在漫长的历史长河中，人类面对传染病，往往都只能节节败退，直到疫苗的诞生。疫苗是人类控制传染病的主要手段，被视为20世纪最伟大的公共卫生成就之一。疫苗的发明起源于18世纪一次偶然的牛痘接种。1796年英国医生Edward Jenner给一个小男孩注射了牛痘疱液，使其成功获得了天花免疫力，这就是人类的第一支疫苗。随后，疫苗学逐步发展起来。
疫苗的工作原理是通过模拟人体自然感染病原体过程使人体主动产生抗体，进而在病原体再次感染时能够快速产生免疫应答。随着生物技术的快速发展，疫苗技术不断升级迭代，从传统的减毒活疫苗、灭活疫苗、亚单位疫苗等，逐渐发展为基因工程疫苗、重组载体疫苗、核酸疫苗等新型疫苗，同时在免疫原性和安全性方面取得了显著的提升和突破。
2024 年，我国疫苗行业呈现出调整期特征。从批签发情况看，2024 年疫苗整体批签发次数为3,966 批次，较 2023 年的 4,613 批次同比下降 14%。这一降幅明显大于 2023 年的 6.9%，表明行业调整进一步深化。
从批签发总量来看，截至 2024 年 12 月 31 日，我国累计 47 家企业通过疫苗批签发，批签发总量为5.43 亿剂，其中，免疫规划疫苗 2.22 亿剂，非免疫规划疫苗 3.21 亿剂。与 2023 年的 5.75 亿剂相比，同比减少 5.6%。
在疫苗产品管线布局方面，重磅产品管线领域有带状疱疹疫苗、肺炎疫苗、HPV疫苗、流感疫苗、狂犬病疫苗等；值得关注的新疾病领域疫苗有RSV疫苗、肿瘤mRNA疫苗等。国内部分疫苗的在研产品管线如下。
值中国国庆之际，小编精选了关于疫苗在研发、生产、临床及应用等方面的21本书籍和大家一起学习交流，有兴趣的老师可以扫码登记，符合要求方可加入我们学习行列。快快加入我们喔，一起过一个充实而又愉快的国庆节！
01 Vaccines for Neglected Pathogens: Strategies, Achievements and Challenges: Focus on Leprosy, Leishmaniasis, Melioidosis and Tuberculosis
This book reviews successes and (remaining) challenges in vaccine development for the selected Neglected Tropical Diseases (NTD) of Leprosy, Leishmaniasis, Meliodoisis and Tuberculosis, which are a continuous burden for millions of people in affected areas worldwide. Written by frontline researchers, the volume deep-dives into different vaccine strategies, provides biotechnological background information and also tackles animal models in NTD therapeutics research. By bringing together state-of-the-art expert knowledge, the book contributes to the aim of ultimately ending the epidemics of neglected tropical diseases, complying with UN Sustainable Development Goal 3, Health and Well-Being. The volume highlights the activities of the research network VALIDATE (VAccine deveLopment for complex Intracellular neglecteD pAThogEns), funded by the Medical Research Council in the UK. The four NTDs discussed in the book were selected as these are in the focus of VALIDATE’s research. The book targets scientists and clinicians working on NTDs, as well as all readers with a background in biomedicine and interest in vaccine development. This is an open access book.
02 Spray Drying of Vaccines: From Laboratory Research to Industrial Applications
This book addresses the stabilization of vaccine powders by spray drying and provides an overview of the current state of the art on a laboratory and industrial scale. The book aims to familiarize readers with the advances in vaccine spray drying technology to understand its application potential better. In particular, the book addresses the design of aseptic spray dryers, parameters affecting the spray drying process, sterile powder processing, cleaning procedures, and powder filling. In addition, different drying technologies for the production of dry powder vaccines are compared to discuss the unique capabilities of spray drying as a particle technology for vaccines. Special attention is given to research studies on spray-dried vaccines published over the past 30 years, with key findings from laboratory research to clinical trials. Potential applications of spray-dried vaccines and routes of administration are presented in detail. Finally, an outlook is given on how close the aseptic spray-drying of vaccines is to the market and the challenges that need to be overcome to be commercially successful. The book's target audience is academics, researchers, vaccine developers, industry experts, students, and possibly funders, including government agencies, who are active in the field. In addition, the book is a reference source for those involved in the vaccine formulation and biopharmaceutical processing industry.
03 Computational Vaccine Design
This volume explores computational vaccine design and the technologies that support it. Chapters have been divided into four parts detailing immunonics and system immunology, databases, prediction of antigenicity and immunogenicity, and computational vaccinology. 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, Computational Vaccine Design: Methods and Protocols aims to reflect on the rigorous and imaginative use of computational technologies to help catalyze future efforts and to improve global public health through the development of a broad range of novel vaccines.
04 A History of Vaccines and Their Opponents
A History of Vaccines and Their Opponents describes the history of this opposition as well as its changing rationale over the years and in different societies. The Coronavirus pandemic that began in 2019 brought to the forefront the presence of a significant minority of individuals who strongly oppose vaccinations. However, this opposition is by no means recent. Ever since the very first attempts to immunize individuals, opposition has been intense in some societies. The reasons for this opposition range from religious, to political and medical. This discussion may ultimately provide some suggestions for reducing hesitancy in the future. Although vaccines have eliminated smallpox and largely eliminated polio and measles, opposition to vaccination persists and, in some countries, has grown stronger.
05 The Marathon of the Messenger: A History of Messenger RNA Vaccines
The Covid-19 pandemic changed the world. Indeed a real race took place worldwide between SARS-CoV-2 on the one hand and researchers on the other – especially those specializing in messenger RNA vaccines. Four years after its emergence, the pandemic is not over, but some decisive battles have been won, thanks to the great success of mRNA vaccines. The Marathon of The Messenger presents the history of these mRNA vaccines, combining a scientific background with historical and economic perspectives. It appears that an important page in the history of these new vaccines was written in Europe, thanks to the crucial work of German and French scientists; this effort began in 1993 and continues to this day. In the face of a prevailing single-mindedness, these researchers pushed through a new therapeutic concept and defined the biotechnological keys that would open the way to the production of therapeutic messenger RNA in the fight against cancer and viral infections. Written for a broad audience and accompanied by humorous cartoons, this book will appeal to anyone looking for scientific and historical answers about mRNA vaccines. Readers will discover not only the technical and scientific knowledge of how these vaccines work, but also the economic levers that were necessary to create this technology. This book has been written in collaboration with Dr. Steve Pascolo, former director of CureVac, and the RNA messenger expert Professor Chantal Pichon. It also features a preface by Dr. Pierre Meulien, former director of the European Union public-private partnership Innovative Medicines Initiative (IMI).
06 Access To Medicines And Vaccines: Implementing Flexibilities Under Intellectual Property Law
This book is the outcome of a Global Forum on Innovation, Intellectual Property and Access to Medicines held in December 2019 at the Max Plank Instititute in Munich, organised by the South Centre and the Max Plank Institute. The academics and experts from international organisations participating have contributed chapters to this book. The book is for policy makers (in Ministries of Health, Ministries of Trade, Ministries of Foreign Affairs, patent offices), but also relevant for academics (law, trade, public health), on the flexibilities available in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization to promote access to medicines.
This volume provides a practical guide providing step-by-step methods and protocols on vaccine development and production. Divided into three volumes,Volume 3: Resources for Vaccine Development guides readers through chapters on vaccine adjuvants, vaccine vectors, production, vaccine delivery systems, vaccine bioinformatics, vaccine regulation, and intellectual property. 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 practical,Vaccine Design: Methods and Protocols, Second Edition, Volume 3: Resources for Vaccine Development aims to be a useful practical guide to researchers to help further their study in this field.
08 Vaccine Design: Methods and Protocols, Volume 1. Vaccines for Human Diseases
This volume provides a practical guide providing step-by-step protocol to design and develop vaccines for human diseases. Divided into three volumes,Volume 1: Vaccines for Human Diseases guides readers through an introductory section on future challenges for vaccinologists and the immunological mechanism of vaccines. Chapters focus on design of human vaccines for viral, bacterial, fungal, and parasitic diseases as well as tumor vaccines. 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 practical, Vaccine Design: Methods and Protocols, Second Edition, Volume 1: Vaccines for Human Diseases aims to be a useful practical guide to researchers to help further their study in this field.
09 Vaccine Technologies for Veterinary Viral Diseases: Methods and Protocols
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 successfulMethods 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.
10 mRNA Vaccines
The formulation and the technological advancements in RNA biology, chemistry, stability, and encapsulated delivery systems that have enabled the development of fully synthetic mRNA vaccines are discussed in this volume. The applications of the mRNA technology is covered, focusing on infectious diseases but also touching on other indications, such as immunotherapies and molecular therapies. Potent and long-lasting immune responses observed in animal models, encouraging data from early human clinical studies, together with the success of two mRNA-basedCOVID-19 vaccines support the use of mRNA-based vaccination as an attractive alternative to conventional vaccine approaches. Consequently, the development progress of the technology, particularly on production, capabilities, and clinical development is reviewed. Topics on safety, regulatory issues, and possible challenges to the mRNA vaccination approach round off this book. Thanks to their high potency, the prospect for generic, low-cost manufacturing processes, and entirely synthetic nature, the future for mRNA vaccines is highly promising. Importantly, mRNA vaccines have the potential to minimize the time between pathogen identification and vaccine release with a huge impact on public health.
As the mRNA-based vaccination technology has been progressing rapidly, the book is intended to be an end-to-end review series, covering everything from basic RNA biology and preclinical studies to the manufacturing strategy, clinical development and regulatory approval. It provides established RNA researchers and developers with updates on the latest advancements in the field and allows for a quick but comprehensive overview of this transformative technology, its application, and future potential.
11 Messenger RNA Therapeutics
Professor Stefan Jurga conducts interdisciplinary scientific research in the field of nanoscience and nanotechnology, covering the physical, chemical, biological and medical sciences. He has authored over 270 publications in the interdisciplinary database Journal Citation Reports. He has served as Visiting Professor at, e.g., Cornell University, North Carolina State University, and the University of South Africa in Pretoria. He was a laureate of the Alexander von Humboldt Foundation and a scholarship holder at the Max Planck Institute for Polymer Research in Mainz (Germany). He has also worked at the University of Illinois at Urbana Champaign, at the Józef Stefan Institute in Ljubljana, and at many other international scientific institutions. He has served as Vice-Rector and Rector of the Adam Mickiewicz University Poznań (AMU) and also created the interdisciplinary NanoBioMedical Center at the AMU, which he has been the director of since 2010. From 2005 to 2007, he was appointed as the Under Secretary and Secretary of State for research and higher education at the Ministry of Education and Science and the Ministry of Science and Higher Education.
Jan Barciszewski is Professor at Adam Mickiewicz University (AMU) in Poznań, Poland and at the Institute of Bioorganic Chemistry of the Polish Academy of Sciences, Poznań, Poland where he has worked since 1974. He studied organic chemistry at the AMU. During his Ph.D. studies, he worked on the structure and function of modified bases and nucleoside sequences of plant phenylalanine specific transfer ribonucleic acid (tRNA), including cytokinins. He was subsequently granted Doctor of Science degree for his work on the properties of plant tRNAs and aminoacyl-tRNA synthetases. In the 1990s, he began working on the diagnosis and therapy of brain tumors. He developed a new method for the transformation of plant mitochondria based on catalytic RNAs and is currently involved in studies on a new type of catalytic RNAs (enantiomeric ribozymes) for efficient RNA target cleavage in vivo, as well as the search for new anti-aging agents.
12 Challenges and Opportunities of mRNA Vaccines Against SARS-CoV-2: A Multidisciplinary Perspective
This book offers an analytical look at the much debated risks and benefits of the newly developed COVID-19 mRNA-vaccines. As such, it is one of the firstbooks to give a comprehensive overview of mRNA vaccines against COVID-19 and the only one that addresses this topic from a broad multidisciplinary background. It brings together insights from various underlying disciplines on the challenges of developing and evaluating the most suitable vaccines for mass vaccination programs enrolled throughout the world - focusing on safety and efficacy.This book should not be missing on the shelf of any biomedical researcher, epidemiologist, public health professional or clinical researcher interested in SARS-CoV2 or virology and vaccine development in general.
13 mRNA Vaccine Toxicity
Readers of our website [D4CE.org] will be aware that the mRNA vaccines that have been used against COVID-19 have caused injury and death on an unprecedented scale in the history of medicine.This book argues that these harms had to be expected from first principles of immunology. Furthermore, they are not limited to the COVID vaccines alone; instead, they are inherent in the mRNA technology as such. We must therefore expect that future mRNA vaccines against other viruses or bacteria will be similarly toxic. mRNA technology will never be safe to use for vaccination against any infectious agent.
14 Textbook of Microbiology and Immunology
The fourth edition of “Textbook of Microbiology and Immunology” is an extensively revised edition , a healthy mixture of the old and the new contents. Many of the old traditional chapters have been retained with addition of new information along with the inclusion of new chapters more in line with the on-going changes in the syllabus and concepts in Medical Microbiology .While doing so, this book has blended the traditional organism-based learning and a syndrome based approach to infectious disease, together with the introduction of new and modified chapters incorporating the latest information in this field.The book provides an extensive coverage of fundamental topics in general and medical microbiology. The book also lays due emphasis on clinical microbiology with special focus on syndrome based approach to infectious diseases. It includes the basic concepts of microbiology as well as the recent updates and developments in the field of medical microbiology. All the topics have been incorporated in seven major sections: General microbiology, Immunology, Bacteriology, Virology, Mycology, and Applied and Clinical Microbiology.The dynamic nature of medical sciences with new guidelines and new diagnostic methods coming into the arena necessitates the incorporation of new information in each new edition of a book. This facet has been addressed with the inclusion of recent information on the various aspects of microbiology, infectious diseases and immunology, in the fourth edition of the Textbook of Microbiology and Immunology ,which makes it one of the most authoritative and informative textbooks in medical microbiology.
The book is an effort to inform and engage a wide spectrum of readers including medical students , both undergraduates and postgraduates, and residents, and faculty. It aims to be a must-have companion book for graduate and advanced undergraduate as well as postgraduate students of medical microbiology, general and allied microbiology, and of immunology.
15.Vaccine Design Methods and Protocols, Volume 2. Vaccines for Veterinary Diseases
This volume provides a practical guide providing step-by-step protocol to explore vaccines for farm and companion animals, as well as for fish and insects. Divided into three volumes, Volume 2: Vaccines for Veterinary Diseases guides readers through veterinary vaccines, vaccines for poultry, vaccines for farm animals, and vaccines for veterinary parasites. 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 practical, Vaccine Design: Methods and Protocols, Second Edition, Volume 2: Vaccines for Veterinary Diseases aims to be a useful practical guide to researchers to help further their study in this field.
16.Viral Vectors for Vaccine Delivery
The book is essential for anyone interested in vaccine development, as it highlights the unique advantages of viral vector vaccines in triggering robust, long-lasting immunity and provides an in-depth exploration of the technology and advancements shaping the future of healthcare.
Viral vector vaccines have several unique advantages when compared to other vaccine platforms. These powerful vaccines are capable of triggering long-lasting cellular responses, such as cytotoxic T-lymphocytes, that eradicate virus-infected cells. Viral vector-based vaccines use a harmless virus to smuggle the instructions for making antigens from the disease-causing virus into cells, triggering protective immunity against them. In contrast to conventional antigen-containing vaccines, these vaccines use the body’s natural defense system to produce antigens by using a modified virus to deliver genetic code for an antigen. Viral Vectors for Vaccine Delivery provides a comprehensive overview of viral vectors and their applications in vaccine delivery. Its chapters explore various aspects of viral vector technology, from the basic principles of viral vector construction to the latest advancements in gene editing and manufacturing.
17.The Conquest of Viruses: A History of Viral Vaccines
This book guides through the fascinating history of viral vaccines, from the first primitive smallpox vaccination in the 18th century to the cutting-edge RSV formulation approved in 2023. Each chapter delves into the scientific, clinical, and social forces that led to the development of these life-saving medical innovations, highlighting the scientists who played pivotal roles. With a focus on making complex science accessible and history engaging, this book offers a comprehensive portrayal of virology, vaccinology and the interplay between science and society in shaping public health.
Readers will explore key concepts such as the evolution of vaccine technology over time, from cowpox material to mRNA vaccines, and a wide array of other topics, including the eradication of diseases through vaccines, the challenges of immunization against influenza, and the revolutionary impact of COVID-19 vaccination. The author, microbiologist Professor Wilson, provides expert analysis on how sociological factors influenced vaccine progress and gets to the bottom of the question of why there is still no vaccine for some critical diseases.
This book is a must-read for anyone with an interest in viruses and vaccines. Whether you're a researcher or simply fascinated by medical history, this book promises to be both informative and entertaining.
18.Recent Research on Human Papillomavirus (HPV) Infection and Vaccination
Persistent infection with high-risk human papillomavirus is associated with virtually all cervical cancers and a significant proportion of anogenital and oropharyngeal cancers. In recent years, significant progress has been made in cervical cancer prevention, especially in terms of the availability of prophylactic vaccines. However, the HPV vaccine has not yet achieved full coverage, and rates have dropped during the COVID-19 pandemic. -It is therefore necessary to strengthen HPV vaccine education, vaccination and early prevention, especially in situations such as in low-income countries, where there are still multiple issues related to its dissemination and acceptance. Meanwhile, exploring the various aspects underlying the mechanism of progression of HPV-associated malignancies, host immune system reactions toward HPV viruses as well as HPV vaccination is important for the development of specific therapeutics and vaccines against viral clinical manifestations.-Research areas of the Special Issue include discussing the knowledge and attitudes surrounding prophylactic HPV vaccination; vaccination implementation; effective instruments or interventions to improve public awareness of HPV vaccination; improving equity in HPV vaccination; the impact of the COVID-19 pandemic on HPV vaccination; host factors related to HPV infection, persistent, cervical intraepithelial neoplasia, and cervical cancer; co-infection of HPV with other pathogens; progression of HPV-associated malignancies; HPV and host–virus interaction; novel HPV vaccine development.
19.Trends in mRNA Vaccine Research
The authoritative guide to the revolutionary concept behind the successful Covid-19 vaccines.
In Trends in mRNA Vaccine Research, a team of distinguished researchers delivers a practical and up-to-date discussion of the biochemical and biomedical foundations of mRNA vaccines. They also explore the manufacturing conditions required for successful vaccine development and review recent progress in a variety of medical fields, including vaccines against pathogens like SARS-CoV-2, HIV, plasmodium, Mycobacterium tuberculosis, as well as anticancer vaccines.
20.Cancer Vaccination and Challenges Volume 1: Strategies for Therapeutic Cancer Vaccine Development
Strategies for Therapeutic Cancer Vaccine Development deals with different strategies of cancer vaccine development, focusing on techniques for the development of therapeutic cancer vaccines and the roles of tumor antigens, proteins/peptides, microbial genes, and stem cells for the development of vaccines for cancer management.
21.Cancer Vaccination and Challenges, Volume 2, Delivery Strategies for Cancer Vaccine
Delivery Strategies for Cancer Vaccine and Immunotherapy in Management of Various Carcinomas covers delivery strategies of cancer vaccines for the management of various forms of carcinoma, examining the prospects of delivering immuno-oncology therapies, focusing specifically on effective drug delivery strategies for the treatment of lung, prostate, and pancreatic carcinomas. Discusses delivery strategies of cancer vaccines for the management of various forms of carcinoma. Details the management of various carcinomas using vaccines, examining the prospects of delivering immuno-oncology therapies. Overviews the current vaccine systems, adjuvants, and delivery methods. Also focuses on therapeutic cancer vaccines.
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