In the late 1800s in the United States, efforts to combat infectious diseases such as cholera, malaria, diphtheria, smallpox, and tuberculosis were occurring in the midst of scientific advances that created new tools to combat these infectious diseases; this led to the establishment of more comprehensive public health programs and the development of municipal departments of health. The New York City (NYC) Department of Health, established in 1866 amidst fears of a new cholera epidemic in New York, was a leader in this arena. It opened a bacteriological laboratory in 1892 that became the first municipal laboratory in the world to provide for routine diagnosis of disease. This application of the new knowledge emerging in Europe at the turn of the nineteenth century regarding infectious diseases and their causative agents, as well as the emerging science of prevention, proved vital to the NYC Health Department's early successes in stemming the tide of epidemics and reducing deaths from common deadly infectious agents. A cornerstone of these efforts was combating diphtheria through the widespread distribution of diphtheria antitoxin (produced through the inoculation of horses in its bacteriology laboratory) (Junod, 2002); which, pivotally, included providing it free to the poor. The latter marked an important milestone in the history of vaccines and the development of public health disease prevention programs. As a result of the Department's widespread distribution of diphtheria antitoxin, the numbers of deaths due to diphtheria in New York City were cut in half by 1900. During this time period, the NYC Health Department went on to establish other key public health programs that led to further success. These included developing mandatory case-reporting requirements, conducting public education campaigns to enlist the public's help in reducing the spread of infectious diseases, creating a system of inspections of water, food and milk, and establishing a citywide baby-care program aimed at reducing the high child mortality rate (Jones, 2005).
During the same period, vaccine research and development was expanding worldwide, as evidenced by the sometimes competing work of Pasteur in France; Daniel Elmer Salmon and Theobald Smith on heat-killed vaccines for the US Department Agriculture; Henri Toussaint on anthrax; Richard Pfeiffer and Wilhelm Kolle in Germany and Almroth Wright in England on typhoid vaccines; Alexandre Yersin, Albert Calmette and Amedee Borelle on a plague vaccine for animals; and Waldemar Haffkine in India on a vaccine against human plague (Plotkin and Orenstein, 2004). Along with the immunobiologic discoveries that led to vaccine development, these research efforts also led to the development of epidemiologic methods to evaluate the safety and efficacy of new vaccines. Haffkine is credited with attempting to conduct the first controlled field trials with his cholera vaccine trials in the 1890s in India. However, the birth of the modern rigorous, controlled, large-scale field trial is considered to be the testing of the multivalent pneumococcal vaccine among 7730 army recruits during World War II. Ten years later, the field trial of the Salk polio vaccine involved the vaccination of more than 650,000 US children (Smith, 1990; Levine, 2004; Plotkin and Orenstein, 2004). The development of regulation to improve the safety, quality, and standardization of vaccines accompanied the advances in vaccine development at the turn of the twentieth century. The Biologics Control Act was passed by the US Congress in 1902 in response to the deaths of 13 children in St Louis and 9 children in New Jersey who received diphtheria immunizations contaminated with tetanus toxin (Junod, 2002; Milstien, 2004). The Act charged the Laboratory of Hygiene of the Marine Health Service (renamed the Hygienic Laboratory of the Public Health and Marine Hospital Service, and subsequently renamed the National Institute of Health in 1930) with regulating biologics. This work led to the development of vaccine standards and licensing requirements, including requiring that vaccines must be shown to be pure, safe, and efficacious; these provisions were formalized as part of the Public Health Service Act of 1944. Similar regulations were developed by the Food and Drug Administration (FDA) for drugs, which were codified in the Federal Food, Drug and Cosmetic Act of 1938. In 1941, Good Manufacturing Practice (GMP) was formally defined to ensure the safety and purity of medications during the manufacture process (Milstien, 2004). Following the Cutter Incident in 1955, in which incompletely inactivated polio vaccine caused polio disease and deaths, stricter standards for vaccine testing and manufacture were put into place and the Centers for Disease Control (CDC) developed a system for monitoring adverse events (Plotkin and Orenstein, 2004; Offit, 2005a). In 1972, the parallel regulation of biologics and drugs was brought together so that the provisions of the Food and Drug Control Act applied to vaccines as well. Since that time, the FDA has been responsible for the oversight and licensing of biological products including vaccines (Milstien, 2004).
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