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Contraindications and Precautions

General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP)

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Updates

Major changes to the best practice guidance in this section include 1) enhancement of the definition of a “precaution” to include any condition that might confuse diagnostic accuracy and 2) recommendation to vaccinate during a hospitalization if a patient is not acutely moderately or severely ill.

 

General Principles

Contraindications (conditions in a recipient that increases the risk for a serious adverse reaction) and precautions to vaccination are conditions under which vaccines should not be administered. Because the majority of contraindications and precautions are temporary, vaccinations often can be administered later when the condition leading to a contraindication or precaution no longer exists. A vaccine should not be administered when a contraindication is present; for example, MMR vaccine should not be administered to severely immunocompromised persons (1). However, certain conditions are commonly misperceived as contraindications (i.e., are not valid reasons to defer vaccination).

National standards for pediatric vaccination practices have been established and include descriptions of valid contraindications and precautions to vaccination (2). Persons who administer vaccines should screen patients for contraindications and precautions to the vaccine before each dose of vaccine is administered (Table 4-1). Screening is facilitated by consistent use of screening questionnaires, which are available from certain state vaccination programs and other sources (e.g., the Immunization Action Coalition).

Severely immunocompromised persons generally should not receive live vaccines (3). Because of the theoretical risk to the fetus, women known to be pregnant generally should not receive live, attenuated virus vaccines (4). Persons who experienced encephalopathy within 7 days after administration of a previous dose of pertussis-containing vaccine not attributable to another identifiable cause should not receive additional doses of a vaccine that contains pertussis (4, 5). Severe Combined Immunodeficiency (SCID) disease and a history of intussusception are both contraindications to the receipt of rotavirus vaccines (6).

A precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the ability of the vaccine to produce immunity (e.g., administering measles vaccine to a person with passive immunity to measles from a blood transfusion administered up to 7 months prior) (7). A person might experience a more severe reaction to the vaccine than would have otherwise been expected; however, the risk for this happening is less than the risk expected with a contraindication. In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction.

The presence of a moderate or severe acute illness with or without a fever is a precaution to administration of all vaccines (Table 4-1). The decision to administer or delay vaccination because of a current or recent acute illness depends on the severity of symptoms and etiology of the condition. The safety and efficacy of vaccinating persons who have mild illnesses have been documented (8-11). Vaccination should be deferred for persons with a moderate or severe acute illness. This precaution avoids causing diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination or superimposing adverse effects of the vaccine on the underlying illness. After they are screened for contraindications, persons with moderate or severe acute illness should be vaccinated as soon as the acute illness has improved. Studies indicate that failure to vaccinate children with minor illnesses can impede vaccination efforts (12–14). Among persons whose compliance with medical care cannot be ensured, use of every opportunity to administer appropriate vaccines is critical.

Hospitalization should be used as an opportunity to provide recommended vaccinations. Health-care facilities are held to standards of offering influenza vaccine for hospitalized patients, so providers are incentivized to vaccinate these patients at some point during hospitalization (15). Likewise, patients admitted for elective procedures will not be acutely ill during all times during their hospitalization. Most studies that have explored the effect of surgery or anesthesia on the immune system were observational, included only infants and children, and were small and indirect, in that they did not look at the immune effect on the response to vaccination specifically (16-35). They do not provide convincing evidence that recent anesthesia or surgery significantly affect response to vaccines. Current, recent, or upcoming anesthesia/surgery/hospitalization is not a contraindication to vaccination (16-35). Efforts should be made to ensure vaccine administration during the hospitalization or at discharge. For patients who are deemed moderately or severely ill throughout the hospitalization, vaccination should occur at the earliest opportunity (i.e., during immediate post-hospitalization follow-up care, including home or office visits) when patients’ clinical symptoms have improved.

A personal or family history of seizures is a precaution for MMRV vaccination; this is because a recent study found an increased risk for febrile seizures in children 12-23 months who receive MMRV compared with MMR and varicella vaccine (36).

Clinicians or other health-care providers might misperceive certain conditions or circumstances as valid contraindications or precautions to vaccination when they actually do not preclude vaccination (2) (Table 4-2). These misperceptions result in missed opportunities to administer recommended vaccines (37).

Routine physical examinations and procedures (e.g., measuring temperatures) are not prerequisites for vaccinating persons who appear to be healthy. The provider should ask the parent or guardian if the child is ill. If the child has a moderate or severe illness, the vaccination should be postponed.

TABLE 4-1. Contraindications and precautions(a) to commonly used vaccines

Vaccine Citation Contraindications Precautions
DT, Td (4) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component GBS <6 weeks after previous dose of tetanus-toxoid–containing vaccine

History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid—containing or tetanus-toxoid–containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid-containing vaccine

Moderate or severe acute illness with or without fever

DTaP (38) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

Encephalopathy (e.g., coma, decreased level of consciousness,  prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP or DTaP

Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy; defer DTaP until neurologic status clarified and stabilized

Temperature of ≥105°F (≥40.5°C) within 48 hours after vaccination with a previous dose of DTP or DTaP

Collapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hours after receiving a previous dose of DTP/DTaP

Seizure ≤3 days after receiving a previous dose of DTP/DTaP

Persistent, inconsolable crying lasting ≥3 hours within 48 hours after receiving a previous dose of DTP/DTaP

GBS <6 weeks after previous dose of tetanus-toxoid–containing vaccine

History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid–containing or tetanus-toxoid–containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid–containing vaccine

Moderate or severe acute illness with or without fever

Hepatitis A (39) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Moderate or severe acute illness with or without fever
Hepatitis B (40) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

Hypersensitivity to yeast

Moderate or severe acute illness with or without fever
Hib (41) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

Age <6 weeks

Moderate or severe acute illness with or without fever
HPV (42) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Pregnancy

Moderate or severe acute illness with or without fever

IIV (43) Severe allergic reaction (e.g., anaphylaxis) after previous dose of influenza vaccine or to vaccine component. GBS <6 weeks after a previous dose of influenza vaccine

Moderate or severe acute illness with or without fever

Egg allergy other than hives, e.g., angioedema, respiratory distress, lightheadedness, recurrent emesis; or required epinephrine or another emergency medical intervention (IIV may be administered in an inpatient or outpatient medical setting and under the supervision of a health care provider who is able to recognize and manage severe allergic conditions).

IPV (44) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Pregnancy

Moderate or severe acute illness with or without fever

LAIV(b) (43) Severe allergic reaction (e.g., anaphylaxis) after a vaccine component, including egg protein

Concomitant use of aspirin or aspirin-containing medication in children and adolescents

LAIV4 should not be administered to persons who have taken influenza antiviral medications within the previous 48 hours

GBS <6 weeks after a previous dose of influenza vaccine

Asthma in persons aged 5 years old or older

Medical conditions which might predispose to higher risk of complications attributable to influenza(c)

Moderate of severe acute illness with or without fever

MenACWY (45) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Moderate or severe acute illness with or without fever
MenB (46, 47) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Moderate or severe acute illness with or without fever
MMR(d),(e) (1) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

Pregnancy

Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy(f) or patients with HIV infection who are severely immunocompromised)

Family history of altered immunocompetence

Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product)

History of thrombocytopenia or thrombocytopenic purpura

Need for tuberculin skin testing or interferon-gamma release assay (IGRA) testing(g)

Moderate or severe acute illness with or without fever

MPSV4 (48) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Moderate or severe acute illness with or without fever
PCV13 (49) Severe allergic reaction (e.g., anaphylaxis) after a previous dose of PCV13 or any diphtheria-toxoid–containing vaccine or to a component of a vaccine (PCV13 or any diphtheria-toxoid–containing vaccine) Moderate or severe acute illness with or without fever
PPSV23 (50) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Moderate or severe acute illness with or without fever
RIV (43) Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine GBS <6 weeks after a previous dose of influenza vaccine

Moderate or severe acute illness with or without fever

Rotavirus (6) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

SCID

History of intussusception

Altered immunocompetence other than SCID

Chronic gastrointestinal disease(h)

Spina bifida or bladder exstrophy(h)

Moderate or severe acute illness with or without fever

Tdap (51) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

Encephalopathy (e.g., coma, decreased level of consciousness,  prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP, DTaP, or Tdap

GBS <6 weeks after a previous dose of tetanus-toxoid–containing vaccine

Progressive or unstable neurological disorder, uncontrolled seizures, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized

History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid—containing or tetanus-toxoid–containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid–containing vaccine

Moderate or severe acute illness with or without fever

Varicella(d),(e) (52) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency,  long-term immunosuppressive therapy(f) or patients with HIV infection who are severely immunocompromised)(e)

Pregnancy

Family history of altered immunocompetence

Recent (≤11 months) receipt of antibody-containing blood product (specific interval depends on product)

Moderate or severe acute illness with or without fever

Receipt of specific antiviral drugs (acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination (avoid use of these antiviral drugs for 14 days after vaccination)

Zoster (53) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component

Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency,  long-term immunosuppressive therapy(f) or patients with HIV infection who are severely immunocompromised)(e)

Pregnancy

Moderate or severe acute illness with or without fever

Receipt of specific antiviral drugs (acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination (avoid use of these antiviral drugs for 14 days after vaccination)

Abbreviations: DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; DTP = diphtheria toxoid, tetanus toxoid, and pertussis; GBS = Guillain-Barré syndrome; Hib = Haemophilus influenzae type b; HIV = human immunodeficiency virus; HPV = human papillomavirus; IIV = inactivated influenza vaccine; IPV = inactivated poliovirus; LAIV = live, attenuated influenza vaccine; MenACWY = quadrivalent meningococcal conjugate vaccine; MMR = measles, mumps, and rubella; MPSV4 = quadrivalent meningococcal polysaccharide vaccine; PCV13 = pneumococcal conjugate vaccine; PPSV23= pneumococcal polysaccharide vaccine; SCID = severe combined immunodeficiency; RIV=recombinant influenza vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.

(a) Events or conditions listed as precautions should be reviewed carefully. Benefits of and risks for administering a specific vaccine to a person under these circumstances should be considered. If the risk from the vaccine is believed to outweigh the benefit, the vaccine should not be administered. If the benefit of vaccination is believed to outweigh the risk, the vaccine should be administered. Whether and when to administer DTaP to children with proven or suspected underlying neurologic disorders should be decided on a case-by-case basis.

(b) In addition, ACIP recommends LAIV not be used for pregnant women, immunosuppressed persons, persons with egg allergy, and children aged 2-4 years who have asthma or who have had a wheezing episode noted in the medical record within the past 12 months, or for whom parents report that a health-care provider stated that they had wheezing or asthma within the last 12 months. LAIV should not be administered to persons who have taken influenza antiviral medications within the previous 48 hours. Persons who care for severely immunosuppressed persons who require a protective environment should not receive LAIV, or should avoid contact with such persons for 7 days after receipt.

(c)Source: (52).

(d) HIV-infected children may receive varicella vaccine if CD4+ T-lymphocyte count is ≥15% and should receive MMR vaccine if they are aged ≥12 months and do not have evidence of current severe immunosuppression (i.e., individuals aged ≤5 years must have CD4+T lymphocyte [CD4] percentages ≥15% for ≥6 months; and individuals aged >5 years must have CD4+percentages ≥15% and CD4+≥200 lymphocytes/mm3 for ≥6 months) or other current evidence of measles, rubella, and mumps immunity. In cases when only CD4+cell counts or only CD4+percentages are available for those older than age 5 years, the assessment of severe immunosuppression can be based on the CD4+values (count or percentage) that are available. In cases when CD4+percentages are not available for those aged ≤5 years, the assessment of severe immunosuppression can be based on age-specific CD4+counts at the time CD4+counts were measured; i.e., absence of severe immunosuppression is defined as ≥6 months above age-specific CD4+count criteria: CD4+count >750 lymphocytes/mm3 while aged ≤12 months and CD4+count ≥500 lymphocytes/mm3 while aged 1 through 5 years. Sources: (1, 50).

(e) MMR and varicella-containing vaccines can be administered on the same day. If not administered on the same day, these vaccines should be separated by at least 28 days.

(f) A substantially immunosuppressive steroid dose is considered to be ≥2 weeks of daily receipt of 20 mg or 2 mg/kg body weight of prednisone or equivalent.

(g) If active tuberculosis is suspected, MMR should be delayed. Measles vaccination might suppress tuberculin reactivity temporarily. Measles-containing vaccine can be administered on the same day as tuberculin skin or IGRA testing. If testing cannot be performed until after the day of MMR vaccination, the test should be postponed for ≥4 weeks after the vaccination. If an urgent need exists to skin test or IGRA, do so with the understanding that reactivity might be reduced by the vaccine.

(h) For details, see (55).

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TABLE 4-2. Conditions incorrectly perceived as contraindications to vaccination (i.e., vaccines may be given under these conditions)

Vaccine Conditions commonly misperceived as contraindications
General for all vaccines, including DTaP, pediatric DT, adult Td, adolescent-adult Tdap, IPV, MMR, Hib, hepatitis A, hepatitis B, varicella, rotavirus, PCV13, IIV, LAIV, PPSV23, MenACWY, MPSV4, HPV, and herpes zoster Mild acute illness with or without fever
Mild to moderate local reaction (i.e., swelling, redness, soreness); low-grade or moderate fever after previous dose
Lack of previous physical examination in well-appearing person
Current antimicrobial therapy(a)
Convalescent phase of illness
Preterm birth (hepatitis B vaccine is an exception in certain circumstances)(b)
Recent exposure to an infectious disease
History of penicillin allergy, other nonvaccine allergies, relatives with allergies, or receiving allergen extract immunotherapy
History of GBS(c)
DTaP Fever of <105°F (<40.5°C), fussiness or mild drowsiness after a previous dose of DTP/DTaP
Family history of seizures
Family history of sudden infant death syndrome
Family history of an adverse event after DTP or DTaP administration
Stable neurologic conditions (e.g., cerebral palsy, well-controlled seizures, or developmental delay)
Hepatitis B Pregnancy
Autoimmune disease (e.g., systemic lupus erythematosus or rheumatoid arthritis)
HPV Immunosuppression
Previous equivocal or abnormal Papanicolaou test
Known HPV infection
Breastfeeding
History of genital warts
IIV Nonsevere (e.g., contact) allergy to latex, thimerosal, or egg
Concurrent administration of Coumadin (generic: warfarin) or aminophylline
IPV Previous receipt of ≥1 dose of oral polio vaccine
LAIV Health-care providers that see patients with chronic diseases or altered immunocompetence (an exception is providers for severely immunocompromised patients requiring care in a protected environment)
Breastfeeding
Contacts of persons with chronic disease or altered immunocompetence (an exception is contacts of severely immunocompromised patients requiring care in a protected environment)
MMR(d),(e) Positive tuberculin skin test
Simultaneous tuberculin skin or interferon-gamma release assay (IGRA) testing(f)
Breastfeeding
Pregnancy of recipient’s mother or other close or household contact
Recipient is female of child-bearing age
Immunodeficient family member or household contact
Asymptomatic or mildly symptomatic HIV infection
Allergy to eggs
PPSV23 History of invasive pneumococcal disease or pneumonia
Rotavirus Prematurity
Immunosuppressed household contacts
Pregnant household contacts
Tdap History of fever of ≥105°F (≥40.5°C) for <48 hours after vaccination with a previous dose of DTP or DTaP
History of collapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hours after receiving a previous dose of DTP/DTaP
History of seizure <3 days after receiving a previous dose of DTP/DTaP
History of persistent, inconsolable crying lasting >3 hours within 48 hours after receiving a previous dose of DTP/DTaP
History of extensive limb swelling after DTP/DTaP/Td that is not an Arthus-type reaction
History of stable neurologic disorder
History of brachial neuritis
Latex allergy that is not anaphylactic
Breastfeeding
Immunosuppression
Varicella Pregnancy of recipient’s mother or other close or household contact
Immunodeficient family member or household contact(g)
Asymptomatic or mildly symptomatic HIV infection
Humoral immunodeficiency (e.g., agammaglobulinemia)
Zoster Therapy with low-dose methotrexate (≤0.4 mg/kg/week), azathioprine (≤3.0 mg/kg/day), or 6-mercaptopurine (≤1.5 mg/kg/day) for treatment of rheumatoid arthritis, psoriasis, polymyositis, sarcoidosis, inflammatory bowel disease, or other conditions
Health-care providers of patients with chronic diseases or altered immunocompetence
Contacts of patients with chronic diseases or altered immunocompetence
Unknown or uncertain history of varicella in a U.S.-born person

Abbreviations: DT = diphtheria and tetanus toxoids; DTP = diphtheria toxoid, tetanus toxoid, and pertussis; DTaP = diphtheria and tetanus toxoids and acellular pertussis; GBS = Guillain-Barré syndrome; HBsAg = hepatitis B surface antigen; Hib = Haemophilus influenzae type b; HIV = human immunodeficiency virus; HPV = human papillomavirus; IIV = inactivated influenza vaccine; IPV = inactivated poliovirus; LAIV = live, attenuated influenza vaccine; MenACWY = quadrivalent meningococcal conjugate vaccine; MMR = measles, mumps, and rubella; MPSV4 = quadrivalent meningococcal polysaccharide vaccine; PCV = pneumococcal conjugate vaccine; PPSV23= pneumococcal polysaccharide vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.

(a) Antibacterial drugs might interfere with Ty21a oral typhoid vaccine, and certain antiviral drugs might interfere with varicella-containing vaccines and LAIV4.

(b) Hepatitis B vaccination should be deferred for infants weighing <2,000 g if the mother is documented to be HBsAg negative. Vaccination should commence at chronological age 1 month or at hospital discharge. For infants born to HBsAg-positive women, hepatitis B immune globulin and hepatitis B vaccine should be administered within 12 hours after birth, regardless of weight.

(c) An exception is Guillain-Barré syndrome within 6 weeks of a dose of influenza vaccine or tetanus-toxoid–containing vaccine, which are precautions for influenza vaccines and tetanus-toxoid containing vaccines, respectively.

(d) MMR and varicella vaccines can be administered on the same day. If not administered on the same day, these vaccines should be separated by at least 28 days.

(e) HIV-infected children should receive immune globulin after exposure to measles. HIV-infected children can receive varicella and measles vaccine if CD4+ T-lymphocyte count is >15%. (54).

(f) Measles vaccination might suppress tuberculin reactivity temporarily. Measles-containing vaccine can be administered on the same day as tuberculin skin or IGRA testing. If testing cannot be performed until after the day of MMR vaccination, the test should be postponed for at least 4 weeks after the vaccination. If an urgent need exists to skin test or IGRA, do so with the understanding that reactivity might be reduced by the vaccine.

(g) If a vaccinee experiences a presumed vaccine-related rash 7-25 days after vaccination, the person should avoid direct contact with immunocompromised persons for the duration of the rash.

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