tetano
Editor, Senior Moderator
Eurosurveillance, Volume 19, Issue 36, 11 September 2014
Surveillance and outbreak reports
Did narcolepsy occur following administration of AS03-adjuvanted A(H1N1) pandemic vaccine in Ontario, Canada? A review of post-marketing safety surveillance data
T Harris ()1, K Wong1, L Stanford2, J Fediurek1, N Crowcroft1,3,4, S L Deeks1,3
Public Health Ontario, Toronto, Ontario, Canada
Simcoe-Muskoka District Health Unit, Ontario, Canada
Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
Citation style for this article: Harris T, Wong K, Stanford L, Fediurek J, Crowcroft N, Deeks SL. Did narcolepsy occur following administration of AS03-adjuvanted A(H1N1) pandemic vaccine in Ontario, Canada? A review of post-marketing safety surveillance data . Euro Surveill. 2014;19(36)
ii=20900. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20900
Date of submission: 09 October 2013
A vaccine safety signal and association between new onset of narcolepsy and AS03-adjuvanted pandemic influenza A(H1N1) vaccine (Pandemrix, GlaxoSmithKline) in children and young adults has been reported in several European countries. In Ontario, Canada, AS03-adjuvanted pandemic A(H1N1) vaccine (Arepanrix, GlaxoSmithKline) was the primary vaccine administered in 2009/10, with 4.8 million doses distributed. We assessed post-marketing safety surveillance data by extracting adverse events following immunisation (AEFIs) associated with this vaccine from the integrated Public Health Information System. Reports were screened for key terms related to narcolepsy and further limited to children and young adults four to 29 years of age. Of 1,604 AEFIs reported in Ontario, 53 reports met the search criteria. Individual assessment by a nurse consultant for additional context suggestive of narcolepsy yielded five reports for secondary medical review. None of the five reports proved consistent with a possible narcolepsy diagnosis based on the available information. We present the first post-marketing assessment from Canada of narcolepsy reports following receipt of Arepanix. Continued investigation of differences between Arepanrix and Pandemrix and subsequent risk of narcolepsy is indicated. In light of the limitations of passive surveillance to detect a signal in this instance, validation using other data sources is prudent.
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20900
Surveillance and outbreak reports
Did narcolepsy occur following administration of AS03-adjuvanted A(H1N1) pandemic vaccine in Ontario, Canada? A review of post-marketing safety surveillance data
T Harris ()1, K Wong1, L Stanford2, J Fediurek1, N Crowcroft1,3,4, S L Deeks1,3
Public Health Ontario, Toronto, Ontario, Canada
Simcoe-Muskoka District Health Unit, Ontario, Canada
Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
Citation style for this article: Harris T, Wong K, Stanford L, Fediurek J, Crowcroft N, Deeks SL. Did narcolepsy occur following administration of AS03-adjuvanted A(H1N1) pandemic vaccine in Ontario, Canada? A review of post-marketing safety surveillance data . Euro Surveill. 2014;19(36)
ii=20900. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20900Date of submission: 09 October 2013
A vaccine safety signal and association between new onset of narcolepsy and AS03-adjuvanted pandemic influenza A(H1N1) vaccine (Pandemrix, GlaxoSmithKline) in children and young adults has been reported in several European countries. In Ontario, Canada, AS03-adjuvanted pandemic A(H1N1) vaccine (Arepanrix, GlaxoSmithKline) was the primary vaccine administered in 2009/10, with 4.8 million doses distributed. We assessed post-marketing safety surveillance data by extracting adverse events following immunisation (AEFIs) associated with this vaccine from the integrated Public Health Information System. Reports were screened for key terms related to narcolepsy and further limited to children and young adults four to 29 years of age. Of 1,604 AEFIs reported in Ontario, 53 reports met the search criteria. Individual assessment by a nurse consultant for additional context suggestive of narcolepsy yielded five reports for secondary medical review. None of the five reports proved consistent with a possible narcolepsy diagnosis based on the available information. We present the first post-marketing assessment from Canada of narcolepsy reports following receipt of Arepanix. Continued investigation of differences between Arepanrix and Pandemrix and subsequent risk of narcolepsy is indicated. In light of the limitations of passive surveillance to detect a signal in this instance, validation using other data sources is prudent.
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20900