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Vaccine Development and Manufacturing

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up.Highlights include:Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agenciesAuthors from different major pharmaceutical and biotechnology companiesDescribes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Vaccine Efficacy Evaluation: The Gnotobiotic Pig Model (Pocket Guides to Biomedical Sciences)

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

The Vaccine-Friendly Plan: Dr. Paul's Safe and Effective Approach to Immunity and Health-from Pregnancy Through Your Child's Teen Years

An accessible and reassuring guide to childhood health and immunity from a pediatrician who's both knowledgeable about the latest scientific research and respectful of a family's risk factors, health history, and concerns In The Vaccine-Friendly Plan, Paul Thomas, M.D., presents his proven approach to building immunity: a new protocol that limits a child's exposure to aluminum, mercury, and other neurotoxins while building overall good health. Based on the results from his pediatric practice of more than eleven thousand children, as well as data from other credible and scientifically minded medical doctors, Dr. Paul's vaccine-friendly protocol gives readers * recommendations for a healthy pregnancy and childbirth * vital information about what to expect at every well child visit from birth through adolescence * a slower, evidence-based vaccine schedule that calls for only one aluminum-containing shot at a time * important questions to ask about your child's first few weeks, first years, and beyond * advice about how to talk to health care providers when you have concerns * the risks associated with opting out of vaccinations * a practical approach to common illnesses throughout the school years * simple tips and tricks for healthy eating and toxin-free living at any age The Vaccine-Friendly Plan presents a new standard for pediatric care, giving parents peace of mind in raising happy, healthy children.

Vaccine Hesitancy in the Nordic Countries: Trust and Distrust During the COVID-19 Pandemic

Bringing together studies from across the Nordic region, this book examines the challenges brought by the COVID-19 pandemic, with a particular focus on vaccine hesitancy. Shedding light on the political tensions that emerged as a result of the pandemic and the debates that ensued both within and between the Nordic nations, it investigates the vociferous discussions surrounding the COVID-19 vaccines and their presumed negative side effects through the lens of trust; trust in and between the neighbouring countries, in healthcare systems, fellow citizens, and experts; in public authorities, politicians, researchers, journalists, and pharmaceutical companies. The first volume to explore vaccine hesitancy in the Scandinavian context, this ground-breaking volume offers fresh perspectives on vaccine scepticism not as a form of ignorance or lack of knowledge, but as a manifestation of a more fundamental lack of faith in modern government and science. As such, it will appeal to scholars of sociology, politics, anthropology, media studies, communication and cultural studies with interests in public health, popular and political discourse and questions of public trust.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.

Vaccine Injuries: Documented Adverse Reactions to Vaccines

Reveals the truth behind the controversial issue of vaccine-related injuries.Proponents declare that vaccines have saved millions of lives. Critics claim that the success is overstated and that vaccines may even be dangerous. <P><P>Many consider mandatory vaccinations a violation of individual rights or religious principles. Many in public health argue that vaccine mandates are critical and justified and that antivaccination sentiment has resulted in outbreaks of preventable childhood illnesses. Vaccine critics point to mainstream medicine's denial of and underreporting of vaccine injury.Vaccine injuries have happened in the past and continue to happen today, and neither the mainstream medical establishment nor the government has ever fully and transparently addressed the issue of vaccine injury. In the 1980s, the United States addressed individual cases of vaccine injury by establishing the NVICP--the National Vaccine Injury Compensation Program--a controversial Department of Health and Human Services program. The NVICP was intended to be "non-adversarial, compassionate, and generous" to vaccine-injury victims. However, many vaccine-injury victims and safety advocates believe that the program is not functioning as intended. There are also concerns that the program is keeping the reality of vaccine injury from public inspection.Vaccine Injuries, a groundbreaking book in the field, reveals cases of vaccine injury from the NVICP--something that has never been offered to the public--and lets readers asses vaccine injuries for themselves.

Vaccine Law and Policy (Law for Professionals)

Vaccine Law and Policy is the first book on vaccine law and policy written specifically for the general public or an educated lay audience without legal background. It offers comprehensive but accessible coverage of key aspects of vaccine law and policy, from product development and intellectual property protections, to regulation, public mandates, and vaccine injury claims. The COVID-19 pandemic sparked a growing interest in learning more about vaccine law and policy, as vaccine development, access, safety and requirements became relevant to hundreds of millions of people worldwide. This book covers United States law in most detail, but the developments and trends described have parallels in many countries, and the United States model and its actions influence others. Some of the most widely used vaccines against COVID-19 - mRNA vaccines – were developed in the United States, and choices made in the United States impact other countries.United States law currently has so much to say about vaccines. From the federal mandate President Biden enacted requiring federal employees to be vaccinated against COVID-19, to the growing number of private employers requiring vaccines to return to work, vaccine law has become a prevalent topic in everyday life. But there is little writing about the legal aspects of vaccines directed at the general public or an educated lay audience without a legal background. Vaccine Law and Policy will not only be invaluable to professionals implementing vaccine law and policy, but also to regulators, public health officials, and scientific researchers.Vaccine Law and Policy covers the wide range of laws and policies that impact the field. These include, among others, regulatory oversight by the FDA, one of the most influential bodies in drug and vaccines regulation worldwide, enforcement, and regulation of the research and development of vaccines; vaccine mandates for children and in the workplace, and medical, religious, and philosophical exemptions to them; patent law and other intellectual property protections such as trademark, trade secret, unfair competition, and copyright law; compensation for vaccine injuries under the National Vaccine Injury Compensation Program (NVICP) and other avenues of liability; safety monitoring; access to vaccines, their promotion, and issues related to funding and costs. The book will also discuss issues related to anti-vaccine movements and vaccine advocacy.

Vaccine Nation: America's Changing Relationship with Immunization

With employers offering free flu shots and pharmacies expanding into one-stop shops to prevent everything from shingles to tetanus, vaccines are ubiquitous in contemporary life. The past fifty years have witnessed an enormous upsurge in vaccines and immunization in the United States: American children now receive more vaccines than any previous generation, and laws requiring their immunization against a litany of diseases are standard. Yet, while vaccination rates have soared and cases of preventable infections have plummeted, an increasingly vocal cross section of Americans have questioned the safety and necessity of vaccines. In Vaccine Nation, Elena Conis explores this complicated history and its consequences for personal and public health. Vaccine Nation opens in the 1960s, when government scientists--triumphant following successes combating polio and smallpox--considered how the country might deploy new vaccines against what they called the "milder” diseases, including measles, mumps, and rubella. In the years that followed, Conis reveals, vaccines fundamentally changed how medical professionals, policy administrators, and ordinary Americans came to perceive the diseases they were designed to prevent. She brings this history up to the present with an insightful look at the past decade’s controversy over the implementation of the Gardasil vaccine for HPV, which sparked extensive debate because of its focus on adolescent girls and young women. Through this and other examples, Conis demonstrates how the acceptance of vaccines and vaccination policies has been as contingent on political and social concerns as on scientific findings. By setting the complex story of American vaccination within the country’s broader history, Vaccine Nation goes beyond the simple story of the triumph of science over disease and provides a new and perceptive account of the role of politics and social forces in medicine.

Vaccine Nation: America's Changing Relationship with Immunization

&“A strikingly honest, fair-minded, and informed chronicle of the vaccine controversy in the United States.&”—Age of Autism By setting the complex story of American vaccination within the country&’s broader history, Vaccine Nation goes beyond the simple story of the triumph of science over disease and provides a new and perceptive account of the role of politics and social forces in medicine.Vaccine Nation opens in the 1960s, when government scientists—triumphant following successes combating polio and smallpox—considered how the country might deploy new vaccines against what they called the &“milder&” diseases, including measles, mumps, and rubella. In the years that followed, Conis reveals, vaccines fundamentally changed how medical professionals, policy administrators, and ordinary Americans came to perceive the diseases they were designed to prevent. She brings this history up to the present with an insightful look at the past decade&’s controversy over the implementation of the Gardasil vaccine for HPV, which sparked extensive debate because of its focus on adolescent girls and young women. Through this and other examples, Conis demonstrates how the acceptance of vaccines and vaccination policies has been as contingent on political and social concerns as on scientific findings. In Vaccine Nation, Conis delivers &“a fascinating account of how routine childhood immunization came to be both a public health success story and a source of bitter controversy&” (James Colgrove, author of Epidemic City and State of Immunity). &“At a moment when, as Conis says, children&’s participation in public life depends on their immunization status, she favors a nuanced view of our complicated relationship with &‘the jab.&’&”—Los Angeles Times

Vaccine Protocols

This extensively revised, updated, and expanded second edition of a classic laboratory manual applies new understanding of molecular mechanisms to the rational design and development of vaccines. Here the working researcher will find readily reproducible techniques for the development and production of live attenuated vaccines, and vaccines based on inactivated toxins, peptides, and polysaccharide conjugates. New to this edition are cutting-edge chapters on two different viral vectors (Vaccinia and Semliki Forest), lactic acid bacteria for delivery of foreign antigens, incorporation of immunomodulators into plasmid DNA vaccines, construction of tetramer complexes to detect CMI responses, assessment of functional antibody responses, and the use of complete genome sequences for vaccine design. There are also chapters describing more general techniques for vaccine formulation, delivery, and assessment of immune responses, and review discussions of scale-up to manufacture, vaccine quality assurance, and clinical trials.

The Vaccine Race: Science, Politics, and the Human Costs of Defeating Disease

“This is a story about the war against disease—a war without end—and the development of enormously important vaccines, but in telling that story, in showing how science works, Meredith Wadman reveals much more. I loved this book.” —John M. Barry, New York Times bestselling author of The Great InfluenzaThe epic and controversial story of a major breakthrough in cell biology that led to the conquest of rubella and other devastating diseases. Until the late 1960s, tens of thousands of American children suffered crippling birth defects if their mothers had been exposed to rubella, popularly known as German measles, while pregnant; there was no vaccine and little understanding of how the disease devastated fetuses. In June 1962, a young biologist in Philadelphia, using tissue extracted from an aborted fetus from Sweden, produced safe, clean cells that allowed the creation of vaccines against rubella and other common childhood diseases. Two years later, in the midst of a devastating German measles epidemic, his colleague developed the vaccine that would one day wipe out homegrown rubella. The rubella vaccine and others made with those fetal cells have protected more than 150 million people in the United States, the vast majority of them preschoolers. The new cells and the method of making them also led to vaccines that have protected billions of people around the world from polio, rabies, chicken pox, measles, hepatitis A, shingles and adenovirus. Meredith Wadman’s masterful account recovers not only the science of this urgent race, but also the political roadblocks that nearly stopped the scientists. She describes the terrible dilemmas of pregnant women exposed to German measles and recounts testing on infants, prisoners, orphans, and the intellectually disabled, which was common in the era. These events take place at the dawn of the battle over using human fetal tissue in research, during the arrival of big commerce in campus labs, and as huge changes take place in the laws and practices governing who “owns” research cells and the profits made from biological inventions. It is also the story of yet one more unrecognized woman whose cells have been used to save countless lives. With another frightening virus imperiling pregnant women on the rise today, no medical story could have more human drama, impact, or urgency today than The Vaccine Race.From the Hardcover edition.

Vaccine Research and Development: Volume 1: (Vaccine Research and Developments)

Serving as a complementary series to AIDS Research Reviews - edited by Drs. Wayne C. Koff, Flossie Wong-Staal, and Ronald C. Kennedy (Marcel Dekker, Inc.) - this new series reviews significant advances in immunization research and addresses scientific and public policy challenges for moving candidate vaccines from the laboratory to the population.;Exploring recent progress in immunology, vaccine development and improvement, and clinical trials, Vaccine Research and Developments: analyzes the capacity of lipophilic components to chemically modify peptide and protein antigens and augment their immunogenicity; discusses the potential of noninfectious packaging mutants to serve as prototype vaccines; provides a novel presentation system for peptide vaccines through the multiple antigen peptide approach; examines the current status and future prospects for contraceptive vaccines and offers perspectives for improving pertussis vaccines; furnishes a comprehensive update of vaccine clinical trials; and describes the legal policy aspects involved in developing HIV vaccines.;Containing over 915 useful references, Vaccine Research and Developments is for immunologists, microbiologists and virologists, molecular and cell biologists, infectious disease specialists, pharmacologists, government and industry drug regulatory personnel, and graduate level students in these disciplines.

Vaccine Safety Forum: Summaries of Two Workshops

Information on a Vaccine Safety Forum

Vaccine Safety Research, Data Access, AND Public Trust

The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database. In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

Vaccine Science and Immunization Guideline

This book is a comprehensive resource on vaccines and immunizations for primary care physicians, advanced practice providers, and trainees. We are now seeing a rise in measles and the potential for rises in other previously rare infectious diseases, significantly due to public and physician misconceptions and misinformation about vaccines. The text addresses this issue by consolidating historical and current advances in vaccine science from how vaccines are developed to CDC recommendations on how and when to administer them. Expert authors also address barriers to improving vaccination rates in the U. S. and offer evidence-based recommendations on overcoming those barriers. This is an essential guide for primary care physicians, family physicians, pediatricians, internists, residents, medical students, mid-level providers, and learners for understanding vaccines and improving preventative care for their patients.

Vaccine Technologies for Veterinary Viral Diseases

This detailed volume explores the most popular antigen production and delivery strategies that have been tested in veterinary species. Viral vectors as well as genetic and protein subunit vaccines or large scale protein production systems are considered as well as an updated view of most options available for vaccine development, including the data obtained through experimental trials which contributes to the exploration and understanding of the immune mechanisms and immune correlates relevant in protection among different animal species. Written for the highly successful Methods in Molecular Biology series, chapters include brief introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Vaccine Technologies for Veterinary Viral Diseases: Methods and Protocols facilitates access to well-established protocols to those beginning in this interesting and laborious field as well as providing important basic knowledge when attempting a novel vaccine design or platform.

Vaccine Technologies for Veterinary Viral Diseases: Methods and Protocols (Methods in Molecular Biology #2465)

This second edition includes a collection of antigen production and delivery strategies for vaccine development in veterinary species. New and updated chapters guide readers through protocols for antigen production, experimental antigen delivery and the analysis of immune responses upon vaccination. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols. Authoritative and cutting-edge, Vaccine Technologies for Veterinary Viral Diseases: Methods and Protocols, Second Edition aims to be a useful and practical guide to researches to help further their study in this field.

Vaccine Wars: The Two-hundred-year Fight For School Vaccinations

Vaccine Whistleblower: Exposing Autism Research Fraud at the CDC

A Firsthand Account from a CDC Insider on the Link between Vaccines and Autism Vaccine Whistleblower is a gripping account of four legally recorded phone conversations between Dr. Brian Hooker, a scientist investigating autism and vaccine research, and Dr. William Thompson, a senior scientist in the vaccine safety division at the Centers for Disease Control and Prevention (CDC). Thompson, who is still employed at the CDC under protection of the federal Whistleblower Protection Act, discloses a pattern of data manipulation, fraud, and corruption at the highest levels of the CDC, the federal agency in charge of protecting the health of Americans. Thompson states, "Senior people just do completely unethical, vile things and no one holds them accountable. ” This book nullifies the government’s claims that "vaccines are safe and effective,” and reveals that the government rigged research to cover up the link between vaccines and autism. Scientific truth and the health of American children have been compromised to protect the vaccine program and the pharmaceutical industry. The financial cost of the CDC’s corruption is staggering. The human cost is incalculable. Vaccine Whistleblower provides context to the implications of Thompson’s revelations and directs the reader to political action.

Vaccines: A Biography

The History and Biography of Vaccines against Infectious Diseases is a multi-authored book, written for an academic audience but accessible to a general readership as well. The book examines the human stories that underlie the development of vaccines against infectious diseases. Each chapter traces the lineage of a vaccine by examining the people behind the scientific hypotheses and discoveries that led to vaccine breakthroughs. These stories are firmly anchored in their historical context, as the "biography" of a vaccine generally has its origins in a medical problem rooted within a social context that subsequently engages scientists and enlists others in the eventual solution. A prominent theme woven throughout the book is the interdependence of incremental scientific advances and investigators on one another and how such advances ultimately led to practical, preventive solutions to major public health problems in society. Additionally, the human aspect of various pivotal events in the histories of specific vaccines are illustrated--this includes scientific and political hurdles and details of clinical trial controversies. In this fashion the work interweaves scientific themes, personal stories of those involved, and the sociohistorical context in which they worked in a manner that illustrates their inter-relatedness and provides the reader with exciting accounts of these advances.

Vaccines: A Clinical Overview and Practical Guide

This book is designed to provide easy-to-read and basic information about vaccines for those undertaking a vaccine course or for medical providers seeking to improve their skills. Written by expert medical educators in the areas of infectious diseases, medical microbiology, and pediatrics, this book begins by establishing the fundamentals of vaccines such as what constitutes a vaccine, how they are manufactured and composed, how they are tested for safety and efficacy, and how vaccine recommendations are developed and conveyed to health care providers and their patients. The book then explains the composition, safety profile, effectiveness, and current recommendations for use of every available vaccine, alphabetized by infection. The concluding section illuminates practical concerns every vaccinating clinician experiences, including vaccine confidence and hesitancy, misconceptions, and patient communication. Vaccines: A Clinical Overview and Practical Guide is an excellent learning tool for all students and providers administering vaccines to patients, including infectious disease specialists and other internal medicine subspecialists, pediatricians, geriatricians, as well as all other primary care physicians, nurse practitioners, physician’s assistants, and nurses.

Vaccines: Are they Worth a Shot?

The dangerous decline in vaccinations in many developed countries is at the heart of a lively debate that confirms how important the subject is today. Vaccinations are among mankind’s most important scientific discoveries, yet they continue to be viewed with suspicion by part of the public – the victims of disinformation campaigns, instrumentalization and unfounded fears. There is, however, also an evolutionary explanation for these irrational beliefs, and countering the growing social opposition will be extremely difficult without grasping it. This book, which sheds new light on the safety and importance of vaccinations, is intended both for parents and those readers who want to understand the role of vaccinations in contemporary society, where the ease of access to knowledge is both a great opportunity and a great responsibility. The chapters follow a historical progression and conclude with a discussion of the most recent cognitive theories on how to overcome this opposition to vaccinations.

Vaccines: A Safer World, One Shot at a Time (Fountas & Pinnell LLI Purple #Level W)

Vaccines: A Safer World, One Shot at a Time by Miles Zapata *** SOLVING PROBLEMS SERIES

Vaccines 2.0: The Careful Parent's Guide to Making Safe Vaccination Choices for Your Family

The CDC's bloated vaccine schedule has doubled since 1988, after the federal government gave pharmaceutical companies immunity from lawsuits. Autism and other childhood disorders like asthma, ADHD, juvenile diabetes and digestive ailments have skyrocketed. And parents are understandably nervous, desperate for objective guidance that takes those concerns seriously.Vaccines 2.0 looks at the lengthy roster of today's recommended injections, the documented risks that accompany them, and helps parents choose a schedule based on unbiased, uncensored, unconflicted science. From whether to get a flu shot during pregnancy--and how to avoid dangerous mercury if you do--to the Hep B shot within hours of birth, to the controversial Gardasil vaccine for preteens, Vaccines 2.0/i> provides the tools to decide for yourself.The three sections cover: Why should you care? What should you know? What can you do? The exclusive Risk-Reward Assessment assigns a numerical score to each of the 14 recommended vaccines. Also included is information on learning to spot, report and treat side effects; talking to your doctor and finding a sympathetic one if you can't, and comparing alternative schedules if you decide to delay or skip shots. When it comes to your child, it's your choice. Vaccines 2.0 will give you the information you need to choose wisely.

Vaccines against Allergies

We are celebrating this year the hundred years´ anniversary of allergen-specific immunotherapy. In 1911 Leonard Noon published his seminal work "Prophylactic inoculation against hay fever" describing his attempts to achieve active immunity against "grass pollen toxin" by administering increasing doses of grass pollen extract before the grass pollen season to allergic patients. Although it was unknown at that time that allergy represents an immunological hypersensitivity disease, the treatment was effective and many observations made by Noon remained valid until today. Today allergen-specific immunotherapy is well established as the only allergen-specific and disease-modifying treatment for IgE-mediated allergies and has long-lasting effects. In fact, more than 25% of the population suffer from IgE-mediated allergies which therefore represent a major health burden of our society, particularly because untreated allergy often progresses to severe disabling forms of disease, such as asthma and sometimes kills sensitized people through anaphylaxis.

Vaccines and Your Child: Separating Fact from Fiction

Paul A. Offit and Charlotte A. Moser answer questions about the science and safety of modern vaccines. In straightforward prose, they explain how vaccines work, how they are made, and how they are tested. Most important, they separate the real risks of vaccines from feared but unfounded risks. Offit and Moser address parental fears that children may receive too many vaccines too early, that the HPV vaccine may cause chronic fatigue or other dangerous side effects, that additives and preservatives in vaccines cause autism, and that vaccines might do more harm than good. There couldn't be a better moment or more pressing need for this book, which offers honesty-instead of hype-in the quest to protect children's health.