General Recommendations on Immunization mic adverse reactions following live vaccines are usually 1.e fter an inc bation per A AlV ma e an symptoms (like a cold)but not influenza-like symptoms. Vaccine Adverse Reactions A third type of vaccine adverse reaction is a severe (anaph llergic rea ·Allergic d i allergic reaction.The be caus vaccine antige al iotic used to threatening.Fortunately,they are very rare,occurring at a rate of less than one in half a million dose The risk of an inimized by good screening prior to vac nister vac ave an emergency proto Reporting Vaccine Adverse Events From 1978 to 1990.cDC conducted the monite for Adverse events followins ng System Immunization（MSAEFI)）in the public sector.In 1990,MSAEFI was replaced by the Vaccine Adverse Events Reporting System(VAERS),which of any vaccine Providers should report a clinically significant adverse event 以so ons and is800 aers.h VR the now accepts online system Contraindications and Precautions to Vaccination Contraindications and precaution ic on gene Mos contraindications and pre cautions are temporary,and the vaccine can be given at a later time. Contraindication A contraindication is a condition in a recipient that It is a condition in the repet fhe vac ne,not with the vacine were given m e sulting adverse reaction usly 16
2 Systemic adverse reactions following live vaccines are usually mild, and occur a week or two after the vaccine was given (i.e., after an incubation period of the vaccine virus). LAIV replicates in the mucous membranes of the nose and throat, not in the lung. As a result, LAIV may cause upper respiratory symptoms (like a cold) but not influenza-like symptoms. A third type of vaccine adverse reaction is a severe (anaphylactic) allergic reaction. The allergic reaction may be caused by the vaccine antigen itself or some other component of the vaccine, such as cell culture material, stabilizer, preservatives, or antibiotic used to inhibit bacterial growth. Severe allergic reactions to vaccines may be lifethreatening. Fortunately, they are very rare, occurring at a rate of less than one in half a million doses. The risk of an allergic reaction can be minimized by good screening prior to vaccination. All providers who administer vaccines must have an emergency protocol and supplies to treat anaphylaxis. Reporting Vaccine Adverse Events From 1978 to 1990, CDC conducted the Monitoring System for Adverse Events Following Immunization (MSAEFI) in the public sector. In 1990, MSAEFI was replaced by the Vaccine Adverse Events Reporting System (VAERS), which includes reporting from both public and private sectors. Providers should report any clinically significant adverse event that occurs after the administration of any vaccine licensed in the United States. Providers should report a clinically significant adverse event even if they are unsure whether a vaccine caused the event. The telephone number to call for answers to questions and to obtain VAERS forms is 800–822–7967, or visit the VAERS website at http://vaers.hhs.gov. VAERS now accepts reports of adverse events through their online system. (See Chapter 4, Vaccine Safety.) Contraindications and Precautions to Vaccination Contraindications and precautions to vaccination generally dictate circumstances when vaccines will not be given. Most contraindications and precautions are temporary, and the vaccine can be given at a later time. A contraindication is a condition in a recipient that increases the chance of a serious adverse reaction. It is a condition in the recipient of the vaccine, not with the vaccine per se. If the vaccine were given in the presence of that condition, the resulting adverse reaction could seriously 16 General Recommendations on Immunization
General Recommendations on Immunization harm the recipient.For instance,administe ccine to a￥ ro with a true anaphvlactic allergy to egs 2 could cause serious illness or death in the recipient.In ger vaccines should not be administered when a contraindication condition is present. Precaution A precaution is similar to a indication.A pre cautior naeipnt that abiliry of the vac increthchrsverity of cine to immunity to measles from a blood transfusion).Injury could Ce28oeoaebo result,but the chance of this happening is less than with a contraindication.In general,vac cines are deferred when a is present. owever, hn cell or acellular pertussis vaccine is considered a precaution to subsequent doses of pediatric pertussis vaccine.But if the child were at high risk of pertussis exposure (e.g.during a pertussis outbreak in the Contraindications and Precaution There are very few true contraindication and precaution conraindications to conditions.Only two of these conditions are generally eaacm Four conditions are further doses of pediatric p ecautions to temperature greater than 105F collapse or shock-like state (hypotonic hyporesponsive episode),persistent inconsolable crying lasting 3 or more hours occurring within 48 hours of The ocurrence of one of thes events aution to pertussis Contraindications and Precaution Condition Live Inactivated T conditions are temporary contraindications to vaccination gy to c nent with live vaccines: ession moderate or severe acute illness (all vaccines),and rec raiadoingkadmothrNR 17
2 harm the recipient. For instance, administering influenza vaccine to a person with a true anaphylactic allergy to egg could cause serious illness or death in the recipient. In general, vaccines should not be administered when a contraindication condition is present. A precaution is similar to a contraindication. A precaution is a condition in a recipient that might increase the chance or severity of a serious adverse reaction, or compromise the ability of the vaccine to produce immunity (such as administering measles vaccine to a person with passive immunity to measles from a blood transfusion). Injury could result, but the chance of this happening is less than with a contraindication. In general, vaccines are deferred when a precaution condition is present. However, situations may arise when the benefit of protection from the vaccine outweighs the risk of an adverse reaction, and a provider may decide to give the vaccine. For example, prolonged crying or a high fever after a dose of whole-cell or acellular pertussis vaccine is considered a precaution to subsequent doses of pediatric pertussis vaccine. But if the child were at high risk of pertussis exposure (e.g., during a pertussis outbreak in the community), a provider may choose to vaccinate the child and treat the adverse reaction if it occurs. In this example, the benefit of protection from the vaccine outweighs the harm potentially caused by the vaccine. There are very few true contraindication and precaution conditions. Only two of these conditions are generally considered to be permanent: severe (anaphylactic) allergic reaction to a vaccine component or following a prior dose of a vaccine, and encephalopathy not due to another identifiable cause occurring within 7 days of vaccination. Four conditions are considered permanent precautions to further doses of pediatric pertussis-containing vaccine: temperature greater than 105o F, collapse or shock-like state (hypotonic hyporesponsive episode), persistent inconsolable crying lasting 3 or more hours occurring within 48 hours of a dose, or a seizure, with or without fever, occurring within 3 days of a dose. The occurrence of one of these events following DTaP vaccine is not a precaution to pertussis vaccination of an adolescent or adult. Two conditions are temporary contraindications to vaccination with live vaccines: pregnancy and immunosuppression. Two conditions are temporary precautions to vaccination: moderate or severe acute illness (all vaccines), and recent receipt of an antibody-containing blood product (MMR and varicella only). 17 General Recommendations on Immunization
General Recommendations on Immunization Allergy A sever e (anaphylactic)allergic reaction following a dose of vaccine will almost always contraindicate a subsequent dose vere allergies are those that are mediated bytlgt.occut within minutes or hours ofreceiving the reneralized urticaria (hives).swelline of the mouth and throat.difficulr breathing.heeng hypotension,or shock.With appropriate screening these reactions are very rare following vaccination. A table listin ts is included in ar ndix B protein,antibiotics,preservatives,or stabilizers.The most common animal protein allergen is egg protein found in ing embryona en eggs (e.g. ry,person ons with histories of ing persons wl her they can eat and influenza vaccines. Several studies have shown that children who have a s to ne. vaccine vin in chicle measl pfihrobnPs not actually in eggs.It app s that gelatin not egg.might be the cause of allergic reactions to MMR.As a result,in 198.the mmittee on Immur severe eg alle n may be Persons wl ctions to neomvciihl not receive these vac e(cell-mediated)immune response,rather than anaphylaxis.A history of delayed-type adiniomofieicthconainticaioato ese vaccines Latex is liquid sap from the commercial rubber tree.latex contains naturally。 currin s used to produce medical gloves,catheters,and other products.Dry 18
2 Allergy A severe (anaphylactic) allergic reaction following a dose of vaccine will almost always contraindicate a subsequent dose of that vaccine. Severe allergies are those that are mediated by IgE, occur within minutes or hours of receiving the vaccine, and require medical attention. Examples of severe allergic reactions are generalized urticaria (hives), swelling of the mouth and throat, difficulty breathing, wheezing, hypotension, or shock. With appropriate screening these reactions are very rare following vaccination. A table listing vaccine contents is included in Appendix B. Persons may be allergic to the vaccine antigen, animal protein, antibiotics, preservatives, or stabilizers. The most common animal protein allergen is egg protein found in vaccines prepared using embryonated chicken eggs (e.g., yellow fever and influenza vaccines). Ordinarily, persons who are able to eat eggs or egg products can receive vaccines that contain egg; persons with histories of anaphylactic or anaphylactic-like allergy to eggs or egg proteins should not. Asking persons whether they can eat eggs without adverse effects is a reasonable way to screen for those who might be at risk from receiving yellow fever and influenza vaccines. Several studies have shown that children who have a history of severe allergy to eggs rarely have reactions to MMR vaccine. This is probably because measles and mumps vaccine viruses are both grown in chick embryo fibroblasts, not actually in eggs. It appears that gelatin, not egg, might be the cause of allergic reactions to MMR. As a result, in 1998, the Advisory Committee on Immunization Practices removed severe egg allergy as a contraindication to measles and mumps vaccines. Egg-allergic children may be vaccinated with MMR without prior skin testing. Certain vaccines contain trace amounts of neomycin. Persons who have experienced anaphylactic reactions to neomycin should not receive these vaccines. Most often, a neomycin allergy reaction is a contact dermatitis, a manifestation of a delayed-type (cell-mediated) immune response, rather than anaphylaxis. A history of delayed-type reactions to neomycin is not a contraindication for administration of these vaccines. Latex is liquid sap from the commercial rubber tree. Latex contains naturally occurring impurities (e.g., plant proteins and peptides), which are believed to be responsible for allergic reactions. Latex is processed to form natural rubber latex and dry natural rubber. Dry natural rubber and natural rubber latex might contain the same plant impurities as latex but in a lesser amounts. Natural rubber latex is used to produce medical gloves, catheters, and other products. Dry 18 General Recommendations on Immunization
General Recommendations on Immunization natural rubber is used in s s,and and synthetic latex also are used in medical gloves,syringe leSiandmaltopeTSatcticxnhbrinderthe the the ext an lergi The most common type of latex sensitivity is contact-type (type 4)a lergy,usu yaiarultofpolongedcontactwit ing g procedures are rare.Only one report of an allergic reaction re (ananbylactic)allerey to late e出 ed unless the benefit of an allergic reaction er tha 1 plied in vials nges that ves) natural rubber or natural rubber latex can be administered. Pregnancy The concern about vaccinating pregnant women is with infection of the fetus and is theoretical.Only smallpox vaccinia)vac o caus e re al injury a cine Since inactivated vaccines cannot replicate,they cannot cause fetal infection.Inactivated vaccines should be women should receive MMR and varicella vaccines and may receive LAIV,if eligible. Immunosuppression Live vaccines can cause severe or fatal reactions in immunosuppressed persons due to uncontrolled replication Imm suppression y munodcncy B-cell deficiency may receive varicella vaccine.Inactivated ·Leukemia or lymphoma .Generalized malignancy 19
2 natural rubber is used in syringe plungers, vial stoppers, and injection ports on intravascular tubing. Synthetic rubber and synthetic latex also are used in medical gloves, syringe plungers, and vial stoppers. Synthetic rubber and synthetic latex do not contain natural rubber or natural latex, and therefore, do not contain the impurities linked to allergic reactions. The most common type of latex sensitivity is contact-type (type 4) allergy, usually as a result of prolonged contact with latex-containing gloves. However, injection-procedure–associated latex allergies among diabetic patients have been described. Allergic reactions (including anaphylaxis) after vaccination procedures are rare. Only one report of an allergic reaction after administration of hepatitis B vaccine in a patient with known severe allergy (anaphylaxis) to latex has been published. If a person reports a severe (anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain natural rubber should not be administered unless the benefit of vaccination clearly outweighs the risk of an allergic reaction to the vaccine. For latex allergies other than anaphylactic allergies (e.g., a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain dry natural rubber or natural rubber latex can be administered. Pregnancy The concern about vaccinating pregnant women is with infection of the fetus and is theoretical. Only smallpox (vaccinia) vaccine has been shown to cause fetal injury. However, since the theoretical possibility exists, live vaccines should not be given to women known to be pregnant. Since inactivated vaccines cannot replicate, they cannot cause fetal infection. Inactivated vaccines should be administered to pregnant women for whom they are indicated. Susceptible household contacts of pregnant women should receive MMR and varicella vaccines and may receive LAIV, if eligible. Immunosuppression Live vaccines can cause severe or fatal reactions in immunosuppressed persons due to uncontrolled replication of the vaccine virus, particularly vaccinia and oral polio vaccine virus (and rarely measles and varicella vaccine virus). Severely immunosuppressed persons should not be given live vaccines for this reason. Persons with isolated B-cell deficiency may receive varicella vaccine. Inactivated vaccines cannot replicate, so they are safe to use in immunosuppressed persons. However, response to the vaccine may be decreased. 19 General Recommendations on Immunization
General Recommendations on Immunization Both dise ses and drugs can cause significant immunosup- presio.Persons with congenita m immuno sed person is in the household.However. MMR.vcella ccin LAlV may be given when an immunosuppressed person lives in the same house Immunosuppression Certain drugs may cause immunosup For instance persons receiving cancer treatment with alkylating agents or d not be given ·Antimetabolites Radiation 二 one Immunosuppression day for 14days or longer. e0emesero 洛m9收day nati ma,are no alt rapidly tapering,and short (less than 14 days)high-dose eoTaeg0ees,teeaeday, chedbletopicalfomulhionsandPhrsiolkgterphccmeat The safety and efficacy of live attenuated vaccines administere conounremtdywihrecobinantkhma ators and immunem nd ane reactivation ent tub culosis 、tong6 ot knoy一 ing tr cine ma required ro develop an immune response to a vaccine.an detailed in the General Recommendations on HIV Infection Persons infected with human immunodeficiency virus are not contraindicated. 20
2 Both diseases and drugs can cause significant immunosuppression. Persons with congenital immunodeficiency, leukemia, lymphoma, or generalized malignancy should not receive live vaccines. OPV should not be given if an immunosuppressed person is in the household. However, MMR, varicella vaccines, and LAIV may be given when an immunosuppressed person lives in the same house. Certain drugs may cause immunosuppression. For instance, persons receiving cancer treatment with alkylating agents or antimetabolites, or radiation therapy should not be given live vaccines. Live vaccines can be given after chemotherapy has been discontinued for at least 3 months. Persons receiving large doses of corticosteroids should not receive live vaccines. For example, this would include persons receiving 20 milligrams or more of prednisone daily or 2 or more milligrams of prednisone per kilogram of body weight per day for 14 days or longer. Aerosolized steroids, such as inhalers for asthma, are not contraindications to vaccination, nor are alternate-day, rapidly tapering, and short (less than 14 days) high-dose schedules, topical formulations, and physiologic replacement schedules. The safety and efficacy of live attenuated vaccines administered concurrently with recombinant human immune mediators and immune modulators is not known. There is evidence that use of therapeutic monoclonal antibodies, especially the anti-tumor necrosis factor agents adalimumab, infliximab, and etanercept, may lead to reactivation of latent tuberculosis infection and tuberculosis disease and predispose to other opportunistic infections. Because the safety of live attenuated vaccines for persons receiving these drugs is not known, it is prudent to avoid administration of live attenuated vaccines for at least a month following treatment with these drugs. Inactivated vaccines are not contraindicated for immunosuppressed persons. However, response to the vaccine may be poor. Because a relatively functional immune system is required to develop an immune response to a vaccine, an immunosuppressed person may not be protected even if the vaccine has been given. Additional recommendations for vaccination of immunosuppressed persons are detailed in the General Recommendations on Immunization. HIV Infection Persons infected with human immunodeficiency virus (HIV) may have no symptoms, or may be severely immunosuppressed. In general, the same vaccination recommendations apply as with other types of immunosuppression. Live-virus vaccines are usually contraindicated, but inactivated vaccines are not contraindicated. 20 General Recommendations on Immunization