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 immunocompromi sed hosts interference with PPD test Consi der for PPD- negative children in prolonged contact with ineffectively treated adult TB patients or those with drug- resistant TB and for health care workers in high-risk settings. childhood TB, meningitis , and miliary disease Not for immunosupp ressed individuals Choler a Kille d whole bacteria Oral Travel ers to endemic areas; however, not recommende d for use by U.S. citizens because of extremely low risk. Not available in the U.S. 60– 85%, short duration Frequent fever and local reactions, pain, swelling Plague Inact ivated bacteria IM Labor atory workers; foresters in endemic areas; ?travelers 90 % antibody response; efficacy uncertain 10% local reactions; rare sterile abscess and hypersensitivity Rabies Inact ivated virus grown in cell culture (human diploid cell or purified chick embryo cell) or grown in cell culture and IM or ID Preex posure immunizatio n for travelers to high-risk countries, laboratory workers, and veterinarians or postexposure immunizatio Virt ually 100% for pre- or postexpos ure immunizat ion 25% local reactions; 6% of patients receiving booster doses may develop immune complex reactions with art hropathy, arthritis, angioedema adsorbed to aluminum phosphate n following a bite from a proven or suspected rabies- infected animal Yello w fever Live attenuated virus SC Travel ers to endemic areas; laboratory workers Hig h Rare associated neurologic complications (encephalitis, encephalopathy) or viscerotropic disease (fever; hypotension; respiratory, re nal, or hepatic failure; lymphocytopenia; thrombocytopenia ; and high risk of death) Japane se B encephalitis Inact ivated virus SC Travel ers to endemic areas 80– 90% Anaphylaxi s/severe delayed allergic reactions common; recipients should be observed for 10 days Typho id Purif ied Vi polysacchar ide (not for children <2 years of age) IM Travel ers ( ≥2 years old) to high- risk areas (southern Asia and other developing areas) except febrile 50– 80% Local reactions, mild patients Oral live attenuated Ty21a strain Oral Travel ers ( ≥6 years old) to high- risk areas as above, except within 24 h of antibiotic ingestion or in febrile patients 50– 80% Nil Note: SC, subcutaneous; BCG, bacille Calmette- Guérin; ID, intradermal; PPD, purified protein derivative; TB, tuberculosis. Source: Recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, American Academy of Pediatrics, American College of Physicians. . 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. 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. 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