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Chapter 116. Immunization Principles and Vaccine Use (Part 6)

Risk Assessment Vaccines are considered safe when the risk of use is judged to be acceptable in relation to the benefits. For vaccines given to healthy individuals for diseases that are no longer common, acceptable risks are set at very low levels—indeed, far lower than for most medical products. However, "safety" does not and cannot ever mean "zero risk." The determination of safety is thus based on a scientific assessment of the data and a considered judgment of all the issues involved, including benefits and risks. Communities and individuals may differ, both among themselves and from health care professionals,. | Chapter 116. Immunization Principles and Vaccine Use Part 6 Risk Assessment Vaccines are considered safe when the risk of use is judged to be acceptable in relation to the benefits. For vaccines given to healthy individuals for diseases that are no longer common acceptable risks are set at very low levels indeed far lower than for most medical products. However safety does not and cannot ever mean zero risk. The determination of safety is thus based on a scientific assessment of the data and a considered judgment of all the issues involved including benefits and risks. Communities and individuals may differ both among themselves and from health care professionals in how they perceive the risks benefits and acceptability of vaccines and in how they judge the amount of uncertainty that is tolerable. Some parent advocacy groups such as those that oppose mandatory vaccination feel that no amount of risk is acceptable especially for childhood vaccines. Sources of Immunization Recommendations Harmonized recommendations for vaccine use in the United States are developed by several professional groups. Schedules for immunization of children and adolescents and of adults are shown in Figs. 116-1 and 116-2 respectively. Vaccines recommended for special use are shown in Table 116-2. Table 116-2 Special Vaccines for Infants Children and Adults Vacci ne Vacc ine Type Rou te of Administr ation Indic ations Effi cacy Adverse Events Anthra x Inact ivated avirulent SC 6 doses primary plus annual For high risk of exposure e.g. persons 90 antibody response No serious adverse effects known bacteria booster in contact with or involved in manufacture of animal hides furs bone meal wool goat hair and military risk of biowarfare exposure efficacy uncertain Tuber culosis BCG Live bacteria attenuated Mycobacter ium bovis ID Not generally recommende d in U.S. because of low risk of TB and Var iable for adult pulmonary TB best used to prevent Regional adenitis disseminated BCG infection in .