Parents who delayed and refused vaccine doses were more likely to have vaccine safety concerns and perceive fewer benefits associated with vaccines. Guidelines published by the American Academy of Pediatrics may assist providers in responding to parents who may delay or refuse vaccines.

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Immunizations are responsible for preventing death and disability from disease and are among the most cost-effective and widely used public health interventions. However, it is also recognized that no vaccine is perfectly safe or effective. Some people will experience side effects from vaccines, and a few may not experience a complete immunologic response to a vaccine, leaving them susceptible to disease. Sustaining high vaccine coverage rates may become more of a challenge as people question the limitations of vaccines and new parents no longer see or hear about the diseases from which vaccines protect them. In the future, maintaining public support for immunizations will be critical for preventing outbreaks of vaccine preventable diseases. In this chapter, we will focus on the importance of vaccine safety research; current gaps and limitations in knowledge in the field of vaccine safety; how vaccine safety is monitored; the vaccine injury compensation program; vaccine risk communication, and helpful resources for specific questions about vaccine safety. The Importance of Ongoing Vaccine Safety Research Vaccine adverse event reports include health events caused by vaccines (i.e., true adverse reactions) and those that are not caused by vaccines (associated only by coincidence). In maturing immunization programs, (figure 1) close monitoring and timely assessment of suspected vaccine adverse events are critical to prevent loss of confidence, decreased vaccine coverage, and return of epidemic disease. 1,2 This has been experienced in several countries for pertussis, 3 and more recently, diphtheria. 4 There are several key considerations for supporting and maintaining an active vaccine safety program. First, a higher standard of safety is generally expected of vaccines than of other medical interventions because, in contrast to most pharmaceutical products, which are administered to ill people for curative purposes, vaccines are generally given to healthy people to prevent disease. Public tolerance of adverse reactions related to products given to healthy people, especially healthy babies, is substantially lower than to products administered to people who are already sick. 5 This lower risk tolerance by the public for vaccines translates into a need to investigate rarer

Myocarditis was reported after smallpox vaccination in Europe and Australia, but no association had been reported with the US vaccine. We conducted surveillance to describe and determine the frequency of myocarditis and/or pericarditis (myo/pericarditis) among civilians vaccinated during the US smallpox vaccination program between January and October 2003. We developed surveillance case definitions for myocarditis, pericarditis, and dilated cardiomyopathy after smallpox vaccination. We identified 21 myo/pericarditis cases among 37,901 vaccinees (5.5 per 10,000); 18 (86%) were revacinees, 14 (67%) were women, and the median age was 48 years (range, 25-70 years). The median time from vaccination to onset of symptoms was 11 days (range, 2-42 days). Myo/pericarditis severity was mild, with no fatalities, although 9 patients (43%) were hospitalized. Three additional vaccinees were found to have dilated cardiomyopathy, recognized within 3 months after vaccination. We describe an association between smallpox vaccination, using the US vaccinia strain, and myo/pericarditis among civilians.

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