. "2 History of the Special Immunizations Program and Lessons Learned from Occupational Immunization Against Hazardous Pathogens." Protecting the Frontline in Biodefense Research: The Special Immunizations Program. Washington, DC: The National Academies Press, 2011.
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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
and safety at Fort Detrick until 1972. Pathogen research conducted at Fort Detrick during the period of the offensive biowarfare program often involved high concentrations of microorganisms, aerosol challenge experiments involving laboratory animals, and pilot production of high-risk pathogens and toxins. Those operations placed laboratory workers at substantial risk for exposure and disease, particularly because the availability of treatments, including antibiotics and antiviral drugs, was severely limited at the time. Beginning in the 1950s, the United States operated a parallel program at Fort Detrick that conducted research on defensive measures against biological weapons (bioweapons) (Rusnak et al. 2004c). The United States maintained its offensive bioweapons program from 1943 to 1969, when it was discontinued under President Nixon; the defensive research program continued.
The Special Immunizations Program (SIP) at Fort Detrick began as an immunization program to provide an additional measure of protection of laboratory workers against occupational infections. A Special Procedures Section performed medical examinations on personnel assigned to work in the biowarfare sections, saved blood samples—which also allowed the detection of asymptomatic infections, and maintained records. In 1962, the Special Procedures Section became the SIP. Both licensed and investigational vaccines were used as part of the overall safety program to protect Fort Detrick personnel. Immunization of laboratory workers was mandatory,2 and the use of investigational vaccines was considered essential for occupational safety when licensed vaccines were not available.
The occupational health and safety of laboratory workers had the highest priority in the Fort Detrick industrial health and safety program, and procedures were implemented to support the biological safety (biosafety) goals. Annual medical examinations were provided for all Fort Detrick employees, and immunizations were provided for all laboratory personnel. The serum storage and collection program conducted annual serologic testing to detect seroconversion. Every infection was treated as laboratory-acquired until proved otherwise. All medical treatment and hospitalization were provided at no expense to infected workers. Reporting of exposures was encouraged and was not subject to disciplinary action. An active disease surveillance program provided a quick response to exposures that enabled both immediate medical care and the op-
Use of investigational vaccines in the SIP was considered outside Army Regulation AR 70-25, Use of Volunteers as Subjects of Research (U.S. Department of the Army 1990). That regulation, initially formulated in 1962 and last revised in 1990, states that voluntary informed consent is necessary in administering an investigational product to a human subject in the conduct of a research study. Additional information on the use of human subjects in Army research can be found in Chapter 24 of Medical Aspects of Biological Warfare, “Ethical and Legal Dilemmas in Biodefense Research” (U.S. Department of the Army 2007).