possible that the loss of this resource would result in a reduction in the countermeasure research enterprise, given concerns about liability among employers and personal safety among laboratory workers. In addition, the committee noted that the SIP has value beyond individual worker immunization. The SIP serves as a resource on safety and immunogenicity information of all vaccines used in the program. Such data may have substantial value in a future national biodefense emergency. Publications arising from the SIP have also contributed to biosafety practices.

Feasibility: Challenging issues that need to be addressed within the current SIP, such as maintenance of vaccine stocks and compliance with IND regulatory requirements, could be avoided if the SIP were canceled. Although it may be feasible or even tempting to cancel the program, the committee concluded that the issue of the best way to protect the population of personnel working with hazardous pathogens as part of biodefense, MCM, and public health investments will remain and must be addressed in some fashion.

Conclusions: As discussed in Chapter 4, the committee noted that access to the licensed vaccines currently included in the SIP would be possible through other mechanisms were the SIP to be canceled. However, canceling the SIP would prevent access to the investigational vaccines it contains, which may offer an additional level of protection to researchers and remain an important component of an overall biosafety program. Despite potential cost savings and the possibility of avoiding challenging strategic questions about SIP governance and evolution, the committee strongly concluded that this option fails to meet an ethical duty to provide the option of immunization to personnel who work with hazardous pathogens where licensed or investigational vaccines are available. In addition, the SIP remains an essential component of our national countermeasure efforts.

6.2
CONCLUSION ON POTENTIAL OPTIONS FOR THE SIP

The committee concluded that a cooperatively governed SIP located at USAMRIID would constitute the most effective vaccination program for the community of military and civilian personnel working with hazardous pathogens while continuing to provide a manageable operational structure.



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