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Combination Vaccines

The combining of multiple antigens into a single vaccine is not a new concept; combination vaccines have long been a bedrock of immunization programs. Since the early 1990s, we have transitioned from a world in which DTP (diphtheria, tetanus, and pertussis vaccines combined) and MMR (measles, mumps, and rubella vaccines combined) represented essentially the only combination vaccines in use to one in which vaccines combining antigens…

Cholera Vaccines

HISTORY OF DISEASE Cholera is a rapidly dehydrating, watery diarrheal disease caused by intestinal infection with the bacterium Vibrio cholerae serogroups O1 and O139. Cholera has probably existed on the Indian subcontinent for thousands of years. Ancient manuscripts describe the physical symptoms of what we now recognize as cholera gravis: rapid-onset vomiting, abdominal pain, explosive diarrhea, dehydration, and death. Cholera is one of the dreaded epidemic…

Cancer Vaccines

Jay A. Berzofsky, MD, PhD Branch Chief Vaccine Branch Center for Cancer Research, National Cancer Institute, Bethesda Maryland United States INTRODUCTION Immunologists have long hoped to exploit the exquisite specificity of the immune system to eradicate cancers. Almost nothing is as specific as the immune system to distinguish cancer cells from normal cells, as it can detect single amino acid changes in a protein antigen, corresponding…

Biodefense Vaccines, Vaccines for Emerging Infectious Diseases, and Coalition for Epidemic Preparedness Innovations (CEPI)

BIODEFENSE AND SPECIAL PATHOGEN VACCINES Military personnel have the potential to be exposed to many infectious agents as endemic diseases and in their unnatural form as biological weapons. Increasingly, civilian populations may be targets for terrorist attacks using microorganisms (or their toxins), as was demonstrated by the purposeful dissemination of anthrax spores following ballistic attacks on the World Trade Center and the Pentagon in 2001. The…

Anthrax Vaccines

Anthrax, a zoonotic disease caused by Bacillus anthracis , has three forms: cutaneous, inhalational, and gastrointestinal. Mortality in untreated cutaneous cases is approximately 20%, but less than 1% if antibiotics are promptly given. Inhalational anthrax is almost 100% fatal if untreated, and gastrointestinal cases have an untreated mortality rate of 25–75%. Meningitis may be a complication of any of the three forms of disease. Natural cases…

Human Adenovirus Vaccines

HISTORY OF DISEASE In the 1950s, multiple researchers , identified a new agent as the cause of acute respiratory disease (ARD), pharyngitis, conjunctivitis, and pneumonitis. Soon afterward, these agents were recognized to be a related group of viruses and given their present name: human adenoviruses (HAdVs). WHY THE DISEASE IS IMPORTANT The HAdVs have often been noted to cause respiratory illness among U.S. military trainees ,…

General Immunization Practices

## Recommendations for immunization practices are based on scientific knowledge of vaccine characteristics, biology of immunization, epidemiology of specific diseases, and host characteristics. In addition, experience and judgment of public health officials and specialists in clinical and preventive medicine play a key role in developing recommendations that maximize benefits and minimize risks and costs associated with immunization. General guidelines for immunization practices are based on evidence…

Passive Immunization

Passive immunization, passive immunity, and passive immunotherapy all refer to the transfer of antibodies to an unprotected individual for the prevention or treatment of disease. The first formal demonstration of passive immunization involved successful treatment of diphtheria and tetanus in animal studies published in Deutsche Medizinische Wochenschrift ( German Medical Journal ) in 1890. The technique was quickly adapted to clinical use and as early as…

Vaccine Additives and Manufacturing Residuals in Vaccines Licensed in the United States

In addition to one or more immunogens, * * An immunogen is a preparation consisting of all or a portion of a disease-containing organism, or the nucleic acid that encodes one or more of the proteins from that organism, or all or a portion of a ­human tissue, and it is administered to an individual to induce an immune response to the immunogen for the treatment…

Evolution of Adjuvants Across the Centuries

Adjuvants are substances that are added to vaccine antigens to enhance and modulate the immunogenicity of its antigen. The first adjuvants developed focused on increasing antibody responses, and this has often been sufficient for the vaccines considered. During the last three decades, however, it has been realized that simply increasing antibody responses is not always sufficient for candidate vaccines to be effective. It has been observed…

Vaccine Manufacturing

The vast majority of the more than 5 billion doses of vaccines manufactured worldwide each year are given to perfectly healthy people. It is this fact that drives the requirements for vaccines to be among the most rigorously designed, monitored, and compliant products manufactured today. The ability to manufacture these vaccines safely and consistently is built on four competencies: 1 The manufacturing process that defines how…

The Vaccine Industry

The vaccine industry is composed of companies that are engaged in any of the following activities: research (including that performed in industry and biotech), development, manufacture, sales, marketing, or distribution of vaccines. They receive their revenue chiefly from sales of vaccine products or expectations thereof. The vaccine industry is relatively small compared with the pharmaceutical industry but growing. We estimate that total infectious disease vaccine sales…

Correlates of Protection

Peter Gilbert, PhD Professor Biostatistics Fred Hutchinson Cancer Center, Seattle Washington United States Research Professor Biostatistics University of Washington, Seattle Washington United States The determination of a correlate of protection (CoP) by a vaccine is often critical to its development, as its measurement permits a number of both use Peter B. Gilbert theoretical and practical extrapolations. Aside from the intellectual interest in identifying the immune response…

Non-specific Effects of Vaccines

INTRODUCTION In addition to protecting against their target disease, vaccines can induce changes in the immune system that have broader effects. As early as in the 1800s, it was noted that smallpox vaccination was associated with protection against unrelated infections. In the 1930s, the term “non-specific effects” (NSE) was used to describe the observation that the reduction in all-cause mortality in infants vaccinated with bacille Calmette-Guérin…

Vaccine Immunology

Generating vaccine-mediated protection is a complex challenge. Up to the year 2000, vaccines have largely been developed empirically, with little or no understanding of how they activate the immune system. Subsequently, the antigens to be included in vaccines such as meningococcal group B, subunit zoster, RTS/S malaria, human papillomavirus (HPV), and SARS-CoV-2 vaccines were defined based on their biological importance and presented in various ways to…

A Short History of Vaccination

Vaccination as a deliberate attempt to protect humans against disease has a short history when measured against the myriad years that humans have sought to rid themselves of plagues and pestilence. Only in the 20th century did the practice flower into the routine vaccination of large populations. Yet, despite its relative youth, the impact of vaccination on the health of the world’s peoples is hard to…

Nutrition

Food security remains a major challenge for communities that are dependent on climate-vulnerable subsistence farming and in settings of major humanitarian crisis including natural disaster, war and massive population displacement. According to the World Food Programme, in 2015 one in nine people on the planet went to bed hungry each night. The management of severe acute malnutrition (SAM) in children has been revolutionized by a technological…

Bites, stings, venoms, toxins

Venomous invertebrate and vertebrate animals are to be found anywhere in the world but are especially common in the tropics and subtropics, where they may be particularly hazardous. The following figures illustrate a few examples, including marine and terrestrial invertebrates and vertebrates. Although bites and stings are usually individual hazards and recognition depends upon understanding of the local epidemiology, the problem can take on public health…