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Protecting the Frontline in Biodefense Research: The Special Immunizations Program
infections, reports of Select Agent loss and release events, the history of biosafety practices, and lessons learned from occupational health and safety immunization programs such as the SIP. The committee noted that accidents and containment failures can occur even in highly regulated environments with trained personnel, and that some types of procedures (such as those involving sharps or aerosol exposures of animals), and some pathogens (such as those that have particularly low infectious doses) can present the greatest increased risk of infection to workers. The committee endorsed the concept that immunizations are not a substitute for other biosafety practices—such as appropriate training, personal protective equipment, and engineering controls—but that vaccines can serve as an important adjunct. The committee also endorsed the idea that immunizations should be offered to workers when safe and effective products exist and that employers have an ethical mandate to follow best practices in biosafety, including the provision of vaccines where warranted.
The committee considered the use of both licensed and Investigational New Drug (IND) status vaccines in the setting of occupational immunization. Licensed products have generally undergone larger-scale clinical trials, and their safety and efficacy profiles are well known. The IND vaccines used in the SIP remain in extended Phase II clinical trials. However, the clinical protocols under which these vaccines are administered have produced a wealth of data on human safety, immunogenicity, and probable efficacy, including long-term medical monitoring of SIP enrollees. The committee noted that publications analyzing data collected through the SIP have improved the understanding of immune responses to investigational vaccines and have helped to provide guidelines for the safe conduct of pathogen research and the management of laboratory infections. The committee views these publications as an important resource provided by the program, and encourages the SIP to analyze and make such data available to the research community. Although the IND vaccines currently used within the SIP were developed and manufactured largely in the 1970s and 1980s under standards that would probably be different from those applied today, the committee noted that these vaccines may be offered when beneficial to at-risk personnel and when options for immunization with newer or superior vaccines do not exist.
The committee emphasized the importance of conducting appropriate risk assessments and maintaining informed-consent procedures to ensure that IND vaccines are offered only to workers who are both at risk and medically eligible to receive such them. The committee endorsed the view that immunizations with SIP IND vaccines should be given on a voluntary basis. Immunizations with certain IND vaccines, such as those currently offered in the SIP, remain an important component of an overall biosafety program for laboratory workers who are at risk for exposure to hazardous pathogens.