Delving into the Latest Updates on Vero cell-derived H1N1 pandemic influenza vaccine(Resilience) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Mechanism-

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

influenza A subtype H1N1 infection

Inactive Indication-

Originator Organization

Resilience Government Services, Inc.

Active Organization

Resilience Government Services, Inc.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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All 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.

RESULTS:

A 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.

CONCLUSIONS:

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

STUDY OBJECTIVES:

Following 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.

DESIGN:

Retrospective epidemiological study on the incidence of narcolepsy with additional capture-recapture analysis.

SETTING:

German sleep centers.

PATIENTS OR PARTICIPANTS:

Eligible were patients with an initial diagnosis of narcolepsy (ICD10 Code G47.4) within the period from January 1, 2007 to December 31, 2011.

INTERVENTIONS:

None; observational study.

MEASUREMENTS AND RESULTS:

A 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.

CONCLUSIONS:

For 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.

23 May 2011·VACCINE

Evaluation of the implementation of the H1N1 pandemic influenza vaccine in local health departments (LHDs) in North Carolina.

Article

Author: Horney, Jennifer ; Rosselli, Richard ; Davis, Sarah E H ; DiBiase, Lauren M

INTRODUCTION:

Effective conduct of vaccination campaigns by public health authorities can reduce morbidity and mortality associated with influenza. The emergence of the pandemic H1N1 influenza in April 2009 resulted in an unprecedented vaccination campaign in the US during the 2009-2010 influenza season. The variety of methods local health departments (LHDs) utilized to cope with a mismatch between public demand and supply and ever-changing guidelines have gone unexamined thus far. The purpose of this research is to identify and share lessons learned related to H1N1 influenza vaccination activities at LHDs.

METHODS:

In April 2010, a comprehensive survey was developed to evaluate 2009-10 LHD H1N1 vaccination practices and document lessons learned. A stratified random sample was selected from NC's 85 LHDs. Interviews were conducted with key personnel involved in LHD vaccination campaigns. Results were analyzed to identify quantitative trends and qualitative themes.

RESULTS:

Twenty-five of 26 LHDs (96% response rate) participated in our survey. Each LHD utilized a different approach to address the challenges they faced during their H1N1 vaccination campaign. Variation between LHDs was found in terms of the types of vaccine-dispensing methods implemented and in the selection of outside organizations LHDs partnered with to assist with vaccinations.

CONCLUSION:

Having a Continuity of Operations Plan (COOP) and pandemic influenza plan, hiring temporary staff, building on existing community partnerships, implementing a variety of vaccination strategies and using a variety of sites are strategies that will help LHDs deal more effectively with challenges posed by future pandemics.

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

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