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Special Immunizations Program, Report in Brief

Special Immunizations Program, Report in Brief

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Published by earthandlife
The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. This report examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.
The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. This report examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.

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Published by: earthandlife on May 11, 2011
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05/19/2012

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T
he SpecialImmunizationsProgram lls animportant niche in biosafety: it is the only program in the UnitedStates that makes investi-gational vaccinesavailable to laboratoryworkers who may beexposed to a range of viruses, bacteria, andtoxins. Its mission is toassure the safety andwell-being of program participants throughregular medical evaluations and the treatmentof occupational exposures to hazardous patho-gens, and to further medical research on thevaccines through the collection of safety andimmunogenicity data.The program is administered by the UnitedStates Army Medical Research and MaterialCommand, through its Medical MaterialDevelopment Activity and its Medical ResearchInstitute of Infectious Diseases (USAMRIID)in Fort Detrick, Maryland, and when rstlaunched provided vaccines to militarylaboratory workers. In the years following the2001 anthrax mailings the biodefense researcheld grew rapidly, and in 2004 a cost sharingagreement was reachedto expand the SpecialImmunizations Programto include additionalgovernment and civilian biodefense researchers.However, enrollment hasnot increased to antici- pated levels.The BiomedicalAdvanced Research andDevelopment Authorityof the U.S. Departmentof Health and HumanServices requested that the National ResearchCouncil convene a committee of experts toexamine issues related to the expansion of theSpecial Immunizations Program. The committeewas asked to consider the role of immunizations
The U.S. Army’s Special Immunizations Program is an important component of an overallbiosafety program for laboratory workers at risk of exposure to hazardous pathogens. Theprogram provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although rst established to servemilitary personnel, the program was expanded through a cost-sharing agreement in 2004 toinclude other government and civilian workers, reecting the expansion in biodefenseresearch in recent years. This report examines issues related to the expansion of the SpecialImmunizations Program, considering the regulatory frameworks under which the vaccinesare administered, how additional vaccines might be considered for inclusion in the Program,and the factors that might inuence the development and manufacturing of vaccines for theSpecial Immunizations Program.
Protecting the Frontline inBiodefense Research:The Special Immunizations Program
Credit: CDC/James Gathany
 Box 1. The Vaccines of the Special Immunizations Program
Currently, the Special Immunizations Programincludes investigational vaccines against botulism,equine encephalitis diseases (eastern, western, andVenezuelan), Rift Valley fever, Q fever, andtularemia. The program also provides Food andDrug Administration-licensed vaccines for anthrax,hepatitis B, Japanese encephalitis, rabies, smallpox,and yellow fever.
 
for at-risk laboratory workers, the regulatory frame-works under which Special Immunizations Programvaccines are administered, and how additionalvaccines currently available in the U.S. or in other countries might be considered for inclusion in theProgram. The committee also considered other factors that might inuence the development andmanufacturing of new vaccines for the SpecialImmunizations Program.
The Role of Immunizations in ProtectingWorkers
The committee found that, as biosafety proce-dures have improved, incidents of laboratory-acquired infections have decreasedmarkedly. However, biosafety procedures such asfollowing best laboratory practices, using personal protective equipment (such as gloves or biohazardsuits), and using engineering controls (such as biocontainment cabinets) have not reduced the risk of infection to zero, particularly when combinedwith human error. Infections continue to occur sporadically, and researchers working with patho-gens for which exposure to a very small quantity of the microbe can cause an infection, for exampleVenezuelan equine encephalitis virus, may be particularly at risk. Therefore, the committee foundthat although immunization should never be asubstitute for careful adherence to biosafety best practices, vaccines remain an important additionalcomponent in ensuring the occupational safety of  biodefense researchers.
The Use of Investigational New Drug StatusVaccines
The vaccines offered through the SpecialImmunizations Program include both Food andDrug Administration-licensed products and vaccinesthat have not been licensed and remain under Investigational New Drug status.Licensed products have generally undergonelarge-scale clinical trials and the safety and efcacyof the vaccines is well known; on the other hand,investigational vaccines are still in clinical trials.From the laboratory worker’s perspective, even anunlicensed vaccine with a good safety record andstrong history of eliciting an immune response toa hazardous pathogen might be expected to provid additional protection, even though its protective efcacy in humans cannot yet be consid-ered known. Furthermore, using investigationalvaccines in the Special Immunizations Program permits the ongoing collection of data on thesafety and immunogenicity of vaccines, infor– mation that could be of substantial value to other researchers working on medical countermeasuresdevelopment or if, in a future national biodefenseemergency, there were a need to make the vaccinewidely available.The use of investigational vaccines in the SpecialImmunizations Program is not ideal for severalreasons. The investigational vaccines currently usedwithin the Special Immunizations Program werelargely developed and manufactured in the 1970sand 1980s, under standards that are different fromthose in use today. Although the vaccines in theSpecial Immunizations Program were completelyre-tested from 2000-2003 under current standards,the vaccine composition and immune responses of some investigational vaccines is less than optimal.Because they must be administered as part of clinicaltrials, using them also presents signicant cost andregulatory burdens to the program.However, the committee noted that for many pathogens, newer or superior vaccines do not yetexist. In these cases, immunization with investiga-tional vaccines continues to offer benets to at-risk  personnel. The use of investigational vaccines must be evaluated on a case-by-case basis along with anappropriate risk analyses that consider the types of work being performed by the individual, the indi-vidual’s medical history, and other factors.Performing this case-by-case evaluation and offering
 Box 2. The Supply of Special Immunizations Program Vaccines
The bulk of the investigational vaccines availablethrough the Special Immunizations Program weremanufactured under military contracts at the Salk Institute vaccine production plant in Swiftwater, PA inthe 1960s-1980s. Since the closure of the Salk InstituteGovernment Services Division in 1998, no new lots of these vaccines have been produced.Conservative estimates suggest that the supply of theseinvestigational vaccines is sufcient to meet programneeds (estimates range from 10–11 years for Rift Valleyfever vaccine to 73 years for Venezuelan and easternequine encephalitis vaccines using the current vaccinelots; additional lots of vaccine would also be available if needed). As vaccines against hazardous agents of interest to the Special Immunizations Program have become licensed (e.g. Japanese encephalitis, hepatitisB, rabies, anthrax, smallpox, and yellow fever vaccines)the program has continued to purchase these vaccinesand administer them to eligible personnel.
 
the investigational immunizations on avoluntary basis, subject to informedconsent, will help ensure that immuni-zations are available for those researchersfor whom the benets of vaccinationoutweigh the risks. As newer, safer, or improved vaccines become availableagainst pathogens in the SpecialImmunizations Program, these replace-ment vaccines should be incorporatedinto the program to phase out the older or less effective ones.
Extension of the Program to MeetCivilian Needs
The committee found that the SpecialImmunizations Program has generallyfunctioned well for military researchers.The U.S. Army Medical Research and MaterialCommand has the facilities, personnel, operating procedures and infrastructure to successfullyadminister, monitor, and document immunizationsgiven through the Program.However, the Program has not met the antici- pated need of researchers beyond the military, particularly laboratory workers involved in civilian biodefense countermeasures and public healthresearch. When the program expanded in 2004, itwas estimated that 1000 to 5000 workers might becandidates for vaccination, but enrollment in the program has remained relatively constant at about600 participants per year. This may reect the costto participate in the program, which is about $10,000to $15,000 per year, in addition to the cost of travelto Fort Detrick in order to receive the vaccinationsand medical monitoring.Encouraging agency contract and grant awardsto cover the costs of immunizing personnel wouldhelp reduce the burden of cost borne by institutionsworking on government supported programs.Furthermore, establishing a limited number of satellite clinic locations could reduce travel costsfor program participants.The static enrollment may also indicate that theProgram does not offer vaccines against the agentsof most interest to civilian biodefense researchers.The committee noted that vaccines offered throughthe current program largely reect the needs and priorities of historical Department of Defense biodefense research programs, which may not matchcurrent or future biodefense needs.Developing a system to enable SpecialImmunizations Program stakeholders, including theDepartment of Defense, Department of Health andHuman Services, and Department of Agriculture, toregularly review and assess the vaccines included inthe program, the pathogens against which thesevaccines are directed, and the existence and stageof development of new vaccines, would help ensurethat the program reects evolving civilian andmilitary biodefense priorities. For example, vaccinesof potential value to the Special ImmunizationsProgram are either under development in the U.S.or abroad or already licensed for use in other countries. In addition, as research on medicalcountermeasures to hazardous pathogens continues,new vaccines may become available.
Vaccine Development
Prioritizing a list of pathogens for inclusion inthe Special Immunizations Program would helpensure that the program remains relevant. Thecommittee concluded that the list should be basedon the characteristics of the agent, such as theinfectious dose, transmission potential, and fatalityrate; and the characteristics of the threat, such as the presence of the pathogen on government threat lists,if the pathogen is the subject of active research, andthe current availability of vaccines.Pharmaceutical companies usually develop andobtain licenses for new vaccines. However, thevaccines offered in the Special ImmunizationsProgram typically have little or no commercial value,and therefore are of little interest to industry. Thecommittee noted procurement initiatives put forward by the Department of Health and Human Servicesand the Department of Defense to support industry partnerships in vaccine development, and encour-aged the federal agencies, when making major U.S.
 Box 3. Who Uses the Special Immunizations Program?
Approximately 600 participants per year are enrolled in the Program.About 60% of these participants work at USAMRIID and the other 40%at other agencies within the Department of Defense, other governmentalagencies, and external organizations. The types of workers for whomSpecial Immunizations Program vaccination may be most relevantinclude not only laboratory workers, but also:
animal technicians working to develop next generation medicalcountermeasures for military and civilian use
 personnel working on biodefense vaccines, or human and veteri-nary vaccines against zoonotic diseases—diseases that can betransmitted between humans and animals
scientists and laboratory technicians engaged in eld studies of theecology and epidemiology of hazardous pathogens
scientists in public health diagnostic laboratories

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