Causality assessment of an adverse event following immunization (AEFI)

Causality assessment of an adverse event following immunization (AEFI) PDF

Author:

Publisher: World Health Organization

Published: 2019-12-04

Total Pages: 88

ISBN-13: 9241516992

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Since the 2013 publication of the “Causality assessment of an adverse event following immunization (AEFI), user manual for the revised WHO classification”, there has been extensive global interest in adopting the new revised causality assessment methodology for vaccine pharmacovigilance systems. WHO provided technical support and helped build capacity in countries of all WHO Regions who wanted to use the revised methodology. Recently, the new methodology has been scientifically evaluated. In April 2017, WHO coordinated an India - Zimbabwe project entitled “Inter-country study to assess the inter-rater reliability of the WHO AEFI causality assessment methodology and the utility of the new WHO AEFI causality assessment software”. The quantitative aspect of the study determined that there was realistic agreement between assessors in their findings. The qualitative aspect of the study identified areas of the methodology that could be made even more robust by the use of more accurate and clearer language, semantics and graphics. In the meanwhile, feedback from surveillance systems and other research studies have shed new evidence on areas such as, “substandard and falsified vaccines”, “immunization anxiety” and “immunization stress-related responses” that need to be incorporated into new guidance documents.

Definition and Application of Terms for Vaccine Pharmacovigilance

Definition and Application of Terms for Vaccine Pharmacovigilance PDF

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher:

Published: 2012

Total Pages: 0

ISBN-13: 9789290360834

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This report from the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010). This working group brought together experts from both industrialized and emerging countries representing regulatory agencies, vaccine industry, national and international public health bodies including WHO and CIOMS, academia and clinical care, contributing from their different perspectives. The report covers general terms and definitions for vaccine safety and discusses the application of such harmonized tools in vaccine safety surveillance and studies. As well, the report highlights case definitions for adverse events typically reported for vaccines. The report is addressed to those engaged in vaccine safety data collection and evaluation, and will also make a useful reading for others who want to familiarize themselves with vaccine safety terminology.

State of the World's Vaccines and Immunization

State of the World's Vaccines and Immunization PDF

Author: J. M. Maurice

Publisher: World Health Organization

Published: 2009-07-20

Total Pages: 204

ISBN-13: 9241563869

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This casebook collects 64 case studies each of which raises an important and difficult ethical issue connected with planning, reviewing or conducting health-related research. The book's purpose is to contribute to thoughtful analysis of these issues by researchers and members of research ethics committees (REC's known in some places as ethical review committees or institutional review boards) particularly those involved with studies that are conducted or sponsored internationally. . This collection is envisioned principally as a tool to aid educational programs from short workshops on research.

Vaccines and Autoimmunity

Vaccines and Autoimmunity PDF

Author: Yehuda Shoenfeld

Publisher: John Wiley & Sons

Published: 2015-07-07

Total Pages: 394

ISBN-13: 1118663438

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In light of the discovery of Autoimmune Syndrome Induced by Adjuvants, or ASIA, Vaccines and Autoimmunity explores the role of adjuvants – specifically aluminum in different vaccines – and how they can induce diverse autoimmune clinical manifestations in genetically prone individuals. Vaccines and Autoimmunity is divided into three sections; the first contextualizes the role of adjuvants in the framework of autoimmunity, covering the mechanism of action of adjuvants, experimental models of adjuvant induced autoimmune diseases, infections as adjuvants, the Gulf War Syndrome, sick-building syndrome (SBS), safe vaccines, toll-like receptors, TLRS in vaccines, pesticides as adjuvants, oil as adjuvant, mercury, aluminum and autoimmunity. The following section reviews literature on vaccines that have induced autoimmune conditions such as MMR and HBV, among others. The final section covers diseases in which vaccines were known to be the solicitor – for instance, systemic lupus erythematosus – and whether it can be induced by vaccines for MMR, HBV, HCV, and others. Edited by leaders in the field, Vaccines and Autoimmunity is an invaluable resource for advanced students and researchers working in pathogenic and epidemiological studies.

Adverse Effects of Vaccines

Adverse Effects of Vaccines PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-04-26

Total Pages: 894

ISBN-13: 0309214351

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In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children. Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

Practical Aspects of Signal Detection in Pharmacovigilance

Practical Aspects of Signal Detection in Pharmacovigilance PDF

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher: Cioms

Published: 2010

Total Pages: 0

ISBN-13: 9789290360827

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In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.

Pharmacoepidemiology

Pharmacoepidemiology PDF

Author: Brian L. Strom

Publisher: John Wiley & Sons

Published: 2019-12-16

Total Pages: 1220

ISBN-13: 1119413419

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This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

Mosaic of Autoimmunity

Mosaic of Autoimmunity PDF

Author: Carlo Perricone

Publisher: Academic Press

Published: 2019-02-15

Total Pages: 728

ISBN-13: 012814307X

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The Mosaic of Autoimmunity: The Novel Factors of Autoimmune Diseases describes the multifactorial origin and diversity of expression of autoimmune diseases in humans. The term implies that different combinations of factors in autoimmunity produce varying and unique clinical pictures in a wide spectrum of autoimmune diseases. Most of the factors involved in autoimmunity can be categorized into four groups: genetic, immune defects, hormonal and environmental factors. In this book, the environmental factors are reviewed, including infectious agents, vaccines as triggers of autoimmunity, smoking and its relationship with rheumatoid arthritis, systemic lupus erythematosus, thyroid disease, multiple sclerosis and inflammatory bowel diseases. An entirely new syndrome, the autoimmune/inflammatory syndrome induced by adjuvants (ASIA), is also included, along with other diseases that are now recognized as having an autoimmune etiopathogenesis. Highlights the concept of the mosaic of autoimmune manifestations Includes new visions on unsuspected molecules Provides updated knowledge to physicians helping patients with autoimmune diseases Presents thorough, up-to-date information on specific diseases, along with clinical applications

Red Book

Red Book PDF

Author: American Academy of Pediatrics. Committee on Infectious Diseases

Publisher: Amer Academy of Pediatrics

Published: 2006

Total Pages: 992

ISBN-13: 9781581101942

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"Reliable and clinically useful information on the manifestations, etiology, epidemiology, diagnosis, and treatment of some 200 childhood infectious diseases. The new 27th edition has been thoroughly revised and updated to help you stay in step with the latest developments and recommendations. And it has been expanded with a wealth of must-know new clinical content in key areas like active and passive immunization; care of children in special circumstances; management of specific conditions such as anthrax, smallpox, influenza, and pneumococcal infections; and much more."--Publisher description.