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Regulation and Testing of Vaccines in the US

## Vaccines are one of the most significant achievements of science and public health. As a result of successful vaccination programs and campaigns, many vaccine-preventable diseases are now uncommon in the United States. Vaccines for the prevention of infectious diseases are regulated by the U.S. Food and Drug Administration (FDA), and the legal framework for regulation is derived from Section 351 of the Public Health Service…

Economic Analyses of Vaccine Policies

At the time of writing this chapter, COVID-19 is the pandemic of the century, globally affecting macro and micro-economies. Recognition of the economic disruption from outbreaks on the regional level (Ebola viral disease) and global level (COVID-19) has led to justifying novel financial mechanisms to address the macroeconomic impact of uncontrolled communicable diseases. New national and international mechanisms of global collaborations have been established to mitigate…

Community Protection

Vaccines are given to people to protect them against disease. They are also given to reduce transmission of infection, thereby preventing disease even in nonvaccinated persons, and thus protecting communities. The extension of perspective from individuals to their communities is the business of public health. The use of an increasing number of different vaccines, in all populations of the world, represents a major, evolving, and highly…

Immunization in Low- and Middle-Income Countries

Since the late 1970s, childhood immunization has been one of the most effective and cost-effective public health preventive measures for all countries. Amongst low- and middle-income countries (LMICs) (a categorization based on income used by World Bank instead of “developing countries”), immunization prevented an estimated 37 million deaths from 2000 through 2019. The history of immunization in low-income countries can be traced back to the birth…

Immunization and Vaccine-Preventable Diseases in the Asia-Pacific Region

In the 20th century, the development, licensing, and implementation of vaccines as part of large, systematic immunization programs, aimed to address health inequities that existed globally. Yet access to vaccines that prevent life-threatening infectious diseases remains unequal among infants, children, and adults worldwide. This is a problem globally that governments and partner agencies are working hard to address. In recent years, the World Health Organization (WHO)…

Immunization in Europe

Europe is composed of a diverse group of countries and the extent of diversity depends on the definition of the boundaries of Europe. The European Union (EU) comprises 27 Member States of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. The EU together with the…

Immunization in the United States

A strong immunization program is critical to ensure vaccines are given at the recommended ages to all children, adolescents, and adults in the United States. The immunization system in the United States is a public- and private-sector partnership, including federal agencies, state and local health departments, healthcare providers, and vaccine manufacturers, that works toward common immunization goals and objectives. The U.S. immunization system has a formal…

Vaccination of Pregnant Women

WHY MATERNAL VACCINATION? The term “maternal immunization” has been used to describe vaccination of women prior to, during, and after pregnancy. In this chapter, we use the term maternal immunization to refer to vaccination of women during pregnancy and/or in the immediate postpartum period. Maternal vaccination can be used for the benefit of the mother, for the benefit of the infant, or for the benefit of…

Vaccines for Healthcare Personnel

Healthcare personnel (HCP) are at risk of exposure to infectious agents in the workplace setting. The risks and methods of preventing occupational acquisition of infection by HCP have been reviewed. Minimizing the risk of disease acquisition is based on correct and consistent adherence to five key recommended interventions: (a) adherence to Standard Precautions when providing patient care, especially the performance of appropriate hand hygiene before and…

Vaccines for International Travel

INTERNATIONAL TRAVEL People travel for many reasons, including tourism, business, educational experiences, or to flee from war, famine, or other intolerable situations. In 2019, international tourist arrivals reached 1.4 billion and were predicted by The World Tourism Organization to exceed 1.8 billion by 2030 before the COVID pandemic halted a 9-year trend of sustained growth in tourism. International migrants, a category of traveler not captured in…

Vaccination of Immunocompromised Hosts

INTRODUCTION Over the past decades, the number of immunocompromised patients has increased rapidly. These patients are vulnerable to several infections against which vaccines exist. New vaccines have been developed such as the subunit zoster vaccine. The two recent pandemics; the 2009 H1N1 influenza A pandemic and the ongoing COVID-19 pandemic have also shown the importance of rapid design of vaccination strategies in the immunocompromised patient populations.…

Technologies to Improve Immunization

NEW TECHNOLOGIES NEEDED TO REDUCE IMMUNIZATION LOGISTICS HURDLES Immunization can be described as the process of delivering carefully packaged antigen to the appropriate destination in a vaccine recipient to produce a desired immune response. In this sense, immunization programs are package delivery systems: they manage the flow of antigens, which are formulated in vaccines and packaged in different presentations, between the point of origin at the…

Genetic-Based Vaccine Vectors

INTRODUCTION The adoption and establishment of new vaccine platforms usually takes decades. The concept of delivering a recombinant virus whose payload is not the virus itself but rather the genetic instructions encoded within the viral genome originated in the 1980s with recombinant poxviral vaccine vectors. The approach mimicked live-attenuated vaccines (LAV), but provided a vision to replace the empiric and difficult strategy of viral attenuation through…

Technologies for Making New Vaccines

INTRODUCTION The technological approaches for making new vaccines have been growing rapidly in recent decades owing to significant advances in a broad range of interrelated fields, including next-generation sequencing and antibody repertoire analysis, molecular and structural biology, genetics (reverse vaccinology, synthetic biology), protein and polysaccharide chemistry, immunology, virology, bacteriology, fermentation, and macromolecular purification and formulation. An unprecedented leap forward was catalyzed by the COVID-19 pandemic, for…

Zoster Vaccines

Myron J. Levin, BA, MD Professor Pediatrics and Medicine University of Colorado Denver and Health Sciences Center, Aurora Colorado United States INTRODUCTION Herpes zoster (HZ), also called shingles, is a dermatomal vesicular disease. A dermatome is the area of skin innervated by one sensory nerve, and thus has bilateral symmetry and does not cross the midline. Fig. 66.1 depicts the right C4–C5 cervical nerve dermatome. The…

Zika Virus Vaccines

INTRODUCTION In 2016, the World Health Organization (WHO) declared Zika Virus (ZIKV) a Public Health Emergency of International Concern (PHEIC). This was in response to the association of ZIKV infection with an increased frequency of infants born with microcephaly and cases of Guillain-Barre syndrome (GBS) in adults. In response to this declaration, the development of vaccines for ZIKV proceeded with unprecedented speed. Multiple vaccine candidates utilizing…

Yellow Fever Vaccine

Yellow fever virus (YFV) is the prototype member of the Flaviviridae (Latin flavus , “yellow,” after the jaundice seen with the disease) family of viruses. The virus causes a viral hemorrhagic fever, a systemic illness characterized by high viremia, hepatic, renal, and myocardial injury; hemorrhage; and high lethality. A highly effective vaccine (17D), developed in 1936, is widely used to protect travelers to and residents of…

Varicella Vaccines

Maria. A. Nagel, MD Professor Neurology University of Colorado School of Medicine, Aurora Colorado United States Professor Ophthalmology University of Colorado School of Medicine, Aurora Colorado United States INTRODUCTION History of Disease Varicella zoster virus (VZV) is an exclusively human alphaherpesvirus that produces varicella (chickenpox) on primary infection, establishes latency in ganglionic neurons, then reactivates later in life to produce herpes zoster (HZ; shingles). Historically, varicella…

Typhoid Fever Vaccines

INTRODUCTION History of Disease Typhoid fever is an acute generalized infection of the mononuclear phagocyte system, intestinal lymphoid tissue, and gallbladder caused by Salmonella enterica serovar Typhi. A broad spectrum of clinical illness can ensue, with more severe forms being characterized by persisting high fever, abdominal discomfort, malaise, and headache. In the preantibiotic era, the disease ran its course over several weeks and was accompanied by…

Tuberculosis Vaccines

Bacille Calmette-Guérin (BCG) is currently the only licensed vaccine available against tuberculosis (TB). The vaccine has been given to over 4 billion people; yet, TB still poses a major public health threat globally. Approximately 25% of the world’s population has evidence of current or prior infection with Mycobacterium tuberculosis , with an estimated 10 million new cases of TB disease and 1.4 million deaths in 2019…