human clinical trials on vaccines against highly hazardous pathogens can lead to regulatory and manufacturing challenges. The vaccines required for the SIP have no or extremely limited commercial value and do not attract interest from the biopharmaceutical industry. As a result, there is a need to explore regulatory and manufacturing options. Furthermore, there is a need to consider whether additional vaccines already in use or in development should be considered for inclusion in an expanded SIP.

The following two chapters discuss some of these challenges and options in greater detail in two primary areas: (a) current regulatory pathways applicable to vaccines and how these might apply to the use of vaccines within the SIP (Chapter 4), and (b) the state of vaccine manufacturing and options for the evolution of vaccines currently used in the SIP (Chapter 5).

4.1
OVERALL REGULATORY FRAMEWORK FOR VACCINES

In the United States, all vaccines, including those in the SIP, are regulated as biologics by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA). A single set of basic regulatory approval criteria apply to all human vaccines, regardless of the technology used to produce them. CBER’s current legal authority for the regulation of vaccines derives primarily from Section 351 of the Public Health Service (PHS) Act and from certain sections of the Federal Food, Drug and Cosmetic (FD&C) Act. The PHS Act is implemented through regulations codified in Title 21 of the Code of Federal Regulations (CFR), Parts 600 through 680, which contain regulations specifically applicable to vaccines and other biologics. In addition, because a “vaccine” meets the legal definition of a “drug” under the FD&C Act, sponsors must also comply with current Good Manufacturing Practice (cGMPs) regulations in 21 CFR Parts 210 and 211, and, for all human testing prior to licensure, the Investigational New Drug (IND) regulations in 21 CFR Part 312. Most of the vaccines included in the SIP are directed against pathogens that are now identified as Select Agents (42 CFR Part 72; 42 CFR Part 73; 7 CFR Part 331; 9 CFR Part 121), which can cause life-threatening and/or fatal illness in exposed laboratory workers. As described previously in Chapter 3, the SIP presently consists of eight U.S. licensed vaccines, seven that are administered under active INDs held by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), and one administered under an active IND held by the Centers for Disease Control and Prevention (CDC). Given the large expansion in laboratory research for Select Agents and other existing or emerging pathogens during the past decade, the number of vaccines that might be included in the SIP is expected to grow.

Given this overall regulatory framework, the current objectives of the SIP,



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