and is thus an additional benefit of MCM research. The data on vaccine safety and immunogenicity obtained by immunizing SIP participants with these IND vaccines help to provide the clinical basis for such uses.

The committee concluded that a systematic assessment of the need for new manufacturing of vaccines that are now in the SIP and a systematic assessment of potential candidates that could be entered into the SIP should be undertaken as a separate exercise. Vaccines and vaccine candidates developed in other countries should be considered as part of this assessment process for possible inclusion in the SIP.

Efforts to increase vaccine manufacturing capacity under HHS and DOD contracts appear to be under way. The committee encourages such efforts to include the SIP’s current needs and capacities in making decisions on expanding the manufacturing capacity of a comprehensive U.S. MCM effort. The committee also recognizes that manufacturing new stocks of existing SIP vaccines or incorporating some or all of the additional vaccines into the SIP must occur in the context of U.S. regulatory policy, as discussed in Chapter 4.

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