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Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study

In Taiwan, new H1N1 monovalent vaccines without adjuvant and with MF59® adjuvant were used in the nationwide vaccination campaign beginning on November 1, 2009. From November 2009 through February 2010, the authors identified recipients of H1N1 vaccines who were diagnosed with adverse events of spec...

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Autores principales: Huang, Wan-Ting, Yang, Hsu-Wen, Liao, Tzu-Lin, Wu, Wan-Jen, Yang, Shu-Er, Chih, Yi-Chien, Chuang, Jen-Hsiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3594153/
https://www.ncbi.nlm.nih.gov/pubmed/23536827
http://dx.doi.org/10.1371/journal.pone.0058827
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author Huang, Wan-Ting
Yang, Hsu-Wen
Liao, Tzu-Lin
Wu, Wan-Jen
Yang, Shu-Er
Chih, Yi-Chien
Chuang, Jen-Hsiang
author_facet Huang, Wan-Ting
Yang, Hsu-Wen
Liao, Tzu-Lin
Wu, Wan-Jen
Yang, Shu-Er
Chih, Yi-Chien
Chuang, Jen-Hsiang
author_sort Huang, Wan-Ting
collection PubMed
description In Taiwan, new H1N1 monovalent vaccines without adjuvant and with MF59® adjuvant were used in the nationwide vaccination campaign beginning on November 1, 2009. From November 2009 through February 2010, the authors identified recipients of H1N1 vaccines who were diagnosed with adverse events of special interest (AESIs) in a large-linked safety database, and used the self-controlled case series (SCCS) method to examine the risk of each AESI in the 0–42 days after H1N1 vaccination. Of the 3.5 million doses of H1N1 vaccines administered and captured in the linked database, the SCCS analysis of Guillain-Barré syndrome (GBS) found an incidence rate ratio of 3.81 (95% confidence interval 0.43–33.85) within 0–42 days after nonadjuvanted H1N1 vaccination and no cases after MF59®-adjuvanted H1N1 vaccination. The risks of other AESIs were, in general, not increased in any of the predefined postvaccination risk periods and age groups. The databases and infrastructure created for H1N1 vaccine safety evaluation may serve as a model for safety, effectiveness and coverage studies of licensed vaccines in Taiwan.
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spelling pubmed-35941532013-03-27 Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study Huang, Wan-Ting Yang, Hsu-Wen Liao, Tzu-Lin Wu, Wan-Jen Yang, Shu-Er Chih, Yi-Chien Chuang, Jen-Hsiang PLoS One Research Article In Taiwan, new H1N1 monovalent vaccines without adjuvant and with MF59® adjuvant were used in the nationwide vaccination campaign beginning on November 1, 2009. From November 2009 through February 2010, the authors identified recipients of H1N1 vaccines who were diagnosed with adverse events of special interest (AESIs) in a large-linked safety database, and used the self-controlled case series (SCCS) method to examine the risk of each AESI in the 0–42 days after H1N1 vaccination. Of the 3.5 million doses of H1N1 vaccines administered and captured in the linked database, the SCCS analysis of Guillain-Barré syndrome (GBS) found an incidence rate ratio of 3.81 (95% confidence interval 0.43–33.85) within 0–42 days after nonadjuvanted H1N1 vaccination and no cases after MF59®-adjuvanted H1N1 vaccination. The risks of other AESIs were, in general, not increased in any of the predefined postvaccination risk periods and age groups. The databases and infrastructure created for H1N1 vaccine safety evaluation may serve as a model for safety, effectiveness and coverage studies of licensed vaccines in Taiwan. Public Library of Science 2013-03-11 /pmc/articles/PMC3594153/ /pubmed/23536827 http://dx.doi.org/10.1371/journal.pone.0058827 Text en © 2013 Huang et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Huang, Wan-Ting
Yang, Hsu-Wen
Liao, Tzu-Lin
Wu, Wan-Jen
Yang, Shu-Er
Chih, Yi-Chien
Chuang, Jen-Hsiang
Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study
title Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study
title_full Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study
title_fullStr Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study
title_full_unstemmed Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study
title_short Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study
title_sort safety of pandemic (h1n1) 2009 monovalent vaccines in taiwan: a self-controlled case series study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3594153/
https://www.ncbi.nlm.nih.gov/pubmed/23536827
http://dx.doi.org/10.1371/journal.pone.0058827
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