Contraindications Guide 508

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Guide to VaccineGuide to VaccineContraindications

and Precautions


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I

cy)

NT

RODUCTION

Guide to Vaccine Contraindications andPrecautionsTis guide summarizes CDCs recommendations regarding common symptoms and conditions that

do and do not contraindicate vaccines licensed in the United States:

Anthrax Human Papillomavirus (HPV) RotavirusBCG Influenza (IV & LAIV) dDaP Japanese Encephalitis (JE) dapD MMR yphoidHepatitis A (HA) Meningococcal Vaccines (MPSV & MCV) Vaccinia (non-emergenHepatitis B (HB) Pneumococcal Vaccines (PPV &PCV) VaricellaHaemophilus influenzaetype b Polio (IPV) Yellow Fever (YF)(Hib) Rabies Zoster

Te guide is arranged alphabetically according to symptoms and conditions which may, correctly ornot, be perceived as contraindications to vaccination.

Te first column states the Te second column lists Te third column states whethersymptom or condition. individual vaccines, when or not a person with that

recommendations differ by symptom or condition should bevaccine. vaccinated.

Notes describe exceptions and special situations, or provide additional information.

When assessing a patient with multiple symptoms, if any one of them is a contraindication,

do not vaccinate.

If there is a contraindication to any component of a combination vaccine,do not use that combination.

Contents:

Contraindications & Precautions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Notes: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Appendix A: Summary of Contents of Vaccines Licensed in the United States . . . . . . . . . . . . . . . .15Appendix B: Latex in Vaccine Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20Appendix C: Reaction After a Previous Dose of Diphtheria-, etanus-, or

Pertussis-Containing Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Appendix D: Suggested Intervals Between Administration of Immune Globulin Preparations and Measles- or Varicella-Containing Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Appendix E: Vaccinia (Smallpox) Vaccine (Routine, Non-Emergency Use) . . . . . . . . . . . . . . . . . .26Appendix F: Quick Reference - Contraindications and Precautions to Routine Childhood and Adolescent Vaccinations, By Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

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CON

TRAINDIC

ATIONS&

PRECAU

TIONS

Symptom or Condition Vaccine(s) Vaccinate?

to any vaccinecomponent (See All NoAppendix A)

HA (HAVRIX only) Noto 2-phenoxyethanol All Others Yes

HA Noto alum

All Others Yes

HB Noto yeast HPV No

All Others Yes

to duck meat or duckAll Yes

feathers

Flu No (See note 1)to eggs YF No

All Others YesMMR See Note 2

Varicella See Note 2to gelatin

Zoster NoAll Others Yes

to latex All See Appendix B

IPV NoAllergy (anaphylactic) MMR No

to neomycin Varicella NoZoster No

All Others Yes

to penicillin All Yes

IPV Noto polymyxin B

All Others Yes

to proteins of rodent or JE Noneural origin All Others Yes

IPV Noto streptomycin

All Others Yes

nonspecific orAll Yes

nonanaphylactic

in relatives All Yes

DaP See Note 3Flu (Inactivated) See Note 3

HB See Note 3to thimerosal JE No

MPSV See Note 3d/D See Note 3

All Others Yes

Anaphylactic (life-threatening) reaction toAll No (See Note 4)

previous dose of vaccine

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CON

TRAINDIC

ATIONS&

PRECAU

TIONS


Anthrax, prior infectionAnthrax

All OthersNoYes

Antimicrobial therapy (current)

Flu (LAIV only)yphoid

VaricellaZoster

All Others

Yes (See Note 5)Yes (See Note 6)

Yes (See Note 7)Yes (See Note 8)

Yes

Asplenia (anatomic or functional) All Yes

Aspirin or salicylate therapy (children oradolescents)

Flu (LAIV only)All Others

NoYes

Bleeding Disorders All Yes (See Note 9)

Breastfeeding

Vaccinate nursinginfant?

All Yes

Vaccinate lactatingmother? All Yes

Convalescing from illness All Yes

Convulsions (fits, seizures), family history(including epilepsy)

DaPAll Others

Yes (See Note 10)Yes

Diarrhea (See Illness: Concurrent)

Encephalopathy (See Reaction after a previous dose of DaP, Appendix C)

Exposure to infectious disease (recent) All Yes

Fever

Low-grade fever with orwithout mild illness

All Yes

Fever with moderate tosevere illness

All See Note 11

Guillain Barr Syndrome (GBS) (history of)

DaPFlu (LAIV)

Flu (Inactivated)MCV

ddap

All Others

See Note 12No

See Note 13No (See Note 14)

See Note 15See Note 15

Yes

Heart ConditionsFlu (LAIV only)

All OthersSee Note 16

Yes

Hematopoietic Stem Cell ransplant (HSC) All See Note 17


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HIV Infection

in recipient

(asymptomatic)

BCGFlu (LAIV only)

MMRRotavirus

yphoid (y21a only)VaricellaYF

All Others

NoNo


NoSee Note 20NoYes

in recipient(symptomatic)

BCGFlu (LAIV only)

MMRRotavirus

yphoid (y21a only)Varicella

YFZoster

All Others

NoNo


NoSee Note 20

NoSee Note 22

Yes

in household contactFlu (LAIV only)

All OthersNoYes

IG (Immune Globulin) administration, recentor simultaneous(Either intramuscular or intravenous)

MMRVaricella

All Others


Yes

Illness: Concurrent

Acute: mild (withor without low-gradefever)


See Note 25Yes

Acute: moderate tosevere (with or withoutfever)



ChronicFlu (LAIV only)

RotavirusAll Others

See Note 26See Note 27See Note 28

Immunodeficiency(See also HIVInfection andHematopoietic StemCell ransplantabove)

in recipient(hematologic and solidtumors, congenitalimmunodeficiency,long-termimmunosuppressivetherapy, includingsteroids)

BCGFlu (LAIV only)

MMRPPV

Rabies

Rotavirusyphoid (y21a only)Varicella

YFZoster

All Others

NoNoNo

Yes (See Note 29)See Note 30

See Note 19NoSee Note 31

NoSee Note 32

Yes

family historyVaricella


Yes

in household contactFlu (LAIV only)


Yes

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CON

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ATIONS&

PRECAU

TIONS


Intussusception, history ofRotavirus


Yes

Neurologic disorders, underlying (includingseizure disorders, cerebral palsy, and

developmental delay)

DaPdap

All Others


Yes

Otitis media

mild (with or withoutlow-grade fever)

All Yes

moderate or severe (withor without fever)

All See Note 11

resolving All Yes

Pregnancyin recipient

AnthraxBCG

Flu (LAIV only)HA

HPVIPVJE

MMRPPVd

dapyphoidVaricella

YFZoster

All Others

No (See Note 38)NoNo

See Note 39No (See Note 40)


No (See Note 43)See Note 44See Note 45See Note 45See Note 44

No (See Note 43)See Note 46

No (See Note 43)Yes

in mother or householdcontact of recipient

All Yes

PrematurityHB

RotavirusAll Others

Yes (See Note 47)Yes (See Note 48)Yes (See Note 49)

Reaction to a previousdose of vaccine

anaphylactic (lifethreatening)

All No (See Note 50)

local (mild-to-moderatesoreness, redness,swelling)

All Yes

Reaction after a previous dose of diphtheria-, tetanus-, or pertussis-containing vaccine(See Appendix C)

Sudden infant death syndrome (SIDS), familyhistory

All Yes

Steroids (See Immunodeficiency, p. 4)

Trombocytopenia, or history ofthrombocytopenic purpura

MMRAll Others

See Note 51Yes

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ATIONS&

PRECAU

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uberculin skin testing, performedsimultaneously with vaccination

MMRVaricella

YFAll Others

Yes (See Note 52)Yes (See Note 53)Yes (See Note 53)

Yes

uberculosis (B) or positive PPD

MMRVaricellaZoster

All Others


NoYes

Unvaccinated household contact All Yes

Vomiting

mild (with or withoutlow-grade fever)

All Yes

moderate or severe (withor without fever)

All See Note 11

Wheezing (recurrent)Flu (LAIV)All Others

See Note 56Yes

Zoster (history of ) All Yes

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NOTES

Note 1: Protocols have been published for safely administering influenza vaccine to persons withegg allergies. See Prevention and Control of Influenza, MMWR 2008;57 (No. RR-7)References 222-224.

Note 2: If vaccinating persons with a history of an anaphylactic reaction to gelatin or gelatin-containing products with MMR or its component vaccines, or with varicella vaccine,

extreme caution should be exercised. Before administering these vaccines to such persons,skin testing for sensitivity to gelatin can be considered. However, no specific protocols forthis purpose have been published.

Note 3: Some brands or formulations still contain thimerosal as a preservative, or may containtrace amounts of thimerosal that are a remnant of the manufacturing process. Check theappropriate manufacturers package insert for more information.

Note 4: Contraindicates vaccination only with vaccine to which reaction occurred.

Note 5: It is not known whether administering influenza antiviral medications affects the safetyor efficacy of live attenuated influenza vaccine (LAIV); LAIV should not be administered

until 48 hours following cessation of influenza antiviral therapy, and influenza antiviralmedications should not be administered for 2 weeks following receipt of LAIV.

Note 6: Te vaccine manufacturer advises that y21a should not be administered to personsreceiving sulfonamides or other antimicrobial agents. y21a should be administered >24hours after an antimicrobial dose. Mefloquine can inhibit the growth of the live y21astrain in vitro; if this antimalarial is administered, vaccination with y21a should be delayedfor 24 hours.

Note 7:Antiviral drugs active against herpesviruses (e.g., acyclovir or valacyclovir) might reduce theefficacy of live attenuated varicella vaccine. Tese drugs should be discontinued >24 hoursbefore the administration of varicella vaccine, if possible.

Note 8: Persons taking chronic acyclovir, famciclovir, or valacyclovir should discontinue thesemedications at least 24 hours before administration of zoster vaccine, if possible. Tesemedications should not be used for at least 14 days after vaccination, by which time theimmunologic effect should be established.

Note 9:When [any] intramuscular vaccine is indicated for a patient with a bleeding disorder or aperson receiving anticoagulant therapy, the vaccine should be administered intramuscularlyif, in the opinion of a physician familiar with the patients bleeding risk, the vaccine can beadministered with reasonable safety by this route. If the patient receives antihemophiliaor similar therapy, intramuscular vaccinations can be scheduled shortly after such therapy

is administered. A fine needle (2 minutes. Te patient or family shouldbe instructed concerning the risk for hematoma from the injection.

Note 10:Consider giving acetaminophen before DaP and every 4 hours thereafter for 24 hoursto children who have a personal or a family history of convulsions. (If an underlyingneurologic disorder is involved, also see page 5.)

Note 11:Persons with moderate or severe illnesses, with or without fever, can be vaccinated as soon asthey are recovering and no longer acutely ill.

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NO

TES

Note 12:Te decision to give additional doses of DaP to children who developed GBS within 6weeks of a prior dose should be based on consideration of the benefits of further vaccinationvs. the risk of recurrence of GBS. For example, completion of the primary series in childrenis justified.

Note 13:Whether influenza vaccination specifically might increase the risk for recurrence of GBS

is not known; therefore, avoiding vaccinating persons who are not at high risk for severeinfluenza complications and who are known to have developed GBS within 6 weeks aftera previous influenza vaccination is prudent. Although data are limited, for the majority ofpersons who have a history of GBS and who are at high risk for severe complications frominfluenza, the established benefits of influenza vaccination justify yearly vaccination.

Note 14:CDC recommends that persons with a history of GBS not receive MCV, although personswith a history of GBS at especially high risk for meningococcal disease (i.e., microbiologistsroutinely exposed to isolates ofNeisseria meningitidis) might consider vaccination.

Note 15:Not a contraindication, but providers should evaluate the risks and benefits of administeringdap or d. If a decision is made to continue vaccination with tetanus toxoid, dap is

preferred to d if otherwise indicated.

Note 16:Persons with chronic disorders of the cardiovascular system should not get live attenuatedinfluenza vaccine.

Note 17:Specific vaccines are recommended, or may be given, at varying times after transplant andunder certain circumstances. For some vaccines, no data exist. Use of live vaccines isindicated only among immunocompetent persons and is contraindicated for recipientsafter HSCT who are not presumed immunocompetent. HSC recipients are presumedimmunocompetent at >24 months after HSC if they are not on immunosuppressivetherapy and do not have graft-versus-host disease. For more information, see Guidelinesfor Preventing Opportunistic Infections Among Hematopoietic Stem Cell ransplantRecipients (MMWR 2000; 49 [No RR-10]), especially ables 4 and 6; and ACIPs GeneralRecommendations on Immunization (MMWR 2006; [No RR-15]:28).

Note 18:MMR vaccination is recommended for all asymptomatic HIV-infected persons who do nothave evidence of severe immunosuppression and for whom measles vaccination wouldotherwise be indicated. [For definition of severe immunosuppression, see 2006 AAP RedBook, able 3.25, p. 382.]

Note 19:Consider the potential risks and benefits of administering rotavirus vaccine to infantswith known or suspected altered immunocompetence. Children and adults whoare immunocompromised because of congenital immunodeficiency, hematopoietic

transplantation, or solid organ transplantation sometimes experience severe, prolonged, andeven fatal rotavirus gastroenteritis. However, no safety or efficacy data are available for theadministration of rotavirus vaccine to infants who are potentially immunocompromised,including . . . infants with primary and acquired immunodeficiency states, including HIV/AIDS or other clinical manifestations of infection with HIV. Data are insuffi cient from theclinical trials to support administration of rotavirus vaccine to infants with indeterminantHIV status who are born to mothers with HIV/AIDS.

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Note 20:Children aged 1-8: HIV-infected children with CD4+ -lymphocyte percentage >15%should be considered for vaccination with the single-antigen varicella vaccine (2 dosesadministered 3 months apart). Adolescents and adults: Data are lacking; however,weighing the risk for severe disease from wild VZV and potential benefit of vaccination,vaccination may be considered (2 doses, administered 3 months apart) for HIV-infectedpersons with CD4+-lymphocyte count >200 cells/L in these age groups. Because data

are not available on safety, immunogenicity or efficacy of MMRV vaccine in HIV infectedchildren, MMRV should not be used when vaccinating these children.

Note 21:MMR vaccination should be considered for all symptomatic HIV-infected persons who donot have evidence of severe immunosuppression or of measles immunity. [For definition ofsevere immunosuppression, see 2006 AAP Red Book, able 3.25, p. 382.]

Note 22:Zoster vaccine should not be administered to persons with primary or acquiredimmunodeficiency including persons with AIDS or other clinical manifestations of HIV,including persons with CD4+ -lymphocyte values


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NOTES

Note 27:Consider the potential risks and benefits of administering rotavirus vaccine to infants withpreexisting chronic gastrointestinal disease (e.g., congenital malabsorption syndromes,Hirschsprungs disease, short-gut syndrome, persistent vomiting of unknown cause). Infantswith chronic gastrointestinal conditions who are not undergoing immunosuppressive therapyshould benefit from rotavirus vaccine, and the benefits outweigh the theoretical risks.However, the safety and efficacy of rotavirus vaccine have not been established for infants

with these conditions.

Note 28:Te great majority of persons with chronic illnesses should be appropriately vaccinated. Tedecision whether or not to vaccinate these persons, and what vaccines to give, should bemade on an individual basis.

Note 29:When cancer chemotherapy or other immunosuppressive therapy is being considered(e.g., for patients with Hodgkins disease or those who undergo organ or bone marrowtransplantation), the interval between vaccination and initiation of immunosuppressivetherapy should be at least 2 weeks. Vaccination during chemotherapy or radiation therapyshould be avoided.

Note 30:Preexposure: Patients who are immunosuppressed by disease or medications shouldpostpone preexposure vaccinations and consider avoiding activities for which rabiespreexposure prophylaxis is indicated. When this course is not possible, immunosuppressedpersons who are at risk for rabies should be vaccinated by the IM route and their antibodytiters checked. Failure to seroconvert after the third dose should be managed in consultationwith appropriate public health officials. Postexposure: Immunosuppressive agents shouldnot be administered during postexposure therapy unless essential for treatment of otherconditions. When postexposure prophylaxis is administered to an immunosuppressedperson, it is especially important that a serum sample be tested for rabies antibody to ensurethat an acceptable antibody response has developed.

Note 31:Varicella vaccine should not be administered to persons who have cellularimmunodeficiencies, but persons with impaired humoral immunity may be vaccinated.Vaccination of leukemic children who are in remission and who do not have evidenceof immunity to varicella should be undertaken only with expert guidance and with theavailability of antiviral therapy should complications ensue. Persons without evidence ofimmunity who are receiving systemic steroids for certain conditions (e.g., asthma) and whoare not otherwise immunocompromised may be vaccinated if they are receiving


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Zoster vaccine maybe administered to: Patients whose leukemia is in remission and who have not received chemotherapy or

radiation for at least 3 months. Persons on short-term corticosteroid therapy (


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NOTES

Note 40:HPV vaccine is not recommended for use in pregnancy. It has not been causally associatedwith adverse outcomes of pregnancy or adverse events in the developing fetus. However,until additional information is available, initiation of the vaccine series should be delayeduntil after completion of the pregnancy. If a woman is found to be pregnant after initiatingthe vaccination series, the remainder of the 3-dose regimen should be delayed until aftercompletion of the pregnancy. A vaccine in pregnancy registry has been established; report

any exposure to HPV vaccine during pregnancy to 800-986-8999. No intervention isneeded.

Note 41:If a pregnant woman is at increased risk for infection and requires immediate protectionagainst polio, IPV can be administered in accordance with the recommended schedules foradults.

Note 42:Pregnant women who must travel to an area where risk of JE is high should be vaccinatedwhen the theoretical risks of immunization are outweighed by the risk of infection to themother and developing fetus.

Note 43:Women should avoid becoming pregnant for 4 weeks following vaccination.

Note 44:Vaccine is not contraindicated, but no data exist on its use among pregnant women.

Note 45:ACIP recommends d when tetanus and diphtheria protection is required during pregnancy.In some situations, health-care providers can choose to administer dap instead of d toadd protection against pertussis. When d or dap is administered during pregnancy, thesecond or third trimester is preferred. Data on safety, immunogenicity and the outcomes ofpregnancy are not available for pregnant women who receive dap. Providers who chooseto administer dap to pregnant women should discuss the lack of data with the pregnantwomen and are encouraged to report dap administration, regardless of the trimester, to theappropriate manufacturers pregnancy registry (Boostrix to GlaxoSmithKline at 1-888-8255349; Adacel to sanofi pasteur at 1-800-822-2463).

Note 46:Pregnant women should not be routinely vaccinated on theoretical grounds, and travel toareas where yellow fever is present should be postponed until after delivery. If internationaltravel requirements constitute the only reason to vaccinate a pregnant woman, rather than anincreased risk of infection, efforts should be made to obtain a waiver letter from the travelersphysician. Pregnant women who must travel to areas where the risk of yellow fever is highshould be vaccinated.

Note 47:HBsAg-Negative Mother: Preterm infants weighing


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Mothers HBsAg Status Unknown: Preterm infants weighing


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APPENDICES

Appendices:Appendix A: Summary of Contents of Vaccines Licensed in the United States . . . . . . . . . . . . . . . .15Appendix B: Latex in Vaccine Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20Appendix C: Reaction After a Previous Dose of Diphtheria-, etanus-, or

Pertussis-Containing Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Appendix D: Suggested Intervals Between Administration of Immune Globulin Preparations and Measles- or Varicella-Containing Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Appendix E: Vaccinia (Smallpox) Vaccine (Routine, Non-Emergency Use) . . . . . . . . . . . . . . . . . .26Appendix F: Quick Reference - Contraindications and Precautions to Routine Childhood and Adolescent Vaccinations, By Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

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APPENDIX

A

Summary of Contents of Vaccines Licensed inthe United StatesTe ACIP specifies that severe allergies to certain substances contraindicate specific vaccines (seeAllergies, pages 1 & 2). But ACIP also makes the general statement that a serious allergic reaction[e.g., anaphylaxis] to a vaccine component is a contraindication to any vaccine containing thatcomponent.

Tis table lists vaccine components (e.g., adjuvants and preservatives) found in all U.S. vaccines, aswell as substances used during the manufacturing process, including vaccine-production media, thatare removed from the final product and present only in trace quantities.

If in doubt about the contents of a particular vaccine, check the current package insert.In addition to the substances listed, most vaccines contain Sodium Chloride (table salt).

Vaccine Contains

Aluminum Hydroxide, Amino Acids,Anthrax (BioTrax) Benzethonium Chloride, Formaldehyde or

Formalin, Inorganic Salts and Sugars, Vitamins

Asparagine, Citric Acid, Lactose, Glycerin,BCG (ice) Iron Ammonium Citrate, Magnesium Sulfate,

Potassium Phosphate

Aluminum Phosphate, Ammonium Sulfate,Casamino Acid, Dimethyl-beta-cyclodextrin,

DaP (Daptacel)Formaldehyde or Formalin, Glutaraldehyde,

2-Phenoxyethanol

Aluminum Hydroxide, Bovine Extract,DaP (Infanrix) Formaldehyde or Formalin, Glutaraldhyde,

2-Phenoxyethanol, Polysorbate 80

Aluminum Potassium Sulfate, AmmoniumSulfate, Bovine Extract, Formaldehyde or

DaP (ripedia)Formalin, Gelatin, Polysorbate 80, SodiumPhosphate, Timerosal*

Aluminum Potassium Sulfate, Ammonium

Sulfate, Bovine Extract, Formaldehyde orDaP/Hib (riHIBit) Formalin, Gelatin, Polysorbate 80, Sucrose,Timerosal*

Aluminum Hydroxide, Bovine Extract,DaP/IPV (Kinrix) Formaldehyde, Gluteraldehyde, Monkey Kidney

Cells, Neomycin, Polymyxin B, Polysorbate 80


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APPENDIX

A

Vaccine Contains

Aluminum Hydroxide, Aluminum Phosphate,Bovine Protein, Lactalbumin Hydrolysate,Formaldehyde or Formalin, Glutaraldhyde,

DaP/HepB/IPV (Pediarix)Monkey Kidney issue, Neomycin,2-Phenoxyethanol, Polymyxin B, Polysorbate 80,Timerosal*, Yeast Protein

2-phenoxyethanol, Aluminum Phosphate, BovineSerum Albumin, Casamino Acid, Formaldehyde,

DaP/Hib/IPV (Pentacel)Gluteraldehyde, MRC-5 Cellular Protein,Neomycin, Polymyxin B, Polysorbate 80

Aluminum Potassium Sulfate, Bovine Extract,D (sanofi) Formaldehyde or Formalin, Timerosal (multi

dose) or Timerosal* (single-dose)

D (Massachusetts) Aluminum Hydroxide, Formaldehyde or Formalin

Ammonium Sulfate, Formaldehyde or Formalin,Hib (ACHib)

Sucrose

Hib (PedvaxHib) Aluminum Hydroxyphosphate Sulfate

Amino Acids, Aluminum HydroxyphosphateSulfate, Dextrose, Formaldehyde or Formalin,

Hib/Hep B (Comvax)Mineral Salts, Sodium Borate, Soy Peptone, YeastProtein

Aluminum Hydroxide, Amino Acids,Formaldehyde or Formalin, MRC-5 Cellular

Hep A (Havrix)Protein, Neomycin Sulfate, 2-Phenoxyethanol,Phosphate Buffers, Polysorbate

Aluminum Hydroxyphosphate Sulfate, BovineAlbumin or Serum, DNA, Formaldehyde or

Hep A (Vaqta)Formalin, MRC-5 Cellular Protein, SodiumBorate

Aluminum Hydroxide, Phosphate Buffers,Hep B (Engerix-B)

Timerosal*, Yeast Protein

Aluminum Hydroxyphosphate Sulfate, AminoAcids, Dextrose, Formaldehyde or Formalin,

Hep B (Recombivax)Mineral Salts, Potassium Aluminum Sulfate, SoyPeptone, Yeast Protein

Aluminum Hydroxide, Aluminum Phosphate,Amino Acids, Dextrose, Formaldehyde orFormalin, Inorganic Salts, MRC-5 Cellular

HepA/HepB (winrix)Protein, Neomycin Sulfate, 2-Phenoxyethanol,Phosphate Buffers, Polysorbate 20, Timerosal*,Vitamins, Yeast Protein16


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APPENDIX

A

Vaccine Contains

Amino Acids, Amorphous AluminumHydroxyphosphate Sulfate, Carbohydrates,

Human Papillomavirus (HPV) (Gardasil)L-histidine, Mineral Salts, Polysorbate 80, SodiumBorate, Vitamins

Beta-propiolactone, Calcium Chloride,Ovalbumin, Neomycin Sulfate, Polymyxin B,

Influenza (Afluria) Potassium Chloride, Potassium Phosphate,Sodium Phosphate, Sodium aurodeoxycholate,Timerosal (multidose containers)

Egg Albumin (Ovalbumin), Egg Protein,Formaldehyde or Formalin, Gentamicin,Hydrocortisone, Octoxynol-10, -ocopherylHydrogen Succinate, Polysorbate 80, SodiumDeoxycholate, Sodium Phosphate, Timerosal*

Influenza (Fluarix)

Egg Albumin (Ovalbumin), Egg Protein,Influenza (Flulaval) Formaldehyde or Formalin, Sodium

Deoxycholate, Phosphate Buffers, Timerosal

Beta-Propiolactone , Egg Protein, Neomycin,Polymyxin B, Polyoxyethylene 9-10 Nonyl

Influenza (Fluvirin) Phenol (riton N-101, Octoxynol 9), Timerosal(multidose containers), Timerosal* (single-dosesyringes)

Egg Protein, Formaldehyde or Formalin,

Influenza (Fluzone) Gelatin, Octoxinol-9 (riton X-100), Timerosal(multidose containers)

Chick Kidney Cells, Egg Protein, GentamicinInfluenza (FluMist) Sulfate, Monosodium Glutamate, Sucrose

Phosphate Glutamate Buffer

Calf Serum Protein, Formaldehyde orIPV (Ipol) Formalin, Monkey Kidney issue, Neomycin,

2-Phenoxyethanol, Polymyxin B, Streptomycin

Formaldehyde or Formalin, Gelatin, Mouse SerumJapanese Encephalitis (JE-Vax)

Protein, Polysorbate 80, TimerosalAmino Acid, Bovine Albumin or Serum, ChickEmbryo Fibroblasts, Gelatin, Glutamate, Human

Measles (Attenuvax)Albumin, Neomycin, Phosphate, SodiumPhosphate, Sorbitol, Sucrose, Vitamins

Meningococcal (Menactra) Formaldehyde or Formalin, Phosphate Buffers

Meningococcal (Menomune) Lactose, Timerosal (10-dose vials only)


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APPENDIX

A

Vaccine Contains

Amino Acid, Bovine Albumin or Serum, ChickEmbryo Fibroblasts, Human Serum Albumin,

Mumps (Mumpsvax)Gelatin, Glutamate, Neomycin, PhosphateBuffers, Sorbitol, Sucrose, Vitamins

Amino Acid, Bovine Albumin or Serum, ChickEmbryo Fibroblasts, Human Serum Albumin,

MMR (MMR-II)Gelatin, Glutamate, Neomycin, PhosphateBuffers, Sorbitol, Sucrose, Vitamins

Bovine Albumin or Serum, Gelatin, HumanSerum Albumin, Monosodium L-glutamate,MRC-5 Cellular Protein, Neomycin, Sodium

MMRV (ProQuad)Phosphate Dibasic, Sodium Bicarbonate, Sorbitol,Sucrose, Potassium Phosphate Monobasic,Potassium Chloride, Potassium Phosphate Dibasic

Pneumococcal (Pneumovax) Bovine Protein, Phenol

Aluminum Phosphate, Amino Acid, Soy Peptone,Pneumococcal (Prevnar)

Yeast Extract

Human Serum Albumin, Beta-Propiolactone,Rabies (Imovax) MRC-5 Cellular Protein, Neomycin, Phenol Red

(Phenolsulfonphthalein), Vitamins

Amphotericin B, Beta-Propiolactone ,Bovine Albumin or Serum, Chicken Protein,

Rabies (RabAvert) Chlortetracycline, Egg Albumin (Ovalbumin),Ethylenediamine-etraacetic Acid Sodium(EDA), Neomycin, Potassium Glutamate

Cell Culture Media, Fetal Bovine Serum,Sodium Citrate, Sodium Phosphate Monobasic

Rotavirus (Rotaeq)Monohydrate, Sodium Hydroxide Sucrose,Polysorbate 80

Amino Acids, Calcium Carbonate, Dextran,Rotavirus (Rotarix) Dulbeccos Modified Eagle Medium (DMEM),

Sorbitol, Sucrose, Xanthan

Bovine Albumin or Serum, Gelatin, HumanRubella (Meruvax II) Serum Albumin, Neomycin, Phosphate Buffers,

Sodium Phosphate, Sorbitol

Aluminum Potassium Sulfate, Bovine Extract,d (Decavac) Formaldehyde or Formalin, 2-Phenoxyethanol,

Peptone, Timerosal*

18


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APPENDIX

A

Vaccine Contains

Aluminum Hydroxide, Aluminum Phosphate,d (Massachusetts) Formaldehyde or Formalin, Timerosal (some

multidose containers)

Aluminum Phosphate, Formaldehyde or Formalin,dap (Adacel)Glutaraldehyde, 2-Phenoxyethanol

Aluminum Hydroxide, Bovine Extract,dap (Boostrix) Formaldehyde or Formalin, Glutaraldehyde,

Polysorbate 80

Disodium Phosphate, Monosodiumyphoid (inactivated yphim Vi) Phosphate, Phenol, Polydimethylsilozone,

Hexadecyltrimethylammonium Bromide

Amino Acids, Ascorbic Acid, Bovine Protein,

yphoid (oral y21a) Casein, Dextrose, Galactose, Gelatin, Lactose,Magnesium Stearate, Sucrose, Yeast Extract

Glycerin, Human Serum Albumin, Neomycin,Vaccinia (ACAM2000)

Phenol, Polymyxin B

Bovine Albumin or Serum, Ethylenediamine-etraacetic Acid Sodium (EDA), Gelatin,Monosodium L-Glutamate, MRC-5 DNA and

Varicella (Varivax)Cellular Protein, Neomycin, Potassium Chloride,Potassium Phosphate Monobasic, SodiumPhosphate Monobasic, Sucrose

Yellow Fever (YF Vax) Egg Protein, Gelatin, Sorbitol

Bovine Calf Serum, Hydrolyzed Porcine Gelatin,Monosodium L-glutamate, MRC-5 DNA and

Zoster (Zostavax) Cellular Protein, Neomycin, Potassium PhosphateMonobasic, Potassium Chloride, SodiumPhosphate Dibasic, Sucrose

August 2008

*Where thimerosal is marked with an asterisk (*) it indicates that the product should be considered equivalent to thimerosal-free

products. Tis vaccine may contain trace amounts (


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APPENDIX

B

Latex in Vaccine PackagingIf a person reports a severe (anaphylactic) allergy to latex, vaccines supplied in vials or syringes thatcontain natural rubber should not be administered, unless the benefit of vaccination outweighs therisk 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 drynatural rubber or rubber latex can be administered.

Te following table is accurate, to the best of our knowledge, as of July 2008. If in doubt, check thepackage insert for the vaccine in question.

Vaccine Latex?

Anthrax (BioTrax) YES Vial.

Comvax YES Vial

Daptacel YES Vial

YES SyringeDaP Infanrix NO Vial

ripedia YES Vial

D (Generic) YES Vial

PedvaxHIB Yes VialHib YES Diluent vial

ActHIBNO Lyophilized vaccine vial

YES SyringeHavrix

NO VialHepatitis A

YES VialVaqta

YES SyringeYES Syringe

Engerix-BHepatitis B NO Vial

Recombivax HB YES Vial

HPV (Gardasil) NO

Fluarix YES Syringe

Fluvirin NO

Fluzone NOInfluenza

FluLaval NO

FluMist NO

Afluria NO

Japanese Encephalitis (JE-Vax) NO

YES SyringeKinrix

NO Vial

MMR (M-M-R II) NO

MMRV (ProQuad) NO

Measles (Attenuvax) NO

Mumps (Mumpsvax) NO

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APPENDIX

B

21

Vaccine Latex?

Rubella (Meruvax II) NO

MeningococcalMenomune YES Vial

Menactra YES Vial

Pediarix YES SyringeNO Vial

Pentacel NO

PneumococcalPneumovax 23 NO

Prevnar YES Vial

Polio (IPOL)YES Syringe

NO Vial

RabiesImovax Rabies NO

RabAvert NO

Rotavirus Rotaeq NORotarix

YES ApplicatorNO Vial & ransfer Adapter

d

DecavacNO Vial

NO Syringe

GenericYES Vial

YES Syringe

dap

Adacel NO

BoostrixYES Syringe

NO Vial

riHIBit YES Vialwinrix

YES SyringeNO Vial

yphoidyphim Vi NO

Vivotif Berna N/A

Varicella (Varivax) NO

Vaccinia(Smallpox)

ACAM2000 NO

Yellow Fever (YF-Vax) YES Vial

Zoster (Shingles) (Zostavax) NO

July 2008


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APPENDIX

C

Reaction After a Previous Dose of Diphtheria-,etanus- or Pertussis-Containing Vaccine

Symptom or Condition Vaccine Vaccinate?

Arthus reaction, following tetanus- and/ DaP See Note C1or diphtheria toxoid-containing vaccine dap See Note C1(including MCV) d/D See Note C1

DaP See Note C2Collapse or shock-like state within 48 hours of

dap Yesdose

d/D Yes

DaP NoEncephalopathy within 7 days after dose, not

dap Noattributable to an identifiable cause

d/D Yes

DaP YesExtensive limb swelling that was not an Arthus

dap Yesreaction

d/D Yes

DaP Yes (See Note C3)Family history of any adverse event after a

dap Yesdose

d/D Yes

DaP Yes (See Note C3)Fever of 40.5C (105F) within 48 hours

dap Yesafter a dose, not attributable to another cause

d/D Yes

DaP See Note C4Guillain-Barr syndrome (GBS) within 6

dap See Note C5weeks after a dose

d/D See Note C5

Persistent, inconsolable crying lasting for 3 or DaP See Note C2

more hours, occurring within 48 hours of a dap Yesdose d/D Yes

DaP See Notes C2 & C3Seizures within 3 days after a dose dap Yes

d/D Yes

22


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APPENDIX

C

23

Note C1: Providers should carefully review the medical history to verify the diagnosis of an Arthusreaction, and can consult with an allergist or immunologist. If an Arthus reaction waslikely, consider deferring DaP, dap or d vaccination until at least 10 years have elapsedsince the last tetanus toxoid-containing and/or diphtheria toxoid-containing vaccine wasreceived. If the Arthus reaction was associated with a vaccine that contained diphtheriatoxoid without tetanus toxoid (e.g., MCV), deferring dap or d might leave the patient

inadequately protected against tetanus. In this situation, if the last tetanus toxoid-containing vaccine was >10 years earlier, providers can obtain a serum antitetanus level toevaluate the need for tetanus vaccination (antitetanus levels >0.1 IU/mL are consideredprotective) or administer .

Note C2: Not a contraindication, but a precaution. Consider carefully the benefits and risks ofthis vaccine under these circumstances. If the risks are believed to outweigh the benefits,withhold the vaccination; if the benefits are believed to outweigh the risks (for example,during an out-break or foreign travel), give the vaccine.

Note C3: Consider giving acetaminophen before DaP and every 4 hours thereafter for 24 hours.

Note C4: Te decision to give additional doses of DaP should be based on consideration of thebenefits of further vaccination vs. the risk of recurrence of GBS. For example, completionof the primary series in children is justified.

Note C5: Not a contraindication, but providers should evaluate the risks and benefits ofadministering dap or d. If a decision is made to continue vaccination with tetanustoxoid, dap is preferred to d if otherwise indicated.


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APPENDIX

D

Suggested Intervals Between Administration ofImmune Globulin Preparations and Measles- or

Varicella-Containing Vaccine (Does not include zoster

vaccine [Zostavax])

Recommendedinterval before

Dose, including mgmeasles- or

Product / Indication immunoglobulin Gvaricella-

(IgG)/kg body weightcontaining

vaccine

RSV monoclonal antibody (SynagisM)1 15 mg/kg intramuscularly (IM) None

etanus IG (IG) 250 units (10 mg IgG/kg) IM 3 months

Hepatitis A IGContact prophylaxis 0.02 mL/kg (3.3 mg IgG/kg) IM 3 monthsInternational travel 0.06 mL/kg (10 mg IgG/kg) IM 3 months

Hepatitis B IG (HBIG) 0.06 mL/kg (10 mg IgG/kg) IM 3 months

Rabies IG (HRIG) 20 IU/kg (22 mg IgG/kg) IM 4 months

Measles prophylaxis IGStandard (i.e., non- 0.25 mL/kg (40 mg IgG/kg) IM 5 months

immunocompromised) contact

Immunocompromised contact 0.50 mL/kg (80 mg IgG/kg) IM 6 months

Blood tranfusionRed blood cells (RBCs), washed 10 mL/kg negligible IgG/kg

intravenously (IV) NoneRBCs, adenine-saline added 10 mL/kg (10 mg IgG/kg) IV 3 monthsPacked RBCs (Hct 65%)2 10 mL/kg (60 mg IgG/kg) IV 6 monthsWhole blood (Hct 35%-50%)2 10 mL/kg (80-100 mg IgG/kg) IV 6 monthsPlasma/platelet products 10 mL/kg (160 mg IgG/kg) IV 7 months

Cytomegalovirus intravenous immune 150 mg/kg maximum 6 monthsglobulin (IGIV)

IGIVReplacement therapy for immune deficiencies3 300-400 mg/kg IV3 8 monthsImmune thrombocytopenic purpura 400 mg/kg IV 8 monthsImmune thrombocytopenic purpura 1000 mg/kg IV 10 monthsPostexposure varicella prophylaxis4 400 mg/kg IV 8 monthsKawasaki disease 2 g/kg IV 11 months

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APPENDIX

D

Tis table is not intended for determining the correct indications and dosages for using antibody-containing products. Unvaccinated persons might not be fully protected against measles during theentire recommended interval, and additional doses of immune globulin or measles vaccine mightbe indicated after measles exposure. Concentrations of measles antibody in an immune globulinpreparation can vary by manufacturers lot. Rates of antibody clearance after receipt of an immuneglobulin preparation also might vary. Recommended intervals are extrapolated from an estimated

half-life of 30 days for passively acquired antibody and an observed interference with the immuneresponse to measles vaccine for 5 months after a dose of 80 mg IgG/kg.

Note 1: Contains antibody only to respiratory syncytial virus.

Note 2: Assumes a serum IgG concentration of 16 mg/mL.

Note 3: Measles and varicella vaccinations are recommended for children with asymptomaticor mildly symptomatic human immunodeficiency virus (HIV) infection but arecontraindicated for persons with severe immunosuppression from HIV or any otherimmunosuppressive disorder.

Note 4: Te investigational product VariZIG, similar to licensed VZIG, is a purifi ed humanimmune globulin preparation made from plasma containing high levels of anti-varicellaantibodies (immunoglobulin class G [IgG]). When indicated, health-care providers shouldmake every effort to obtain and administer VariZIG. In situations in which administrationof VariZIG does not appear possible within 96 hours of exposure, administration ofimmune globulin intravenous (IGIV) should be considered as an alternative. IGIV alsoshould be administered within 96 hours of exposure. Although licensed IGIV preparationsare known to contain anti-varicella antibody titers, the titer of any specific lot of IGIVthat might be available is uncertain because IGIV is not routinely tested for antivaricellaantibodies. Te recommended IGIV dose for postexposure prophylaxis of varicella is 400mg/kg, administered once. For a pregnant woman who cannot receive VariZIG within96 hours of exposure, clinicians can choose either to administer IGIV or closely monitorthe woman for signs and symptoms of varicella and institute treatment with acyclovirif illness occurs. (CDC. A new product for postexposure prophylaxis available under aninvestigational new drug application expanded access protocol. MMWR 2006;55:209-10.)

Adapted from ACIP General Recommendations on Immunization, December 1, 200625


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APPENDIX

E

Vaccinia (Smallpox) Vaccine (Routine, non-emergency use*

Symptom or Condition Vaccinate with Smallpox?

Anaphylactic allergy to : Noneomycin Nopolymyxin B

Age


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Symptom or Condition Vaccinate with Smallpox?

Steroid eye drops No

Trombocytopenia, or history of thrombocytopenic purpura Yes

uberculin skin testing, performed simultaneously withvaccination Yes (See Note E7)

Household contact(i.e., can a person be vaccinated who has a household contact who):

- is allergic to a vaccine component? Yes

- is breastfeeding? Yes

- is a child or adolescent? Yes (See Note E8)

- has (or has a history of ) eczema or atopic dermatitis? No

- has HIV infection? No

- has altered immunocompetence? No

- is pregnant? No

- has an acute, chronic or exfoliative skin condition? No (See Note E6)

- has a heart condition? Yes

Note E1: Persons with inflammatory eye disease can be at increased risk for inadvertent inoculationas a result of touching or rubbing the eye. Terefore, deferring vaccination of persons withinflammatory eye diseases requiring steroid treatment is prudent until the condition resolvesand the course of therapy is complete.

Note E2:As a precaution, a patient who has been diagnosed by a doctor as having a heart conditionwith or without symptom should not get the smallpox vaccine at this time while expertscontinue their investigations. Tese conditions include known coronary disease includingprevious myocardial infarction or angina, congestive heart failure, cardiomyopathy, strokeor transient ischemic attack, chest pain or shortness of breath with activity, or other heartconditions under the care of a doctor.In addition, a patient should not get smallpox vaccine who has 3 or more of the followingfactors:- has been diagnosed with high blood pressure- has been diagnosed with high blood cholesterol- has been diagnosed with diabetes or high blood sugar- has a first degree relative who had a heart condition before the age of 50- smokes cigarettes

Note E3: Persons with moderate or severe illnesses, with or without fever, can be vaccinated as soon asthey are recovering and no longer acutely ill.

Note E4: Varicella vaccine and smallpox vaccine should be administered >4 weeks apart.

APPENDIX

E

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APPENDIX

E

Note E5: Tere is a theoretical risk that the administration of multiple live virus vaccines within 4weeks of one another, if not given on the same day, will result in a suboptimal immuneresponse. Parenterally administered live vaccines, and live attenuated influenza vaccine,when not administered on the same day, should be administered >4 weeks apart wheneverpossible. If these live vaccines are separated by 4 weeks after the last,

invalid, dose.

Note E6: Vaccination may be administered after condition resolves. (Recommendations differ foreczema and atopic dermatitis. See page 23)

Note E7: No data exist for the potential degree of PPD suppression that might be associated withparenteral live attenuated virusvaccines (other than measles). Nevertheless, in the absence of data, following guidelinesfor measles-containing vaccinewhen scheduling PPD screening and administering other parenteral live attenuated virusvaccines is prudent.

Note E8: Not a contraindication, but ACIP recognizes that programs might defer vaccination ofhousehold contacts of infants


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APPENDIX

F

Quick ReferenceContraindications and Precautions to Routine Childhood & AdolescentVaccinations BY VACCINE

For more complete and detailed information, see pages 2 through 6, or read the ACIPsrecommendations for the indivdual vaccines (www.cdc.gov/vaccines/pubs/acip-list.htm).

Contraindications and Precautions to Routine Childhood & AdolescentVaccinations BY VACCINE

DaP

Contraindications Precautions Anaphylactic reaction to a prior dose of the Moderate or severe acute illness

vaccine or any of its components Underlying unstable, evolving neurologic

Encephalopathy within 7 days of a previous disorderdose of DaP or DP (use D instead of Any of these conditions within the specifiedDaP) time after a previous dose of DaP or DP

- Fever of > 40.5C (105F) unexplained byanother cause (within 48 hours)

- Collapse or shock-like state (within 48hours)

- Persistent, inconsolable crying lasting >3hours (within 48 hours)

- Seizure or convulsion (within 72 hours)- Guillain-Barr syndrome (within 6 weeks)

dap


vaccine or any of its components History of an Arthus reaction following a Encephalopathy within 7 days of a previous previous dose of a tetanus-containing and/

dose of DaP or DP (use d instead of or diphtheria toxoid-containing vaccine,dap) including meningococcal conjugate vaccine.

Hepatitis A

Contraindications Precautions

Anaphylactic reaction to a prior dose of Moderate or severe acute illnessthe vaccine or any of its components (e.g.,2-phenoxyethanol, alum)

Hepatitis B


vaccine or any of its components (e.g., bakersyeast)

29


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APPENDIX

F


Hib


vaccine or any of its components

HPV


vaccine or any of its components (e.g., yeast). Pregnancy

Influenza (inactivated)

Contraindications Precautions Anaphylactic reaction to a prior dose of the Moderate or severe acute illnessvaccine or any of its components (e.g., eggs)

Influenza (LAIV)


vaccine or any of its components (e.g., eggs) Chronic illness of pulmonary system

(including asthma or Reactive Airway

Disease), or cardiovascular system; metabolicdisorder (e.g., diabetes); hemoglobinopathies(e.g., sickle cell disease)

Immunodeficiency Aspirin or salicylate therapy (children &

adolescents) Pregnancy History of Guillian-Barr syndrome

IPV

Contraindications Precautions Anaphylactic reaction to a prior dose of Moderate or severe acute illness

the vaccine or any of its components (e.g.,neomycin, streptomycin, polymyxin B)

MCV


vaccine or any of its components

30


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APPENDIX

F


MMR


the vaccine or any of its components (e.g., Recent administration of antibody-gelatin, neomycin) containing blood products

Pregnancy Trombocytopenia/ thrombocytopenic Immunodeficiency purpura (now or by history) Untreated active tuberculosis

PCV7


vaccine or any of its components (e.g., yeast) RotavirusContraindications Precautions Anaphylactic reaction to a prior dose of the Moderate or severe acute illness, including

vaccine or any of its components gastroenteritis Immune deficiency for any reason Administration of antibody-containing

blood products within the past 42 days Preexisting chronic GI disease History of intussusception

Varicella


the vaccine or any of its components (e.g., Recent administration of antibody-gelatin, neomycin) containing blood products

Pregnancy Immunodeficiency Untreated active tuberculosis

Zoster

Contraindications Precautions History of anaphylactic reaction to any Moderate or severe acute illness

vaccine component (e.g., gelatin, neomycin) Immunodeficiency Pregnancy

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Contraindications Guide 508

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