The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or diphtheria. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices. Under the current schedule, children younger than six may receive as many as 24 immunizations by their second birthday. New vaccines undergo rigorous testing prior to receiving FDA approval; however, like all medicines and medical interventions, vaccines carry some risk. Driven largely by concerns about potential side effects, there has been a shift in some parents' attitudes toward the child immunization schedule. The Childhood Immunization Schedule and Safety identifies research approaches, methodologies, and study designs that could address questions about the safety of the current schedule. This report is the most comprehensive examination of the immunization schedule to date. The IOM authoring committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.

As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.

Vaccination programmes are of vital importance to public health and are present in virtually every country in the world. By promoting an understanding of the diverse effects of vaccination programmes, this textbook discusses how epidemiologic methods can be used to study, in real life, their impacts, benefits and risks. Written by expert practitioners in an accessible and concise style, this book is interspersed with practical examples which allow readers to acquire understanding through real-life data and problems. Part I provides an overview of basic concepts in vaccinology, immunology, vaccination programmes, infectious disease transmission dynamics, the various impacts of vaccination programmes and their societal context. Part II covers the main field tools used for the epidemiological evaluation of vaccination programmes: monitoring coverage and attitudes towards vaccination, surveillance of vaccine-preventable diseases and pathogens, seroepidemiological studies, methods to assess impact and outbreak investigation. Part III is dedicated to vaccine effectiveness and its assessment. Part IV includes an overview of the potential risks of vaccination and how to study these. Lastly, Part V deals with methods for an integrated assessment of benefits and risks of vaccination programmes. Suitable for professionals working in public health, epidemiology, biology and those working in health economics and vaccine development, Vaccination Programmes also serves as a textbook for postgraduate students in public health, epidemiology and infectious diseases. The book is aimed at all those involved in the many aspects of vaccination programmes, including public health professionals and epidemiologists. Its primary target audiences are master and doctoral students in infectious disease epidemiology and public health, post-doctoral participants of field epidemiology training programmes and public health professionals working in the post-implementation epidemiological evaluation of vaccines and vaccination programmes. The Open Access version of this book, available at http://www.taylorfrancis.com, has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives (CC-BY-NC-ND) 4.0 license

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

"Infectious disease outbreaks are frequently characterized by scientific uncertainty, social and institutional disruption, and an overall climate of fear and distrust. Policy makers and public health professionals may be forced to weigh and prioritize potentially competing ethical values in the face of severe time and resource constraints. This document seeks to assist policy-makers, health care providers, researchers, and others prepare for outbreak situations by anticipating and preparing for the critical ethical issues likely to arise."--Publisher.

In this Element and its accompanying second Element, A Practical Introduction to Regression Discontinuity Designs: Extensions, Matias Cattaneo, Nicolás Idrobo, and Rocıìo Titiunik provide an accessible and practical guide for the analysis and interpretation of regression discontinuity (RD) designs that encourages the use of a common set of practices and facilitates the accumulation of RD-based empirical evidence. In this Element, the authors discuss the foundations of the canonical Sharp RD design, which has the following features: (i) the score is continuously distributed and has only one dimension, (ii) there is only one cutoff, and (iii) compliance with the treatment assignment is perfect. In the second Element, the authors discuss practical and conceptual extensions to this basic RD setup.

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.

Animal Biotechnology introduces applications of animal biotechnology and implications for human health and welfare. It begins with an introduction to animal cell cultures and genome sequencing analysis and provides readers with a review of available cell and molecular tools. Topics here include the use of transgenic animal models, tissue engineering, nanobiotechnology, and proteomics. The book then delivers in-depth examples of applications in human health and prospects for the future, including cytogenetics and molecular genetics, xenografts, and treatment of HIV and cancers. All this is complemented by a discussion of the ethical and safety considerations in the field.Animal biotechnology is a broad field encompassing the polarities of fundamental and applied research, including molecular modeling, gene manipulation, development of diagnostics and vaccines, and manipulation of tissue. Given the tools that are currently available and the translational potential for these studies, animal biotechnology has become one of the most essential subjects for those studying life sciences. - Highlights the latest biomedical applications of genetically modified and cloned animals with a focus on cancer and infectious diseases - Provides firsthand accounts of the use of biotechnology tools, including molecular markers, stem cells, and tissue engineering

Testing the immunogenicity, protective efficacy and safety in animal models is a crucial step in vaccine development. Pigs raised in germ-free environments, called gnotobiotic (Gn) pigs, are one of the most useful animal models for testing vaccines. The Gn pig model is a widely accepted model for studying pathogenesis and immunity and an ideal model for pre-clinical testing for the safety and efficacy of enteric viral vaccines. Through these studies and others, the Gn pig model has been established as the most reliable animal model for pre-clinical evaluation of human rotavirus and norovirus vaccines. This book provides detailed information on establishing Gn pig models, determining a proper virus inoculum pool and challenge dose, measuring protection and calculating efficacy, and delineating intestinal and systemic immune responses associated with the protection. Key Features Provides a natural history of human rotavirus and norovirus infection in Gn pigs Establishes the optimal virus challenge doses in Gn pigs for vaccine evaluation Evaluates various candidate rotavirus and norovirus vaccines Discusses human gut microbiota transplanted Gn pig models Documents the role of probiotics and rice bran as prophylactics and vaccine adjuvants