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Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
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 da...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019152/ https://www.ncbi.nlm.nih.gov/pubmed/26572776 http://dx.doi.org/10.1002/pds.3908 |
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author | Yih, Weiling Katherine Kulldorff, Martin Sandhu, Sukhminder K. Zichittella, Lauren Maro, Judith C. Cole, David V. Jin, Robert Kawai, Alison Tse Baker, Meghan A. Liu, Chunfu McMahill‐Walraven, Cheryl N. Selvan, Mano S. Platt, Richard Nguyen, Michael D. Lee, Grace M. |
author_facet | Yih, Weiling Katherine Kulldorff, Martin Sandhu, Sukhminder K. Zichittella, Lauren Maro, Judith C. Cole, David V. Jin, Robert Kawai, Alison Tse Baker, Meghan A. Liu, Chunfu McMahill‐Walraven, Cheryl N. Selvan, Mano S. Platt, Richard Nguyen, Michael D. Lee, Grace M. |
author_sort | Yih, Weiling Katherine |
collection | PubMed |
description | 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 ≤4 years 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 6 weeks of the last care‐date in the cumulative dataset. A total of 6 682 336 doses of IIV and 782 125 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. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. |
format | Online Article Text |
id | pubmed-5019152 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50191522016-09-23 Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System Yih, Weiling Katherine Kulldorff, Martin Sandhu, Sukhminder K. Zichittella, Lauren Maro, Judith C. Cole, David V. Jin, Robert Kawai, Alison Tse Baker, Meghan A. Liu, Chunfu McMahill‐Walraven, Cheryl N. Selvan, Mano S. Platt, Richard Nguyen, Michael D. Lee, Grace M. Pharmacoepidemiol Drug Saf Original Reports 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 ≤4 years 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 6 weeks of the last care‐date in the cumulative dataset. A total of 6 682 336 doses of IIV and 782 125 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. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. John Wiley and Sons Inc. 2015-11-17 2016-05 /pmc/articles/PMC5019152/ /pubmed/26572776 http://dx.doi.org/10.1002/pds.3908 Text en © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Reports Yih, Weiling Katherine Kulldorff, Martin Sandhu, Sukhminder K. Zichittella, Lauren Maro, Judith C. Cole, David V. Jin, Robert Kawai, Alison Tse Baker, Meghan A. Liu, Chunfu McMahill‐Walraven, Cheryl N. Selvan, Mano S. Platt, Richard Nguyen, Michael D. Lee, Grace M. Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System |
title | Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
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title_full | Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
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title_fullStr | Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
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title_full_unstemmed | Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
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title_short | Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
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title_sort | prospective influenza vaccine safety surveillance using fresh data in the sentinel system |
topic | Original Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019152/ https://www.ncbi.nlm.nih.gov/pubmed/26572776 http://dx.doi.org/10.1002/pds.3908 |
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