BACKGROUNDAnaphylaxis is a life-threatening event. The aim of this study was to estimate the annual frequency of anaphylaxis after immunization in individuals younger than 18 years in Germany leading to hospitalization.METHODSAll suspected cases of postvaccination anaphylaxis involving individuals aged 0-17 years reported to the German surveillance unit for rare pediatric diseases (Erhebungseinheit für seltene pädiatrische Erkrankungen in Deutschland) from June 2008 through May 2010, and all suspected cases of anaphylaxis as an adverse event following immunization in the same age group reported to the Paul-Ehrlich-Institut during the observational period were classified according to the Brighton collaboration case definition. Only hospitalized cases of anaphylaxis fulfilling Brighton collaboration case definition level 1-3 criteria were eligible. Estimates for the annual frequency were calculated by using capture-recapture methods.RESULTSA total of 22 reports were eligible. Median age of the affected individuals (13 males, 9 females) was 7.0 years (range: 2 months to 17 years). Anaphylaxis occurred most frequently after administration of AS03 adjuvanted A/H1N1 pandemic influenza vaccine (n = 8). The annual frequency of anaphylaxis after vaccination (excluding pandemic influenza vaccine as well as monovalent measles and rubella vaccines) was estimated to be 6.8 (95% confidence interval: 6.1-10.9). The estimated incidence of anaphylaxis after administration of specific vaccines ranged from 0.4 to 127.6 cases per 1,000,000 doses administered.CONCLUSIONSThis study confirms that anaphylaxis after immunization in children and adolescents is a rare event. AS03 adjuvanted A/H1N1 pandemic influenza vaccine seems to be associated with a higher risk of anaphylaxis when compared with other vaccines.

01 Oct 2015·SleepQ2 · MEDICINE

Incidence of Narcolepsy in Germany

Q2 · MEDICINE

Article

Author: Mayer, Geert ; Schmidtmann, Irene ; Keller-Stanislawski, Brigitte ; Oberle, Doris ; Drechsel-Bäuerle, Ursula

STUDY OBJECTIVESFollowing the 2009 pandemic, reports of an association between an AS03 adjuvanted H1N1 pandemic influenza vaccine and narcolepsy were published. Besides determining background incidence rates for narcolepsy in Germany this study aimed at investigating whether there was a change in incidence rates of narcolepsy between the pre-pandemic, pandemic, and the post-pandemic period on the population level.DESIGNRetrospective epidemiological study on the incidence of narcolepsy with additional capture-recapture analysis.SETTINGGerman sleep centers.PATIENTS OR PARTICIPANTSEligible were patients with an initial diagnosis of narcolepsy (ICD10 Code G47.4) within the period from January 1, 2007 to December 31, 2011.INTERVENTIONSNone; observational study.MEASUREMENTS AND RESULTSA total of 342 sleep centers were invited to participate in the study. Adequate and suitable data were provided by 233 sleep centers (68.1%). A total of 1,198 patients with an initial diagnosis of narcolepsy within the observed period were included, of whom 106 (8.8%) were children and adolescents under the age of 18 years and 1,092 (91.2%) were adults. In children and adolescents, the age-standardized adjusted incidence rate significantly increased from 0.14/100,000 person-years in the pre-pandemic period to 0.50/100,000 person-years in the post-pandemic period (incidence density ratio, IDR 3.57; 95% CI 1.94-7.00). In adults, no significant change was detectable. This increase started in spring 2009.CONCLUSIONSFor the years 2007-2011, valid estimates for the incidence of narcolepsy in Germany were provided. In individuals under 18, the incidence rates continuously increased from spring 2009.

100 Deals associated with Vero cell-derived H1N1 pandemic influenza vaccine(Resilience)

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Indication	Highest Phase	Country/Location	Organization	Date
influenza A subtype H1N1 infection	Phase 2	US	Resilience Government Services, Inc.	07 Sep 2012

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