To develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in the Sentinel System (formerly the Mini-Sentinel Pilot), a Food and Drug Administration-sponsored national surveillance system that typically relies on data that are mature, settled, and updated quarterly. Methods: Three Data Partners provided their earliest available ("fresh") cumulative claims data on influenza vaccination and health outcomes 3-4 times on a staggered basis during the 2013-2014 influenza season, collectively producing 10 data updates. We monitored anaphylaxis in the entire population using a cohort design and seizures in children ≤4years of age using both a self-controlled risk interval design (primary) and a cohort design (secondary). After each data update, we conducted sequential analysis for inactivated (IIV) and live (LAIV) influenza vaccines using the Maximized Sequential Probability Ratio Test, adjusting for data-lag. Results: Most of the 10 sequential analyses were conducted within 6weeks of the last care-date in the cumulative dataset. A total of 6682336 doses of IIV and 782125 doses of LAIV were captured. The primary analyses did not identify any statistical signals following IIV or LAIV. In secondary analysis, the risk of seizures was higher following concomitant IIV and PCV13 than historically after IIV in 6- to 23-month-olds (relative risk=2.7), which requires further investigation. Conclusions: The Sentinel System can implement a sequential analysis system that uses fresh data for medical product safety surveillance. Active surveillance using sequential analysis of fresh data holds promise for detecting clinically significant health risks early. Limitations of employing fresh data for surveillance include cost and the need for careful scrutiny of signals.

Original languageEnglish
Pages (from-to)481-492
Number of pages12
JournalPharmacoepidemiology and Drug Safety
Volume25
Issue number5
DOIs
Publication statusPublished - 1 May 2016
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2016 John Wiley & Sons, Ltd.

Keywords

  • Epidemiologic monitoring
  • Influenza vaccines
  • Pharmacoepidemiology
  • Postmarketing product surveillance
  • Research design
  • Sequential analysis
  • Vaccine safety

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