Protecting the Frontline in Biodefense Research The Special Immunizations Program (2011) / Chapter Skim
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1 Introduction
1 Introduction
Pages 7-20
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• To collect vaccine safety and immunogenicity data to further medical research. The SIP vaccines augment the protection provided by laboratory best practices, engineering controls, and personal protective equipment for working with hazardous pathogens and toxins.
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Department of Health and Human Services (HHS) , asked the National Research Council to examine technical issues related to the HSC PCC recommendation for the expansion of the SIP in the larger context of immunization of researchers working with potentially hazardous pathogens and toxins.
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Shortly after the September 11, 2001, attacks, the United States received a new impetus to support and conduct pathogen research when a second set of attacks occurred, this time involving the bacterium Bacillus anthracis, the etiologic agent of the disease anthrax. Since then, the nation's capacity to conduct pathogen research has expanded substantially.
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has supported the development of 11 Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases (RCEs) and 12 Regional Biocontainment Laboratories (RBLs)
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Before 2001, the statute governed primarily the transfer of biological pathogens and toxins between research laboratories. The act directed the secretary of HHS and the secretary of USDA to regulate the transport of biological agents that have the potential to pose severe threats to public, animal, or plant health and safety through their use in bioterrorism.
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• Directs the secretaries of HHS and USDA to review and publish the Select Agents list biennially, making revisions as appropriate to protect the public. • Requires the secretaries of HHS and USDA to impose more detailed and different levels of security for different Select Agents on the basis of their assessed level of threat to the public.
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9 Pathogens most often considered as posing the greatest human health threats include Bacillus anthracis (anthrax) , Clostridium botulinum toxin, Francisella tularensis (tularemia)
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Burkholderia pseudomallei (formerly Pseudomonas Coccidioides posadasii/Coccidioides immitis Conotoxins pseudomallei) Hendra virus Coxiella burnetii Crimean-Congo hemorrhagic fever virus Nipah virus Diacetoxyscirpenol Rift Valley fever virus Eastern equine encephalitis virus Venezuelan equine encephalitis virus Ebola virus USDA SELECT AGENTS AND TOXINS Francisella tularensis Lassa fever virus African horsesickness virus Marburg virus African swine fever virus Monkeypox virus Akabane virus Reconstructed replication-competent Avian influenza virus (highly pathogenic)
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1.3 CHARGE TO THE COMMITTEE Given both the substantial expansion in research with hazardous patho gens since 2001 and current efforts to review national biodefense and infectious disease countermeasures programs, the HHS BARDA asked the National Re search Council's Board on Life Sciences to examine the SIP and its role in helping to protect researchers who work with highly hazardous pathogens. The SIP, administered by USAMRIID, provides access to licensed and investigational vaccines against selected highly hazardous pathogens and toxins for scientists, technicians, and other workers who may be exposed to these microorganisms as part of their employment.
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-- Lassa fever virus Listeria monocytogenes Bunyaviruses Campylobacter jejuni -- Hantaviruses Yersinia enterocolitica -- Rift Valley fever virus -- Viruses (Caliciviruses, hepatitis A) Flaviviruses -- Protozoa -- Dengue viruses Cryptosporidium parvum Filoviruses Cyclospora cayatanensis -- Ebola virus Giardia lamblia -- Marburg virus Entamoeba histolytica Toxoplasma spp.
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aNIAID Category C Antimicrobial Resistance -- Sexually Transmitted Excluded Organisms Bacterial vaginosis, Chlamydia trachomatis, cytomegalovirus, Granuloma inguinale, Hemophilus ducreyi, hepatitis B virus, hepatitis C virus, Herpes simplex virus, human immunodeficiency virus, human papillomavirus, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis SOURCE: NIAID 2009. A committee of experts in such fields as pathogen research, infectious diseases, vaccine effectiveness and safety, vaccine manufacturing, regulatory affairs, biosafety and laboratory operations, and biological ethics (bioethics)
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in 2004 to expand the United States Army Medical Research Institute of Infectious Diseases' (USAMRIID's) Special Immunizations Program (SIP)
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Army's historical bioweapons program at Fort Detrick, MD, but it now serves both civilian and military personnel and scientists conducting biodefense research at facilities other than USAMRIID. Chapter 2 also presents information on the frequency of laboratory exposures and the lessons that have been learned from experience in providing vaccina tions to workers engaged in hazardous-pathogen research.
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