Vaccination section -Autoimmune diseases

Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions Recommendations of the Advisory Committee on Immunization Practices (ACIP) part-2
 

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IPV

No serious side effects of currently available IPV have been documented. Since IPV contains trace amounts of streptomycin and neomycin, there is a possibility of hypersensitivity reactions in individuals sensitive to these antibiotics.

MEASLES PREVENTION

The following recommendations concerning adverse events associated with measles vaccination update those applicable sections in "Measles Prevention: Recommendations of the Immunization Practices Advisory Committee" (MMWR 1989; 38{No. S-9}), and they apply regardless of whether the vaccine is administered as a single antigen or as a component of measles-rubella (MR) or measles-mumps-rubella (MMR) vaccine. Information concerning adverse events associated with the mumps component of MMR vaccine is reviewed later in this document (see Mumps Prevention), and information concerning the rubella component is located in the previously published ACIP statement for rubella (18).

Side Effects and Adverse Reactions

More than 240 million doses of measles vaccine were distributed in the United States from 1963 through 1993. The vaccine has an excellent record of safety. From 5% to 15% of vaccinees may develop a temperature of greater than or equal to 103 F ( greater than or equal to 39.4 C) beginning 5-12 days after vaccination and usually lasting several days (19). Most persons with fever are otherwise asymptomatic. Transient rashes have been reported for approximately 5% of vaccinees. Central nervous system (CNS) conditions, including encephalitis and encephalopathy, have been reported with a frequency of less than one per million doses administered. The incidence of encephalitis or encephalopathy after measles vaccination of healthy children is lower than the observed incidence of encephalitis of unknown etiology. This finding suggests that the reported severe neurologic disorders temporally associated with measles vaccination were not caused by the vaccine. These adverse events should be anticipated only in susceptible vaccinees and do not appear to be age-related. After revaccination, most reactions should be expected to occur only among the small proportion of persons who failed to respond to the first dose. Personal and Family History of Convulsions

As with the administration of any agent that can produce fever, some children may have a febrile seizure. Although children with a personal or family history of seizures are at increased risk for developing idiopathic epilepsy, febrile seizures following vaccinations do not in themselves increase the probability of subsequent epilepsy or other neurologic disorders. Most convulsions following measles vaccination are simple febrile seizures, and they affect children without known risk factors.

An increased risk of these convulsions may occur among children with a prior history of convulsions or those with a history of convulsions in first-degree family members (i.e., siblings or parents) (20). Although the precise risk cannot be determined, it appears to be low.

In developing vaccination recommendations for these children, ACIP considered a number of factors, including risks from measles disease, the large proportion (5%-7%) of children with a personal or family history of convulsions, and the fact that convulsions following measles vaccine are uncommon. Studies conducted to date have not established an association between MMR vaccination and the development of a residual seizure disorder (5). ACIP concluded that the benefits of vaccinating these children greatly outweigh the risks. They should be vaccinated just as children without such histories.

Because the period for developing vaccine-induced fever occurs approximately 5-12 days after vaccination, prevention of febrile seizures is difficult. Prophylaxis with antipyretics has been suggested as one alternative, but these agents may not be effective if given after the onset of fever. To be effective, such agents would have to be initiated before the expected onset of fever and continued for 5-7 days. However, parents should be alert to the occurrence of fever after vaccination and should treat their children appropriately.

Children who are being treated with anticonvulsants should continue to take them after measles vaccination. Because protective levels of most currently available anticonvulsant drugs (e.g., phenobarbital) are not achieved for some time after therapy is initiated, prophylactic use of these drugs does not seem feasible.

The parents of children who have either a personal or family history of seizures should be advised of the small increased risk of seizures following measles vaccination. In particular, they should be told in advance what to do in the unlikely event that a seizure occurs. The permanent medical record should document that the small risk of postimmunization seizures and the benefits of vaccination have been discussed.

Subacute Sclerosing Panencephalitis (SSPE)

Measles vaccine significantly reduces the likelihood of developing SSPE, as evidenced by the near elimination of SSPE cases after widespread measles vaccination began. SSPE has been reported rarely in children who do not have a history of natural measles infection but who have received measles vaccine. The available evidence suggests that at least some of these children may have had an unidentified measles infection before vaccination and that the SSPE probably resulted from the natural measles infection. The administration of live measles vaccine does not increase the risk for SSPE, regardless of whether the vaccinee has had measles infection or has previously received live measles vaccine (5,21).

Thrombocytopenia

Surveillance of adverse reactions in the United States and other countries indicates that MMR vaccine can, in rare circumstances, cause clinically apparent thrombocytopenia within the 2 months after vaccination. In prospective studies, the reported incidence of clinically apparent thrombocytopenia after MMR vaccination ranged from one case per 30,000 vaccinated children in Finland (22) and Great Britain (23) to one case per 40,000 in Sweden, with a temporal clustering of cases occurring 2-3 weeks after vaccination (24). With passive surveillance, the reported incidence was approximately one case per 100,000 vaccine doses distributed in Canada and France (25), and approximately one case per 1 million doses distributed in the United States (26). The clinical course of these cases was usually transient and benign, although hemorrhage occurred rarely (26). Furthermore, the risk for thrombocytopenia during rubella or measles infection is much greater than the risk after vaccination. Of 30,000 school-children in one Pennsylvania county who had been infected with rubella during the 1963-64 measles epidemic, 10 children developed thrombocytopenic purpura (incidence: one case per 3,000 children) (27). Based on case reports, the risk for thrombocytopenia may be higher for persons who previously have had idiopathic thrombocytopenic purpura, particularly for those who had thrombocytopenic purpura after an earlier dose of MMR vaccine (5,28,29).

Revaccination Risks

There is no evidence of an increased risk for adverse reactions after administration of live measles vaccine to persons who are already immune to measles as a result of either previous vaccination or natural disease.

Precautions and Contraindications Pregnancy

Live measles vaccine, when given as a component of MR or MMR, should not be given to women known to be pregnant or who are considering becoming pregnant within the next 3 months. Women who are given monovalent measles vaccine should not become pregnant for at least 30 days after vaccination. This precaution is based on the theoretical risk of fetal infection, although no evidence substantiates this theoretical risk. Considering the importance of protecting adolescents and young adults against measles, asking women if they are pregnant, excluding those who are, and explaining the theoretical risks to the others before vaccination are sufficient precautions.

Febrile Illness

The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the cause of the illness and the severity of symptoms. Minor illnesses, such as a mild upper-respiratory infection with or without low-grade fever, are not contraindications for vaccination. For persons whose compliance with medical care cannot be assured, every opportunity should be taken to provide appropriate vaccinations.

Children with moderate or severe febrile illnesses can be vaccinated as soon as they have recovered from the acute phase of the illness. This wait avoids superimposing adverse effects of vaccination on the underlying illness or mistakenly attributing a manifestation of the underlying illness to the vaccine. Performing routine physical examinations or measuring temperatures are not prerequisites for vaccinating infants and children who appear to be in good health. Asking the parent or guardian if the child is ill, postponing vaccination for children with moderate or severe febrile illnesses, and vaccinating those without contraindications are appropriate procedures in childhood immunization programs.

Allergic Reactions

Hypersensitivity reactions rarely occur after the administration of MMR or any of its component vaccines. Most of these reactions are minor and consist of a wheal and flare or urticaria at the injection site. Immediate, anaphylactic reactions to MMR or its component vaccines are extremely rare. Although greater than 70 million doses of MMR vaccine have been distributed in the United States since VAERS was implemented in 1990, only 33 cases of anaphylactic reactions that occurred after MMR vaccination have been reported. Furthermore, only 11 of these cases a) occurred immediately after vaccination and b) occurred in persons who had symptoms consistent with anaphylaxis (CDC, unpublished data).

In the past, persons who had a history of anaphylactic reactions (i.e., hives, swelling of the mouth or throat, difficulty breathing, hypotension, and shock) following egg ingestion were considered to be at increased risk for serious reactions after receipt of measles-containing vaccines, which are produced in chick embryo fibroblasts. Protocols requiring caution were developed for skin testing and vaccinating persons who had had anaphylactic reactions after egg ingestion (30-34). However, the predictive value of such skin testing and the need for special protocols when vaccinating egg-allergic persons with measles-containing vaccines is uncertain. The results of recent studies suggest that anaphylactic reactions to measles-containing vaccines are not associated with hypersensitivity to egg antigens but with some other component of the vaccines. The risk for serious allergic reaction to these vaccines in egg-allergic patients is extremely low, and skin testing is not necessarily predictive of vaccine hypersensitivity (35-37). Therefore, ACIP is re-evaluating whether skin testing and the use of special protocols are routinely necessary when administering MMR or other measles-containing vaccines to persons who have a history of anaphylactic-like reactions after egg ingestion.

MMR and its component vaccines contain hydrolyzed gelatin as a stabilizer. The literature contains a single case report of a person with an anaphylactic sensitivity to gelatin who had an anaphylactic reaction after receipt of the MMR vaccine licensed in the United States (38). Similar cases have occurred in Japan (39). Therefore, ACIP is currently considering recommendations for vaccination of persons who have had an anaphylactic reaction to gelatin or gelatin-containing products. In the meantime, such persons should be vaccinated with MMR and its component vaccines with extreme caution.

MMR vaccine and its component vaccines contain trace amounts of neomycin. Although the amount present is less than that usually used for a skin test to determine hypersensitivity, persons who have experienced anaphylactic reactions to neomycin should not be given these vaccines. Most often, neomycin allergy is manifested by contact dermatitis rather than anaphylaxis. A history of contact dermatitis to neomycin is not a contraindication to receiving measles vaccine. Live measles virus vaccine does not contain penicillin.

Thrombocytopenia

Children who have a history of thrombocytopenic purpura or thrombocytopenia may be at increased risk for developing clinically significant thrombocytopenia after MMR vaccination. The decision to vaccinate should depend on the benefits of immunity to measles, mumps, and rubella and the risks for recurrence or exacerbation of thrombocytopenia after vaccination or during natural infections with measles or rubella. The benefits of immunization are usually greater than the potential risks, and administration of MMR vaccine is justified -- particularly with regard to the even greater risk for thrombocytopenia after measles or rubella disease. However, avoiding a subsequent dose might be prudent if the previous episode of thrombocytopenia occurred in close temporal proximity to (i.e., within 6 weeks after) the previous vaccination. Serologic evidence of measles immunity in such persons may be sought in lieu of MMR vaccination.

Recent Administration of Immune Globulins

Previous recommendations, based on data from persons who received low doses of immune globulin preparations, stated that MMR and its individual component vaccines could be administered as early as 6 weeks to 3 months after administration of immune globulins (40,41). However, recent evidence suggests that high doses of immune globulins can inhibit the immune response to measles vaccine for more than 3 months (42,43). Administration of immune globulins also can inhibit the response to rubella vaccine (42). The effect of immune globulin preparations on the response to mumps vaccine is unknown, but commercial immune globulin preparations contain antibodies to these viruses.

Blood (e.g., whole blood, packed red blood cells, and plasma) and other antibody-containing blood products (e.g., immune globulin; specific immune globulins; and immune globulin, intravenous {IGIV}) can diminish the immune response to MMR or its individual component vaccines. Therefore, after an immune globulin preparation is received, these vaccines should not be administered before the recommended interval (Table_4) and (Table_5). However, the postpartum vaccination of rubella-susceptible women with the rubella or MMR vaccine should not be delayed because anti-Rho(D) IG (human) or any other blood product was received during the last trimester of pregnancy or at delivery. These women should be vaccinated immediately after delivery and, if possible, tested at least 3 months later to ensure immunity to rubella and, if necessary, to measles.

If administration of an immune globulin preparation becomes necessary because of imminent exposure to disease, MMR or its component vaccines can be administered simultaneously with the immune globulin preparation, although vaccine-induced immunity might be compromised. The vaccine should be administered at a site remote from that chosen for the immune globulin inoculation. Unless serologic testing indicates that specific antibodies have been produced, vaccination should be repeated after the recommended interval (Table_4) and (Table_5).

If administration of an immune globulin preparation becomes necessary after MMR or its individual component vaccines have been administered, interference can occur. Usually, vaccine virus replication and stimulation of immunity will occur 1-2 weeks after vaccination. Thus, if the interval between administration of any of these vaccines and subsequent administration of an immune globulin preparation is less than 14 days, vaccination should be repeated after the recommended interval (Table_4) and (Table_5), unless serologic testing indicates that antibodies were produced.

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