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:	Wan-Ting Huang, Hsu-Wen Yang, Tzu-Lin Liao, Wan-Jen Wu, Shu-Er Yang, Yi-Chien Chih, Jen-Hsiang Chuang
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/3b28155b52424408830fc1ea2a626873
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spelling	oai:doaj.org-article:3b28155b52424408830fc1ea2a6268732021-11-18T07:53:56ZSafety of pandemic (H1N1) 2009 monovalent vaccines in taiwan: a self-controlled case series study.1932-620310.1371/journal.pone.0058827https://doaj.org/article/3b28155b52424408830fc1ea2a6268732013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23536827/?tool=EBIhttps://doaj.org/toc/1932-6203In 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.Wan-Ting HuangHsu-Wen YangTzu-Lin LiaoWan-Jen WuShu-Er YangYi-Chien ChihJen-Hsiang ChuangPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 3, p e58827 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Wan-Ting Huang Hsu-Wen Yang Tzu-Lin Liao Wan-Jen Wu Shu-Er Yang Yi-Chien Chih Jen-Hsiang Chuang Safety of pandemic (H1N1) 2009 monovalent vaccines in taiwan: a self-controlled case series study.
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.
format	article
author	Wan-Ting Huang Hsu-Wen Yang Tzu-Lin Liao Wan-Jen Wu Shu-Er Yang Yi-Chien Chih Jen-Hsiang Chuang
author_facet	Wan-Ting Huang Hsu-Wen Yang Tzu-Lin Liao Wan-Jen Wu Shu-Er Yang Yi-Chien Chih Jen-Hsiang Chuang
author_sort	Wan-Ting Huang
title	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_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_sort	safety of pandemic (h1n1) 2009 monovalent vaccines in taiwan: a self-controlled case series study.
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/3b28155b52424408830fc1ea2a626873
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Safety of pandemic (H1N1) 2009 monovalent vaccines in taiwan: a self-controlled case series study.

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