coincidental. The act lists the program’s nine responsibilities4 with regard to intra-governmental coordination and coordination with stakeholders; most refer to the safety of vaccines and to adverse events. NVPO’s coordinating role was and remains an essential part of the vaccine safety system established by the act. This chapter examines how the plan could enhance the vaccine safety system; a more extensive discussion of the coordination required to implement the National Vaccine Plan is provided in Chapter 6.

The first part of this chapter provides an overview of four major components of the 1986 legislation and their current status: (1) vaccine safety surveillance and research; (2) information and communication about vaccine safety (discussed in Chapter 3); (3) the program of compensation for injuries thought to be caused by vaccine; and (4) the National Vaccine Program and Plan. The second part of the chapter is organized around four recommendations about priority actions for vaccine safety in the National Vaccine Plan.

In the history of vaccine development and regulation, concern has focused on both vaccine efficacy (and correlates of clinical protection) and vaccine safety. Both vaccine efficacy and vaccine safety are relative: no vaccine is 100 percent effective or 100 percent safe. The use of vaccination has reduced the incidence of disease (and therefore the immediate threat to any individual) and, concomitantly, the burden of fear of disease-related morbidity, disability, and death. The lower risk of disease has understandably led to higher expectations of vaccine safety. The story of polio vaccine illustrates the evolving nature of a vaccine’s risk-benefit balance and of the understanding of that balance as additional information on possible adverse events accrues and as disease incidence changes. In the 1950s when poliomyelitis was endemic in the United States, the benefit of live, attenuated poliovirus vaccine for the individual and the community was judged to greatly outweigh the risk of vaccine-associated paralysis, which occurred at a rate of about 1 case per 2.4 million doses distributed (CDC, 2009b). By 2000, when polio had been eliminated from the Western Hemisphere, this risk of vaccine-associated paralytic polio was judged no longer acceptable in the United States. An enhanced inactivated polio vaccine (IPV), first licensed by the Food and Drug Administration (FDA) in 1987, was ultimately recommended by the Advisory Committee on Immunization Practices (ACIP) in 2000 for exclusive use in routine immunization (CDC, 2000; Moylett and Hanson, 2004).

4

The nine responsibilities include vaccine research, vaccine development, “safety and efficacy testing of vaccines,” “licensing of vaccine manufacturers and vaccines,” “production and procurement of vaccines,” “distribution and use of vaccines,” “evaluating the need for and the effectiveness and adverse effects of vaccines and immunization activities,” “coordinating governmental and non-governmental activities,” and funding federal agencies in implementing the National Vaccine Plan.



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