In 2004, when biodefense research was undergoing a rapid expansion, a U.S. Homeland Security Council Policy Coordinating Committee (HSC PCC) approved an expansion of the SIP in an effort to provide access to the program for government and civilian academic researchers. The SIP was to be funded by fully burdened contributions by the departments and agencies making use of the program according to percentage use. After 5 years of experience with the new arrangement, the Biomedical Advanced Research and Development Authority (BARDA), in the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS), asked the National Research Council to examine technical issues related to the HSC PCC recommendations regarding the expansion of the SIP, and to consider the larger context of vaccination for researchers who work with potentially hazardous biological agents (i.e., bacteria, viruses, and biological toxins) (see Box 1.1 for the full Statement of Task).

The committee formed by the National Research Council examined the history and current operation of the SIP as well as the principles of biosafety and historical data on exposures and laboratory-acquired infections (LAI) when working with hazardous pathogens and toxins. Those data demonstrate that although incidents of laboratory-acquired infections have decreased markedly over time as biosafety procedures, primary biocontainment systems, personal protective equipment, and facilities engineering have improved, the risk has not been reduced to zero, and infections do continue to occur sporadically. Researchers working with pathogens having a very low infectious dose (that is, those pathogens for which exposure to a very small quantity of the microbe can cause a disease) such as Venezuelan equine encephalitis virus, Brucella melitensis, Brucella abortus, Francisella tularensis, and Coxiella burnetii, may be particularly at risk. The committee also considered the regulatory frameworks under which SIP vaccines are administered and how additional vaccines now available in the United States or other countries might be considered for inclusion in the SIP. Finally, the committee considered other factors that might influence the development and manufacturing of new vaccines for the SIP.

As a result of its deliberations, the committee arrived at a series of findings and corresponding recommendations about the SIP and the general role of immunization in the context of hazardous pathogen research in the United States.

HISTORICAL VALUE OF THE SPECIAL IMMUNIZATIONS PROGRAM

The SIP has played a significant historical role in offering additional protection to laboratory workers involved in U.S. biodefense research. The lessons that have been learned through the program have advanced the practice of biosafety. Despite advances in other components of biosafety, immunization remains an integral component of an occupational safety program for people



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