Passive immunization entails administration of preformed antibody to a recipient. Passive immunization is indicated in the following general circumstances for prevention or amelioration of infectious diseases:

• When people are deficient in synthesis of antibody as a result of congenital or acquired B-lymphocyte defects, alone or in combination with other immunodeficiencies.


• Prophylactically, when a person susceptible to a disease is exposed to or has a high likelihood of exposure to that infection, especially when that person has a high risk of complications from the disease or when time does not permit adequate protection by active immunization alone.


• Therapeutically, when a disease is already present, antibody may ameliorate or aid in suppressing the effects of a toxin (eg, foodborne or wound botulism, diphtheria, or tetanus) or suppress the inflammatory response (eg, Kawasaki disease).

Passive immunization has been accomplished with several types of products. The choice is dictated by the types of products available, the type of antibody desired, the route of administration, timing, and other considerations. These products include Immune Globulin (IG) and specific ("hyperimmune") IG preparations given intramuscularly, Immune Globulin Intravenous (IGIV), specific (hyperimmune) IG given by the intravenous (IV) route (eg, Botulism Immune Globulin, Cytomegalovirus Immune Globulin [CMV-IGIV]), and antibodies of animal origin and monoclonal antibodies. Immune Globulin Subcutaneous (Human) has been approved for Treatment of patients with primary immune deficiency states.
Indications for administration of IG preparations other than those relevant to infectious diseases are not reviewed in the Red Book .

Whole blood and blood components for transfusion (including plasma) from US registered blood banks are released only after appropriate donor screening and testing for the presence of bloodborne pathogens, including syphilis, hepatitis B virus, hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, and HTLV-2; most donations for Trypanosoma cruzi (Chagas disease); and selected donations for CMV. Whole blood and blood components also are batch tested for West Nile virus; during an outbreak in a particular geographic area, units may be tested by individual unit nucleic acid amplification testing (see Blood Safety) and (see West Nile Virus). A similar array of tests is performed by US-licensed establishments that collect plasma used only to manufacture plasma derivatives, such as IGIV, IG, and specific immune globulins. IG and specific immune globulin preparations licensed in the United States have not been associated with transmission of any of these diseases. HCV transmission in 1994 was associated with administration of IGIV produced by a single manufacturer. The US Food and Drug Administration (FDA) now requires that IGIV and other immune globulin preparations for IV or intramuscular (IM) administration undergo additional manufacturing procedures that inactivate or remove viruses.