Vaccine Analysis: Strategies, Principles, and Control


Book Description

This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.




Vaccination Strategies Against Highly Variable Pathogens


Book Description

Vaccines against antigenically stable pathogens, or pathogens that only exist in a limited number of serotypes, have been very successful in the past and have drastically decreased the incidence and lethality of many diseases. However, when it comes to highly variable pathogens or viruses that exist in multiple serotypes, the traditional methods for vaccine development have reached their limits. This volume highlights the development of vaccines against such challenging pathogens. Novel approaches for immunogen design, including structure-guided vaccine development and vaccines targeting glycans, as well as adjuvants and animal models used for testing possible vaccine candidates are outlined and discussed in detail. Given its scope, the book will appeal to scientists in the fields of infectious diseases, microbiology and medicine.




The Ethics of Vaccination


Book Description

This open access book discusses individual, collective, and institutional responsibilities with regard to vaccination from the perspective of philosophy and public health ethics. It addresses the issue of what it means for a collective to be morally responsible for the realisation of herd immunity and what the implications of collective responsibility are for individual and institutional responsibilities. The first chapter introduces some key concepts in the vaccination debate, such as ‘herd immunity’, ‘public goods’, and ‘vaccine refusal’; and explains why failure to vaccinate raises certain ethical issues. The second chapter analyses, from a philosophical perspective, the relationship between individual, collective, and institutional responsibilities with regard to the realisation of herd immunity. The third chapter is about the principle of least restrictive alternative in public health ethics and its implications for vaccination policies. Finally, the fourth chapter presents an ethical argument for unqualified compulsory vaccination, i.e. for compulsory vaccination that does not allow for any conscientious objection. The book will appeal to philosophers interested in public health ethics and the general public interested in the philosophical underpinning of different arguments about our moral obligations with regard to vaccination.




Design and Analysis of Vaccine Studies


Book Description

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.




Immunization Safety Review


Book Description

By two years of age, healthy infants in the United States can receive up to 20 vaccinations to protect against 11 diseases. Although most people know that vaccines effectively protect against serious infectious diseases, approximately one-quarter of parents in a recent survey believe that infants get more vaccines than are good for them, and that too many immunizations could overwhelm an infant's immune system. The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that multiple immunizations increase the risk for immune dysfunction. Specifically, the committee looked at evidence of potential biological mechanisms and at epidemiological evidence for or against causality related to risk for infections, the autoimmune disease type 1 diabetes, and allergic disorders.




Veterinary Vaccines


Book Description

Provides a concise and authoritative reference on the use of vaccines against diseases of livestock Compiled by Senior Animal Health Officers at The Food and Agriculture Organization of the United Nations, and with contributions from international leading experts, Veterinary Vaccines: Principles and Applications is a concise and authoritative reference featuring easily readable reviews of the latest research in vaccinology and vaccine immune response to pathogens of major economic impact to livestock. It covers advice and recommendations for vaccine production, quality control, and effective vaccination schemes including vaccine selection, specifications, vaccination programs, vaccine handling in the field, application, failures, and assessment of herd protection. In addition, the book presents discussions on the current status and potential future developments of vaccines and vaccination against selected transboundary animal diseases. Provides a clear and comprehensive guide on using veterinary vaccines to protect livestock from diseases Teaches the principles of vaccinology and vaccine immune response Highlights the vaccine production schemes and standards for quality control testing Offers easy-to-read reviews of the most current research on the subject Gives readers advice and recommendations on which vaccination schemes are most effective Discusses the today’s state of vaccines and vaccination against selected transboundary animal diseases as well as possible future developments in the field Veterinary Vaccines: Principles and Applications is an important resource for veterinary practitioners, animal health department officials, vaccine scientists, and veterinary students. It will also be of interest to professional associations and NGO active in livestock industry.




Bioprocessing of Viral Vaccines


Book Description

This book focuses on cell culture-produced viral vaccines to meet the needs of the rapidly expanding research and development in academia and industry in the field. This book introduces the basic principles of vaccination and the manufacturing of viral vaccines. Bioprocessing of Viral Vaccines, will provide an overview of the advanced strategies needed to respond to the challenges of new and established viral infection diseases. The first few chapters cover the basics of virology and immunology as essential concepts to understand the function and design of viral vaccines. The core of the content is dedicated to process development, including upstream processing and cell culture of viral vaccines, downstream processing, and extensive analytical technologies specific to viral vaccines. Advanced process analytical technologies (PAT) and Quality by Design (QbD) concepts are also introduced in the context of vaccine manufacturing. The case studies included cover inactivated, attenuated vaccines exemplified by influenza vaccines, sub-unit vaccines exemplified by Virus Like Particles (VLPs: HPV vaccines) and sub-unit vaccines (Flublock), vectored vaccines: adenoviruses and Vesicular stomatitis Virus (VSV) vectored vaccines, genomic vaccines (DNA and mRNA) vaccines as developed for COVID-19 response in particular and a review of COVID-19 vaccines approved or in advanced clinical trials. This book is aimed at graduate engineers and professionals in the fields of vaccinology, bioprocessing, and biomanufacturing of viral vaccines.




Priorities for the National Vaccine Plan


Book Description

Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The current political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding, and administering safe and effective vaccines for all people. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. The book makes recommendations about priority actions in the update to the National Vaccine Plan that are intended to achieve the objectives of disease prevention and enhancement of vaccine safety. It is centered on the plan's five goals in the areas of vaccine development, safety, communication, supply and use, and global health.




Novel Strategies in the Design and Production of Vaccines


Book Description

Vaccination is one of the most efficient and cost effective methods of promoting human health and has been in clinical use for at least 200 years. Nevertheless, infectious diseases continue to constitute a constant threat to the well being of humanity. Common pathogens, once believed to be under control, acquire increased virulence and resistance to drugs, while exotic microorganisms emerged from hidden reservoirs to cause yet incurable diseases in humans. These changes, together with epidemic outbreaks related to political and socio-economic instabilities, increase the needs for the development of new, advanced vaccines. In this volume, devoted to the proceedings of the 39th OHOLO Conference, we present some of the recent strategies for the design and production of novel vaccines. The advent of recombinant DNA technology has stimulated the production of several subunit vaccines. In spite of the obvious advantages to this approach, the limited immuno genicity of many subunit candidates has hindered their development. Strategies to enhance the immunogenicity of subunit vaccines is therefore critical. Several approaches toward this goal, including design of novel adjuvants and delivery systems as well as design of advantageous carriers, are presented here. Among the carriers evaluated here are polypep tides (flagellin, HBV core antigen, J3-galactosidase), attenuated virions (Vaccinia, Sindbis), and nonpathogenic licensed bacteria (Salmonella).




Vaccinology


Book Description

Vaccinology: An Essential Guide outlines in a clear,practical format the entire vaccine development process, fromconceptualization and basic immunological principles through toclinical testing and licensing of vaccines. With anoutstanding introduction to the history and practice ofvaccinology, it also guides the reader through the basic sciencerelating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economicand geographical issues that drive vaccine development and trials,it also presents vaccine delivery strategies, novel vaccineplatforms (including experimental vaccines and pathogens), antigendevelopment and selection, vaccine modelling, and the developmentof vaccines against emerging pathogens and agents of bioterror.There are also sections devoted to veterinary vaccines andassociated regulatory processes. Vaccinology: An Essential Guide is a perfect tool fordesigned for undergraduate and graduate microbiologists andimmunologists, as well as residents, fellows and trainees ofinfectious disease and vaccinology. It is also suitable for allthose involved in designing and conducting clinical vaccine trials,and is the ideal companion to the larger reference bookVaccinology: Principles and Practice.