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General Principles for Immunizations. Federal Requirements for Vaccinators. Vaccine Information Statement (VIS) Give a current, take-home copy of the relevant VIS to the parent, legal representative, or adult recipient before each dose of each vaccine Use the VIS published by the CDC

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federal requirements for vaccinators
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Federal Requirements for Vaccinators
  • Vaccine Information Statement (VIS)
    • Give a current, take-home copy of the relevant VIS to the parent, legal representative, or adult recipient before each dose of each vaccine
    • Use the VIS published by the CDC
    • Mandatory for vaccines covered under the VICP
    • Mandatory for vaccines purchased under federal contract
    • Encouraged for all other vaccines
federal requirements for vaccinators1
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Federal Requirements for Vaccinators
  • Vaccine Information Statement (VIS)
    • Provide VIS for each component of combination vaccines if there is no VIS for the combination
    • Use visual or oral supplements for illiterate or blind patients
    • Translations are available
federal requirements for vaccinators2
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Federal Requirements for Vaccinators
  • Permanent Medical Record or Office Log
    • Name of the VIS, publication date, and date it was given to the recipient
      • Patient signature is not required
      • VIS should not be construed as informed consent, which may be required in some states
    • Name and title of individual who administered the vaccine
    • Date of administration
    • Manufacturer
    • Lot number
    • Address where the permanent record is kept
federal requirements for vaccinators3
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Federal Requirements for Vaccinators
  • Report to VAERS
    • Any event listed by the manufacturer as a contraindication to subsequent doses of the vaccine
    • Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination
  • Adhere to the Occupational Safety and Health Administration Bloodborne Pathogens Standard
rules by which to vaccinate 1
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #1
  • Any vaccines can be given at the same time (using separate sites)
  • Exception: VAR and smallpox vaccine
  • VAR PI warns against concomitant administration with PPSV23 (impaired response to VAR)

VAR: varicella

rules by which to vaccinate 2
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #2
  • Live vaccines not given at the same time should be separated by at least 4 weeks
  • Exceptions
    • YFV may be given at any time after single-antigen measles vaccine
    • Live oral vaccines (RV and Ty21a) may be given at any time in relation to any other live vaccines
    • LAIV is not an exception

YFV: yellow fever vaccine; RV: rotavirus;

Ty21a: typhoid 21a; LAIV: live-attenuated influenza vaccine

rules by which to vaccinate 3
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #3
  • Different inactivated vaccines may be given at any time with respect to each other
  • Exception: The AAP recommends a minimum interval of 1 month between Tdap and MCV4-D (formulation with diphtheria toxoid conjugate, Menactra) if not given on the same day
    • Concern that too many doses of diphtheria toxoid in sequence can cause increased reactogenicity
rules by which to vaccinate 4
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #4
  • There are minimum acceptable intervals between doses of the same vaccine
  • Exceptions
    • The 4-day grace period (not applicable to RAB)
    • Early, accelerated, or compressed schedules in certain situations
  • Caveat
    • A minimum interval is a minimum interval except when it’s not
    • DTaP doses 3 and 4: 6 mo, but 4 is OK
    • VAR doses 1 and 2: 3 mo, but 28 days is OK

RAB: rabies vaccine

rules by which to vaccinate 5
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #5
  • There are minimum ages for administration of all vaccines
  • Exceptions
    • HepB
    • BCG
    • Rabies vaccine
rules by which to vaccinate 6
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #6
  • Partial or fractional doses of a vaccine should never be used
  • Exception: None
rules by which to vaccinate 7
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #7
  • A multidose vaccine series should not be restarted if the recommended dosing interval is exceeded
  • Exception: Oral typhoid Ty21a
rules by which to vaccinate 8
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #8
  • Similar vaccines made by different manufacturers are interchangeable
  • Exception
    • Preference for using the same brand of DTaP, HPV, and RV for the entire series
    • Vaccination should not be deferred if same brand is not available
rules by which to vaccinate 9
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #9
  • There is no harm in vaccinating a person who has already had the disease or the vaccine
  • In fact, there is reason to vaccinate when disease can be caused by multiple serotypes
  • Exceptions
    • Too many doses of PPSV23 or tetanus or diphtheria toxoid-containing vaccines can cause increased reactogenicity
    • Increased reactogenicity if anthrax vaccine given to person who has had anthrax
rules by which to vaccinate 10
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Rules by Which to Vaccinate: #10
  • Live vaccines should be deferred after receipt of antibody-containing blood products
  • Exceptions
    • LAIV, Ty21a, RV, YFV, ZOS
    • MMR and VAR should not be deferred in postpartum women who received antibody-containing blood products during pregnancy, including anti-Rho(D) globulin
other vaccination pearls
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Other Vaccination Pearls
  • Indications for serology
    • Prevaccination
      • Adults without personal history of chickenpox
      • Internationally adopted children (consider)
    • Postvaccination
      • HepB: high-risk health care workers and dialysis patients
      • RAB: pre-exposure prophylaxis for laboratory workers
      • Some cases of invalid dosing
other vaccination pearls1
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Other Vaccination Pearls
  • Physical examination not required for vaccination
  • Gloves not routinely needed
  • Not necessary to change needles after withdrawing vaccine from vial
  • Rubber stopper should be swiped with alcohol
  • Aspirating back on the syringe not necessary
  • Injections in the same area should be separated by ≥ 1 inch
  • Syringes should not be prefilled by the end user (exception: mass influenza immunization campaigns where only 1 vaccine type is being used)
contraindications
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Contraindications
  • Contraindications increase likelihood of a serious adverse event
    • When present, vaccine should not be given
  • Permanent contraindications for all vaccines: severe allergy to vaccine or component
precautions
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Precautions
  • Might increase risk of a serious adverse event
  • Could compromise immunogenicity
  • Could be mistaken for a vaccine reaction
  • Default position: defer vaccination
    • Risk of deferral: susceptibility to disease
    • Risk of vaccination: largely theoretical
  • Considerations: epidemiology of disease, patient’s circumstances, missed opportunities
notable contraindications
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Notable Contraindications
  • DTaP
    • Encephalopathy within 7 days of pertussis-containing vaccine
    • Progressive neurological disorder (until stabilized)
  • Allergic to components
    • Baker’s yeast: HepB, HPV
    • Rodent or neural proteins: JEV (JE-VAX)
    • Eggs: LAIV, IIV, YFV
    • Gelatin or neomycin: MMR, VAR
notable contraindications1
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Notable Contraindications
  • Pregnancy: LAIV, MMR, smallpox, VAR, ZOS
  • Immune impairment
    • Any: smallpox, Ty21a, YFV
    • Severe: LAIV, MMR, VAR, ZOS
  • Aspirin or salicylate therapy: LAIV
  • Untreated active TB: MMR, VAR, ZOS
vaccine screening questions
IAC. http://www.immunize.org/catg.d/p4060.pdf. Accessed Nov 2010.Vaccine Screening Questions
  • Is the child sick today?
  • Does the patient have allergies to medicines, food, a vaccine component, or latex?
  • Has the patient had serious reactions to previous vaccinations?
  • Has the child had a health problem with lung, heart, kidney or metabolic disease (eg, diabetes), asthma, or a blood disorder? Is he/she on long-term aspirin therapy?
  • If the child is between 2 and 4 years, has a health care provider told you that the child had wheezing or asthma in the past 12 months?
vaccine screening questions1
Vaccine Screening Questions
  • Has the child, a sibling, or parent had a seizure; has the child had brain or other nervous system problems?
  • Does the child have cancer, leukemia, AIDS, or another immune system problem?
  • Has the child taken cortisone, prednisone, other steroids, anticancer drugs, or had radiation treatments in the past 3 months?
  • Has the child received a blood or blood product transfusion, been given immune globulin or an antiviral drug in the last year?
  • Is the child/teen pregnant or is there a chance of becoming pregnant in the next month?
  • Has the child received vaccinations in the past 4 weeks?

IAC. http://www.immunize.org/catg.d/p4060.pdf. Accessed Nov 2010.

erroneous contraindications
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Erroneous Contraindications
  • Mild acute illness with or without fever
  • Mild respiratory illness (including otitis media)
  • Mild gastroenteritis
  • Antibiotic or antiviral therapy
  • Low-grade fever, redness, pain, swelling after pervious dose
  • Prematurity (delay HepB in infants < 2000 gm whose mothers are HBsAg-negative)
  • Pregnant, unimmunized, or immunosuppressed household contact (except pre-event smallpox)
erroneous contraindications1
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010.Erroneous Contraindications
  • Breastfeeding (except pre-event smallpox)
  • Convalescent phase of illness
  • Exposure to an infectious disease
  • Positive tuberculin skin test without active disease
  • Simultaneous tuberculin skin test
  • Allergy to penicillin, duck meat or feathers, or environmental allergens
  • Fainting after previous dose
  • Seizures, SIDS, allergies, vaccine reactions in family members
erroneous contraindications2
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Erroneous Contraindications
  • Malnutrition
  • Lack of a previous physical exam in a well-appearing individual
  • Stable neurological condition (eg, CP, seizures, developmental delay)
  • Allergy shots
  • Extensive limb swelling after DTP, DTaP, or Td that is not an Arthus-type reaction
  • Brachial neuritis after previous dose of tetanus toxoid-containing vaccine
  • Autoimmune disease
  • History of the vaccine-preventable disease