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Contraindications and Precautions to Vaccination. Andrew Kroger, MD, MPH National Center for Immunization and Respiratory Diseases. North Carolina Statewide Immunization Conference August 11, 2011. Disclosures.
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Contraindications and Precautions to Vaccination Andrew Kroger, MD, MPH National Center for Immunization and Respiratory Diseases North Carolina Statewide Immunization Conference August 11, 2011
Disclosures Andrew Kroger is a federal government employee with no financial interest or conflict with the manufacturer of any product named in this presentation Andrew Kroger will not discuss a vaccine not currently licensed by the FDA
Contraindication • A condition in a recipient which greatly increases the chance of a serious adverse event
Precaution • A condition in a recipient which may increase the chance or severity of an adverse event, orMay compromise the ability of the vaccine to produce immunity
Contraindications and Precautions • Severe allergic reaction to a prior dose of vaccine or to a vaccine component • Encephalopathy not due to another identifiable cause occurring within 7 days of pertussis vaccination (for pertussis vaccines) • Severe Combined Immunodeficiency Disease (for rotavirus vaccine) Permanent contraindications to vaccination:
Contraindications and Precautions ConditionAllergy to Component Encephalopathy Pregnancy Immunosuppression Moderate-severe illness Recent blood product Live C --- C C P P** Inactivated C C V* V P V C=contraindication P=precaution V=vaccinate if indicated *except HPV and Tdap. **MMR and varicella-containing (except zoster vaccine)
Vaccination During Pregnancy • Disease risk to a developing fetus from vaccination of the mother during pregnancy is primarily theoretical • Only smallpox (vaccinia) vaccine has ever been shown to injure a fetus • The benefits of vaccinating usually outweigh potential risks
Vaccination During Pregnancy • Inactivated vaccines • routine (influenza – any trimester; Tdap – 20 weeks or later NEW) • vaccinate if indicated (Hep B) • vaccinate if increased risk (all others, except HPV) • Live vaccines – do not administer • exception is yellow fever vaccine
Yellow Fever Vaccination in Pregnancy • No evidence of harm to fetus from vaccination of mother, limited theoretical risk • Pregnant women who must travel to areas where the risk for yellow fever is high should receive the vaccine
Vaccination of Immunosuppressed Persons • Live vaccines should not be administered to severely immunosuppressed persons • Persons with isolated B-cell deficiency may receive varicella vaccine • Inactivated vaccines are safe to use in immunosuppressed persons but the response to the vaccine may be decreased
Vaccination of Immunocompromised Persons with Inactivated vaccines • It is preferable to vaccinate* an immunocompromised person and obtain a less-than-optimal response than to withhold the vaccine and obtain NO response *inactivated vaccines only
Immunosuppression • Disease • Congenital immunodeficiency • Leukemia or lymphoma • Generalized malignancy • Chemotherapy • Alkylating agents • Antimetabolites • Radiation
Immunosuppressive Drugs • Immune mediators • Immune modulators • Iso-antibodies
Corticosteroids and Immunosuppression • The amount or duration of corticosteroid therapy needed to increase adverse event risk is not well defined • Dose generally believed to be a concern: • 20 mg or more/day of prednisone for 2 weeks or longer • 2 mg/kg per day or more of prednisone for 2 weeks or longer • NOT aerosols, topical, alternate day, short courses (less than 2 weeks), physiologic replacement schedules • Delay live vaccines for at least 1 month after discontinuation of high dose therapy
Vaccination of Immunocompromised Persons • Susceptible immunocompromised persons are at increased risk of adverse events following live vaccines • Live vaccines may be administered at least 3 months following termination of chemotherapy (at least 1 month after high-dose steroids use of 2 weeks or more) • LAIV, MMR, varicella, and rotavirus vaccines may be administered to susceptible household and other close contacts
Live Attenuated Vaccines for Persons with HIV/AIDS* Vaccine Varicella Zoster MMR MMRV LAIV Rotavirus Yellow Fever Asymptomatic Yes No Yes No No Consider Consider Symptomatic* No No No No No Consider No Yes=vaccinate No=do not vaccinate *See specific ACIP recommendations for details.
Household Contacts of HIV-infected Persons • Susceptible household contacts of persons with HIV infection • SHOULD receive MMR and varicella vaccines • MAY receive LAIV, zoster and rotavirus vaccines if eligible.
New Topics of Interest • Intussusception • Severe allergic reaction or hives following egg ingestion • Past adverse reactions to vaccines • Arthus reaction • Guillain-Barré Syndrome
Rotavirus Vaccine Data are mixed as to risk of intussusception following first dose of rotavirus vaccine • Post-licensure trials • Cohort study – Mexico, Brazil • Case-control study • Safety surveillance - Australia
Intussusception and Rotavirus Vaccine • A history of intussusception is considered a PRECAUTION for rotavirus vaccine
Allergy Following Egg Ingestion • Evidence that persons with mild, moderate, or severe allergy to eggs can tolerate TIV • Quantity of ovalbumin (egg protein) in dose of TIV less than 0.7 mcg • Severe egg allergy now a precaution, not a contraindication for TIV
Severe Allergy to Eggs • Respiratory (e.g. wheezing) • Cardiovascular • Gastrointestinal • History of reaction requiring epinephrine or emergency medical treatment • Referral to a provider skilled in management and treatment of anaphylaxis
Arthus Reactions • Local reactions caused by circulating antibody/antigen complexes • Frequent subsized dosing of diphtheria-toxoid or tetanus-toxoid
Arthus Reaction • If an Arthus reaction occurs following a dose of tetanus-toxoid OR diphtheria-toxoid containing vaccine, wait ten years from the last tetanus-toxoid containing vaccine to give the next dose
Guillain-Barré Syndrome • Peripheral neuropathy • Ascending • Loss of reflexes • Can require intensive care • Multifactorial
Guillain-Barré Syndrome • Can occur after vaccination • NOT a contraindication • Precaution • influenza vaccine (if occurs within 6 weeks of a previous dose of any brand/type) • Tetanus-toxoid containing vaccine (if occurs within 6 weeks of a previous dose of any brand/type) • Neither a contraindication NOR a precaution for meningococcal conjugate vaccine (MCV4)
Guillain-Barré Syndrome • High background rate 1/100,000 population • Most common cause is Campylobacter infection • Attributable risk due to influenza vaccine 1/1,000,000 vaccinations
GBS Risk / Benefit Guillain-Barré syndrome Influenza disease hospitalization in high-risk Population based cardiopulmonary death rate 5/1,000,000 in persons YOUNGER than 50 years Five times higher Hospitalization rate In non-hisk risk younger than 45 years 5000 per million (five thousand times higher) Child ED adminisssion rates 16,000 per million • Attibutable risk • 1/1,000,000 vaccinations
THE Benefit of giving influenza vaccine to someone with a history of guillain-barré syndrome that is high-risk for influenza disease outweighs the risk of another episode of guillain-barré
Invalid Contraindication to Vaccination • Mild illness • Preterm birth • Mild local reactions • Disease exposure or convalescence • Pregnancy in the household • Breastfeeding • Allergies to products not in vaccines • Need for TB skin testing • Need for multiple vaccines • Lack of a previous physical exam
Invalid ContraindicationsMild Illness • Vaccinate with: • low grade fever • upper respiratory infection • otitis media • mild diarrhea
Invalid ContraindicationsPreterm Birth • Generally, infants and children should be vaccinated according to chronologic age (not gestational age) • As with all rules, there are exceptions
Preterm Birth • Hepatitis birth dose • if the mother is documented to be hepatitis B surface antigen negative • then first dose may be delayed until chronologic age one month or at time of hospital discharge
Preterm Birth • If the mother is HBsAg positive or unknown • give birth dose of HepB vaccine • give HBIG unless mom is found to be surface antigen negative within 12 hours • do NOT count birth dose – three additional doses
Screening • Specific questions intended to identify contraindications or precautions to vaccination • Screening must occur at every immunization encounter (not just before the first dose) • Use of a standardized form will facilitate effective screening
Screening Questions • Is the child (or are you) sick today? • Does the child have an allergy to any medications, food, or any vaccine? • Has the child had a serious reaction to a vaccine in the past?
Screening Questions • Has the child had a seizure, brain or nerve problem? • Has the child had a health problem with asthma, lung disease, heart disease, kidney disease, metabolic disease, such as diabetes, or a blood disorder?
Screening Questions • Does the child have cancer, leukemia, AIDS, or any other immune system problem? • Has the child taken cortisone, prednisone, other steroids, or anticancer drugs, or had x-ray treatments in the past 3 months?
Screening Questions • Has the child received a transfusion of blood or blood products, or been given a medicine called immune (gamma) globulin in the past year? • Is the child/teen pregnant or is there a chance she could become pregnant during the next month? • Has the child received vaccinations in the past 4 weeks?
Benefit and Risk Communication • Opportunities for questions should be provided before each vaccination • Vaccine Information Statements (VISs) • must be provided before each dose of vaccine • public and private providers • available in multiple languages
Thank You Hotline: 800.CDC.INFO Email: nipinfo@cdc.gov Website: www.cdc.gov/vaccines