Download or read book Causality assessment of an adverse event following immunization AEFI written by and published by World Health Organization. This book was released on 2019-12-04 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Definition and Application of Terms for Vaccine Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book State of the World s Vaccines and Immunization written by J. M. Maurice and published by World Health Organization. This book was released on 2009-07-20 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Vaccines and Autoimmunity written by Yehuda Shoenfeld and published by John Wiley & Sons. This book was released on 2015-07-07 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Adverse Effects of Vaccines written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-26 with total page 894 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Francisco de Moncada expedicion de los Catalanes y Aragoneses contra Turcos Y Griegos written by and published by . This book was released on with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Mosaic of Autoimmunity written by Carlo Perricone and published by Academic Press. This book was released on 2019-02-15 with total page 728 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Adverse Events Associated with Childhood Vaccines written by Institute of Medicine and published by National Academies Press. This book was released on 1993-01-01 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Childhood immunization is one of the major public health measures of the 20th century and is now receiving special attention from the Clinton administration. At the same time, some parents and health professionals are questioning the safety of vaccines because of the occurrence of rare adverse events after immunization. This volume provides the most thorough literature review available about links between common childhood vaccinesâ€"tetanus, diphtheria, measles, mumps, polio, Haemophilus influenzae b, and hepatitis Bâ€"and specific types of disorders or death. The authors discuss approaches to evidence and causality and examine the consequencesâ€"neurologic and immunologic disorders and deathâ€"linked with immunization. Discussion also includes background information on the development of the vaccines and details about the case reports, clinical trials, and other evidence associating each vaccine with specific disorders. This comprehensive volume will be an important resource to anyone concerned about the immunization controversy: public health officials, pediatricians, attorneys, researchers, and parents.
Download or read book Red Book written by American Academy of Pediatrics. Committee on Infectious Diseases and published by Amer Academy of Pediatrics. This book was released on 2006 with total page 992 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Download or read book IAP Guidebook on Immunization 2018 2019 written by Balasubramanian S and published by Jaypee Brothers Medical Publishers. This book was released on 2019-11-28 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Immunisation against infectious diseases written by David Salisbury and published by The Stationery Office. This book was released on 2006-12-11 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the third edition of this publication which contains the latest information on vaccines and vaccination procedures for all the vaccine preventable infectious diseases that may occur in the UK or in travellers going outside of the UK, particularly those immunisations that comprise the routine immunisation programme for all children from birth to adolescence. It is divided into two sections: the first section covers principles, practices and procedures, including issues of consent, contraindications, storage, distribution and disposal of vaccines, surveillance and monitoring, and the Vaccine Damage Payment Scheme; the second section covers the range of different diseases and vaccines.
Download or read book Immunization Safety Review written by Institute of Medicine and published by National Academies Press. This book was released on 2003-11-26 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the evidence on possible causal associations between immunizations and certain adverse outcomes, and to then present conclusions and recommendations. The committee's mandate also includes assessing the broader societal significance of these immunization safety issues. While all the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. The committee reviews three immunization safety review topics each year, addressing each one at a time. In this fifth report in a series, the committee examines the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40), a virus that causes inapparent infection in some monkeys, can cause certain types of cancer.
Download or read book Thinking in Complexity written by Klaus Mainzer and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the first edition sold out in less than a year, we now present the revised second edition of Mainzer's popular book. The theory of nonlinear complex systems has become a successful problem-solving approach in the natural sciences from laser physics, quantum chaos, and meteorology to computer simulations of cell growth in biology. It is now recognized that many of our social, ecological, and political problems are also of a global, complex, and nonlinear nature. And one of the most exciting contemporary topics is the idea that even the human mind is governed largely by the nonlinear dynamics of complex systems. In this wide-ranging but concise treatment, Prof. Mainzer discusses, in a nontechnical language, the common framework behind these endeavors. Emphasis is given to the evolution of new structures in natural and cultural systems and we see clearly how the new integrative approach can give insights not available from traditional reductionistic methods.
Download or read book Vaccine Safety Communication written by WHO Regional Office for the Western Pacific and published by World Health Organization. This book was released on 2016-04-19 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide enables effective planning and implementation of proactive communication actions to promote understanding of the importance of vaccines in preventing illness and preventable deaths and raises awareness of vaccine risks and perceptions of risk. The guide also covers prompt and effective communication in response to an adverse event following immunization (AEFI) or any other vaccine safety concerns that threaten public trust in a vaccine and compliance with the immunization programme. The guide offers systematic scientific and practical approaches tips and tools to help strengthen the capacity of the various stakeholders in planning implementing managing monitoring and evaluating and documenting communication interventions around vaccine safety issues and immunization.
