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Risk of Narcolepsy after AS03 Adjuvanted Pandemic A/H1N1 2009 Influenza Vaccine in Adults: A Case-Coverage Study in England

tetano

Editor, Senior Moderator
Sleep. 2016 Feb 1. pii: sp-00484-15. [Epub ahead of print]
[h=1]Risk of Narcolepsy after AS03 Adjuvanted Pandemic A/H1N1 2009 Influenza Vaccine in Adults: A Case-Coverage Study in England.[/h] Stowe J, Miller E, Andrews N, Kosky C, Leschziner G, Shneerson JM, Hall A, Eriksson S, Reading P, Dennis G, Donegan K.
[h=3]Abstract[/h] [h=4]STUDY OBJECTIVES:[/h] An increased risk of narcolepsy has been observed in children following ASO3-adjuvanted pandemic A/H1N1 2009 (Pandemrix) vaccine. We investigated whether this risk extends to adults in England.
[h=4]METHODS:[/h] Six adult sleep centers in England were visited between November 2012 and February 2014 and vaccination/clinical histories obtained from general practitioners. Suspected narcolepsy cases aged older than 17 y were selected. The risk of narcolepsy following Pandemrix was calculated using cases diagnosed by the time of the center visits and those with a diagnosis by November 30, 2011 after which there was increased awareness of the risk in children. The odds of vaccination in cases and in matched population data were compared using a case-coverage design.
[h=4]RESULTS:[/h] Of 1,446 possible cases identified, most had onset before 2009 or were clearly not narcolepsy. Of the 60 remaining cases, 20 were excluded after expert review, leaving 40 cases with narcolepsy; 5 had received Pandemrix between 3 and 18 mo before onset. All the vaccinated cases had cataplexy, two received a diagnosis by November 2011 and two were aged 40 y or older. The odds ratio for vaccination in cases compared to the population was 4.24 (95% confidence interval 1.45-12.38) using all cases and 9.06 (1.90-43.17) using cases with a diagnosis by November 2011, giving an attributable risk of 0.59 cases per 100,000 doses.
[h=4]CONCLUSIONS:[/h] We found a significantly increased risk of narcolepsy in adults following Pandemrix vaccination in England. The risk was lower than that seen in children using a similar study design.
Copyright ? 2016 Associated Professional Sleep Societies, LLC. All rights reserved.


[h=4]KEYWORDS:[/h] Pandemrix; adult; case-coverage; narcolepsy; vaccination

PMID: 26856903 [PubMed - as supplied by publisher]
 
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