Protecting the Frontline in Biodefense Research The Special Immunizations Program (2011) / Chapter Skim
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2 History of the Special Immunizations Program and Lessons Learned from Occupational Immunization Against Hazardous Pathogens
2 History of the Special Immunizations Program and Lessons Learned from Occupational Immunization Against Hazardous Pathogens
Pages 21-42
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, information on the history of Fort Detrick and on the historical offensive and defensive U.S. biological weapons programs may be found in Medical Aspects of Chemical and Biological Warfare (U.S.
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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.
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. 2.2 THE HISTORY OF VACCINE PRODUCTION FOR THE SPECIAL IMMUNIZATIONS PROGRAM 2.2.1 Origin and Evolution of the Salk Institute's Government Services Division The Salk Institute's Government Services Division (GSD)
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Because Merrell had the only facil ity capable of making vaccines that were not commercially available and had received similar Army contracts since 1960, the Army decided that the pro posed contract should be a sole-source contract. However, before the request for proposal's closing date, Merrell informed the Army that it was donating its Swiftwater facility, where the work would be performed, to the Salk Institute.
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1990 and 1991 Rift Valley fever, inactivated 1978, 1979, and 1989 Hepatitis A 1990 Venezuelan equine encephalitis, TC83, live, attenuated 1968, 1970, 1971, and 1972 Eastern equine encephalitis, inactivated 1969, 1970, and 1989 Western equine encephalitis, inactivated 1981 Venezuelan equine encephalitis, C84, inactivated 1980 and 1981 SOURCE: GAO 1991.
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In 1996, Salk lost its sole-source contract to develop vaccines, and in 1998, the Army awarded its biodefense vaccine contract to DynPort Vaccine Company; in September 1998, it was announced that the Salk GSD facility would be closed. DynPort manages countermeasures R&D through contractual mechanisms, including advanced development of a recombinant plague vaccine and a recombinant botulinum toxin vaccine, both originally developed at USAMRIID, but it does not main tain laboratory facilities of its own (DVC LLC 2011)
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, but defensive research continues 1970s Swiftwater facility donated to Salk Institute Salk Institute GSD in Swiftwater produces vaccines under Army contract 1980s DOD–FDA MOU allowing exempt use of investigational vaccines ends 1990s SIP vaccination at external sites ends Salk contract with Army ends Salk GSD closes Army vaccine contract established with DynPort 2.3 THE ROLE OF IMMUNIZATION IN RESEARCH WITH HAZARDOUS PATHOGENS AND LESSONS LEARNED 2.3.1 Laboratory Risk of Infection by Select Agents, Emerging Disease-Causing Pathogens, and Other Hazardous Pathogens History suggests that often the first case of a laboratory-associated infection (LAI) is associated with the discovery and isolation of the causative agent of an emerging infectious disease, and infections are also a risk during the period of follow-on research involving animal experimentation and larger volumes of the pathogen.
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2.3.2 Biosafety and the Role of Vaccines in Protecting Laboratory Workers Biosafety is the laboratory discipline that seeks to ensure the safe handling and containment of infectious pathogens and other hazardous biological mate rials. The objective of biosafety is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous pathogens and toxins.
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Dr. Wedum developed a risk assessment paradigm for identifying exposure and infection risks associ ated with a proposed research protocol and for selecting control measures that would provide for the safe handling of high-risk pathogens and toxins in the Fort Detrick biodefense program (Wedum et al.
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. The Fort Detrick industrial health and safety program developed the foun dation on which the principles of biosafety that protect laboratory workers, the environment, and the public from exposure to infectious microorganisms that are handled and stored in the laboratory are based: risk assessment, standard microbiological practices, containment, and facility safeguards.
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The 107 potential exposures to viral pathogens involved a larger number of viruses, with the most common potential exposures being to VEE virus (21) , Rift Valley fever virus (20)
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Between the isolation of yellow fever virus in 1927 and availability of a vaccine against this highly lethal disease in 1931, there were 32 LAIs (5 fatal) among laboratory workers.
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cProbable cause of limited protection associated with BCSs was failure to maintain user technical proficiency. tee examined the reports of several recent incidents of pathogen exposures in laboratory workers: • As referenced above, a laboratory worker at USAMRIID became in fected in 2000 with Burkholderia mallei and contracted glanders; a vaccine against B
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) 280 177 Coxiella burnetii 225 3 1 Francisella tularensis 181 10 Rickettsia prowazekii 72 Rickettsia rickettsii 40 1 Bacillus anthracis Brucella spp.
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. The CDC re ported the potential exposures of multiple clinical laboratory workers to attenuated Brucella abortus in 2007.
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The types and numbers of Select Agents in the loss and release reports are presented in Table 2.8. As observed in Table 2.7, reports of Select Agent releases increased from 2003 to 2009.
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Even in regulated research environments where hazardous pathogens and toxins are handled, the tables demonstrate that errors still occur and such incidents as failure of the primary containment system, spills, and sharps injuries can potentially expose personnel to infectious agents. Those data demonstrate that although incidents of LAI have decreased markedly as biosafety procedures have improved, risk has not been reduced to zero and some infections continue to occur.
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A recent discussion of biosafety has noted the difficulty in trying to evalu ate the effectiveness of various forms of biosafety practice, observing that "the regulations do not exactly specify the level of protection that they aim to afford, for example, in terms of diminishing exposure of the laboratory workers below a threshold level of infectivity. Furthermore, it is clear that the physical containment classes 1 to 4 afford increasing levels of containment, but it is not sufficiently clear and scientifically supported to what extent they provide effec tive protection with regard to prevention of infection of laboratory personnel, prevention of airborne escape, etc." (Kimman et al.
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. In sum, the Fort Detrick experience, the data provided by DSAT, and reviews of recent laboratory incidents demonstrate that exposures to infectious pathogens, and LAIs, can occur even in the most highly regulated research environments where high-risk pathogens, such as Select Agents, are handled.
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vaccine Eastern equine IND vaccines may Use of these IND vaccines should be carefully encephalitis, Venezuelan be available in considered and based on risk assessment; equine encephalitis, limited quantities Reference is made to the possible availability and Western equine for each of these from the SIP at USAMRIID encephalitis viruses viruses Not available at this timea Rift Valley fever virus Two vaccines under development Central European Vaccine is Use of this vaccine should be carefully availablec tickborne encephalitis considered if it is available and use is based virusesb on risk assessment; the efficacy of this vaccine against Russian spring–summer encephalitis virusb infections has not been established, but is probable based on published data Q fever Q fever vaccine Use of the Q fever vaccine should be restricted to laboratory workers who are at high risk of exposure and who have no demonstrated sensitivity to Q fever antigen. Reference is made to the possible availability from the SIP at USAMRIIDd Other infectious agents Licensed vaccines Commercial vaccines should be made available to workers to provide protection against the risk posed by occupational exposure to an infectious agent they will handlee SOURCE: CDC/NIH 2009.
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. 2.5 FINDINGS ON LABORATORY INFECTIONS From its review of the early history of the SIP and data on experience with laboratory infections caused by hazardous pathogens, the committee found the following: • Finding 1: The Special Immunizations Program has played an impor tant role in offering additional protection to laboratory workers who are involved in U.S.
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