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Continuing Education Examination available at http://www.cdc.gov/mmwr/cme/conted.html

Recommendations and Reports / Vol. 60 / No. 2 January 28, 2011

General Recommendations on ImmunizationRecommendations of the Advisory Committee

on Immunization Practices (ACIP)

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

Morbidity and Mortality Weekly Report

http://www.cdc.gov/mmwr/cme/conted.html

http://www.cdc.gov/mmwr/cme/conted.html

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The MMWR series o publications is published by the Oice o Surveillance, Epidemiology, and Laboratory Services, Centers or Disease Control and Prevention (CDC),U.S. Department o Health and Human Services, Atlanta, GA 30333.

Suggested Citation: Centers or Disease Control and Prevention. [Title]. MMWR 2011;60(No. RR-#):[inclusive page numbers].

Centers for Disease Control and PreventionThomas R. Frieden, MD, MPH, Director

Harold W. Jae, MD, MA, Associate Director for Science James W. Stephens, PhD, Office of the Associate Director for Science

Stephen B. Thacker, MD, MSc, Deputy Director for Surveillance, Epidemiology, and Laboratory Services Stephanie Zaza, MD, MPH, Director, Epidemiology and Analysis Program Office

MMWR Editorial and Production Staff

Ronald L. Moolenaar, MD, MPH, Editor, MMWR Series Christine G. Casey, MD, Deputy Editor, MMWR Series

Teresa F. Rutledge, Managing Editor, MMWR Series

David C. Johnson, Lead Technical Writer-Editor

Catherine B. Lansdowne, MS, Project Editor

Martha F. Boyd, Lead Visual Information Specialist Malbea A. LaPete, Julia C. Martinroe,Stephen R. Spriggs, Terraye M. Starr

Visual Information Specialists Quang M. Doan, MBA, Phyllis H. King

Information Technology Specialists

MMWR Editorial Board William L. Roper, MD, MPH, Chapel Hill, NC, Chairman

Virginia A. Caine, MD, Indianapolis, IN Jonathan E. Fielding, MD, MPH, MBA, Los Angeles, CA

David W. Fleming, MD, Seattle, WA William E. Halperin, MD, DrPH, MPH, Newark, NJ

King K. Holmes, MD, PhD, Seattle, WA Deborah Holtzman, PhD, Atlanta, GA

John K. Iglehart, Bethesda, MDDennis G. Maki, MD, Madison, WI

Patricia Quinlisk, MD, MPH, Des Moines, IA Patrick L. Remington, MD, MPH, Madison, WI

Barbara K. Rimer, DrPH, Chapel Hill, NC John V. Rullan, MD, MPH, San Juan, PR

William Schaner, MD, Nashville, TN Anne Schuchat, MD, Atlanta, GA

Dixie E. Snider, MD, MPH, Atlanta, GA John W. Ward, MD, Atlanta, GA

Disclosure of Relationship

CDC, our planners, and our content experts wish to disclose that they have no inanciainterests or other relationships with the manuacturers o commercial products, suppliers o commercial services, or commercial supporters. This report will not includany discussion o the unlabeled use o a product or a product under investigationause with the exception o the ollowing situations:

1. The nonsimultaneous administration o yellow ever (YF) vaccine and inactivatedvaccines.

2. Simultaneous administration o an inactivated and live vaccine (e.g., pneumococcapolysaccharide vaccine [PPSV] and zoster [Zos] vaccine).3. Interchangeability o combination vaccines and single-component vaccines (e.g.

using single-component Haemophilus influenzae type b [Hib], diphtheria andtetanus toxoids and acellular pertussis (DTaP), and inactivated poliovirus [IPVor later doses in series, ater a series has begun with DTaP-IPV/Hib).

4. Interchangeability o brands o combination vaccines and single-componenvaccines (e.g., using DTaP-IPV/Hib and single-component hepatitis B [Hep Bvaccine or later doses in series that might have previously included DTaP-IPVHepB and Hib).

5. Rotarix and RotaTeq need not be repeated i an inant spits up or regurgitates a dose.6. Contact allergy to latex is neither a contraindication nor a precaution to the us

o quadrivalent meningococcal conjugate vaccine (MCV4) in the absence o ananaphylactic allergy.

7. No need to repeat a dose o MCV4 vaccine given subcutaneously.8. Revaccination with MCV4.9. Appropriate storage and handling or the ollowing vaccines at 35°F–46°F:

• DTaP• Hib• HepatitisA• HepatitisB• Humanpapillomavirus(HPV)• PPSV

• Measles,mumps,andrubella(MMR)• Pneumococcalconjugatevaccine(PCV)• Rotavirus(RV)• Tetanustoxoid,reduceddiphtheriatoxoid,

and acellular pertussis (Tdap) vaccine• Trivalentinactivatedinfluenzavaccine(TIV)

10. Initiation o live Zos vaccine in immunocompetent patients 3 months ater remissionrom chemotherapy.

11. Avoiding conception or 1 month ater vaccination with MMR or varicella (Varvaccine.

12. A minimum age o 12 months or the ourth dose o DTaP.13. Use o pneumococcal conjugate vaccine and Haemophilus influenzae b vaccine in

persons receiving hematopoietic cell transplant or who are inected with humanimmunodeiciency virus, regardless o age.

There is no commercial support or this activity.

Credit: Constant Joseph Desbordes (1761–1827), Baron Jean Louis Alibert (1768–1837) performing the vaccination against smallpox in the Château of Liancourt (detail)c. 1820, French. Oil on canvas. Courtesy: Musée de l’Assistance Publique — Hôpitaux de Paris, Paris, France / Archives Charmet / The Bridgeman Art Library.

CONTENTS

Introduction ............................................................................................................3

Methods....................................................................................................................4

Timing and Spacing o Immunobiologics ....................................................4

Contraindications and Precautions.............................................................. 10

Preventing and Managing Adverse Reactions......................................... 11

Vaccine Administration .................................................................................... 13

Storage and Handling o Immunobiologics ............................................. 17

Altered Immunocompetence ........................................................................ 19

Special Situations ............................................................................................... 23

Vaccination Records .......................................................................................... 30

Vaccination Programs ....................................................................................... 31

Vaccine Inormation Sources ......................................................................... 34

Acknowledgments ............................................................................................. 35

Reerences ............................................................................................................. 52

Abbreviations ...................................................................................................... 59

Glossary.................................................................................................................. 60

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Recommendations and Reports

MMWR / January 28, 2011 / Vol. 60 / No. 2 3

General Recommendations on Immunization

Recommendations of the Advisory Committee on ImmunizationPractices (ACIP)

Prepared by

Andrew T. Kroger, MD1

Ciro V. Sumaya, MD2

Larry K. Pickering, MD1

William L. Atkinson, MD1

1National Center for Immunization and Respiratory Diseases 2 Texas A&M Health Science Center, College Station, Texas

Summary

This report is a revision of the General Recommendations on Immunization and updates the 2006 statement by the Advisory Committee on Immunization Practices (ACIP) (CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55[No. RR-15]). The report also includes revised content from previ-ous ACIP recommendations on the following topics: adult vaccination (CDC. Update on adult immunization recommendations of the

immunization practices Advisory Committee [ACIP]. MMWR 1991;40[No. RR-12]); the assessment and feedback strategy to increase vaccination rates (CDC. Recommendations of the Advisory Committee on Immunization Practices: programmatic strategies to increase vaccination rates—assessment and feedback of provider-based vaccination coverage information. MMWR 1996;45:219–20); linkage of vaccination services and those of the Supplemental Nutrition Program for Women, Infants, and Children (WIC program) (CDC.Recommendations of the Advisory Committee on Immunization Practices: programmatic strategies to increase vaccination coverage by age 2 years—linkage of vaccination and WIC services. MMWR 1996;45:217–8); adolescent immunization (CDC. Immunizationof adolescents: recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. MMWR 1996;45[No. RR-13]); and combinationvaccines (CDC. Combination vaccines for childhood immunization: recommendations of the Advisory Committee on ImmunizationPractices [ACIP], the American Academy of Pediatrics [AAP], and the American Academy of Family Physicians [AAFP]. MMWR 1999;48[No. RR-5]).

Notable revisions to the 2006 recommendations include 1) revisions to the tables of contraindications and precautions to vaccination,

as well as a separate table of conditions that are commonly misperceived as contraindications and precautions; 2) reordering of the report content, with vaccine risk-benefit screening, managing adverse reactions, reporting of adverse events, and the vaccine injury compensation program presented immediately after the discussion of contraindications and precautions; 3) stricter criteria for selecting an appropriate storage unit for vaccines; 4) additional guidance for maintaining the cold chain in the event of unavoidable temperature deviations; and 5) updated revisions for vaccination of patients who have received a hematopoietic cell transplant. The most recent ACIP recommenda-tions for each specific vaccine should be consulted for comprehensive details. This report, ACIP recommendations for each vaccine, and additional information about vaccinations are available from CDC at http://www.cdc.gov/vaccines .

IntroductionCDC recommends routine vaccination to prevent 17

vaccine-preventable diseases that occur in inants, children,adolescents, or adults. This report provides inormation or

clinicians and other health-care providers about concerns thatcommonly arise when vaccinating persons o various agesProviders and patients encounter numerous issues, such as

the timing o each dose, screening or contraindications andprecautions, the number o vaccines to be administered, theeducational needs o patients and parents, and interpretingand responding to adverse events. Vaccination providers helppatients understand the substantial, occasionally conlictinginormation about vaccination. These vaccination recom-mendations are intended or clinicians and other health-careproviders who vaccinate patients.

The material in this report originated in the National Center orImmunization and Respiratory Diseases, Anne Schuchat, MD,Director.Corresponding preparer: Andrew Kroger, MD, National Center orImmunization and Respiratory Diseases, 1600 Cliton Rd., MS E-52,

Atlanta, GA 30333. Telephone: 404-639-1958; Fax: 404-639-8828;E-mail: [email protected] .

http://www.cdc.gov/vaccines

mailto:[email protected]



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4 MMWR / January 28, 2011 / Vol. 60 / No. 2

The guidance in this report will help vaccination provid-ers to assess vaccine beneits and risks, use recommendedadministration and storage practices, understand the mosteective strategies or ensuring that vaccination coverage in thepopulation remains high, and communicate the importanceo vaccination to reduce the eects o vaccine-preventable

disease. These recommendations are intended or use in theUnited States; vaccine availability, use, and epidemiologic cir-cumstances might dier in other countries and might warrantdierent recommendations.

MethodsThe Advisory Committee on Immunization Practices (ACIP)

General Recommendations Work Group (GRWG) revises theGeneral Recommendations on Immunization every 3 to 5 years.Relevant topics are those identiied by ACIP as topics that relate

to all vaccines, including timing and spacing o doses, vaccineadministration, and vaccine storage and handling. New topicsoten are added when ACIP decides that previous ACIP state-ments on general issues such as combination vaccines, adolescentvaccination, or adult vaccination should be revised and combined with the General Recommendations on Immunization.

The recommendations in this report are based not only on available scientiic evidence but also on expertise thatcomes directly rom a diverse group o health-care providersand public health oicials. GRWG includes proessionalsrom academic medicine (pediatrics, amily practice, andpharmacy); international (Canada), ederal, and state public

health proessionals; and a member rom the nongovernmentalImmunization Action Coalition. GRWG, which met monthly beginning June 2007, ormed subgroups on the basis o inter-est in topics such timing and spacing, vaccine administration,and storage and handling. These subgroups also met monthly,conducted literature reviews, and contributed expert opinionon the need or revisions to speciic language. In October 2008,GRWG consulted ACIP to determine the best mechanism orapproving the resulting document. ACIP concluded that thedocument could be approved and inalized incrementally, witha inal vote on the entire document.

Revisions to the ollowing sections were approved through con-

sensus vote in October 2008 (i.e., were approved as a part o theentire document and not through separate votes on each section):1) Timing and Spacing o Immunobiologics; 2) Contraindicationsand Precautions; 3) Preventing and Managing Adverse Reactions;4) Reporting Vaccine Adverse Events; 5) the National VaccineInjury Compensation Program; and 6) Vaccine Administration.In February 2009, revisions were made to Storage and Handlingo Immunobiologics, and ACIP approved the section. In June

2009, ACIP voted to incorporate the contents o a 1999 ACIPstatement on combination vaccines. The statement was revisedby GRWG and the ACIP Combination Vaccines Work Group ACIP also approved minor changes to the section on SpeciaSituations and the section on Vaccination Records. In October2009, ACIP voted to revise the entire General Recommendation

on Immunization, which incorporated ACIP recommendations onadolescent vaccination (1996) and adult vaccination (1991) intothe section on Vaccination Programs. Three votes were taken toapprove various sections o the document, and one vote was takento approve the entire document. At this inal meeting, ACIP alsodiscussed concerns about the lack o evidence that supports use oantipyretics beore or at the time o vaccination or the preventiono ever. Consequently, CDC added inormation highlightingthe lack o evidence or the use o antipyretics to the section onMethods or Alleviating Discomort and Pain Associated withVaccination. The last meeting o GRWG was held on December2, 2009. This meeting served solely to update the work groupregarding the discussions and vote o the October 2009 meetingand CDC deliberations on changes to the recommendations onthe use o antipyretics.

Timing and Spacingof Immunobiologics

General Principles for Vaccine SchedulingOptimal response to a vaccine depends on multiple actors

including the type o vaccine, age o the recipient, and immune

status o the recipient. Recommendations or the age at whichvaccines are administered are inluenced by age-speciic risksor disease, age-speciic risks or complications, age-speciicresponses to vaccination, and potential intererence with theimmune response by passively transerred maternal antibodiesVaccines are recommended or members o the youngest agegroup at risk or experiencing the disease or which eicacyand saety have been demonstrated.

Certain products, including inactivated vaccines, toxoidsrecombinant subunit vaccines, polysaccharide conjugate vaccinesand live vaccines, require ≥2 doses to elicit an adequate antibodyresponse. Tetanus and diphtheria toxoids require booster dosesto maintain protective antibody concentrations. Unconjugatedpolysaccharide vaccines do not induce T-cell memory, and addi-tional doses (although they elicit the same or a lower antibodyconcentration) might increase the level o protection. Conjugation with a protein carrier improves the eectiveness o polysaccharidevaccines by inducing T-lymphocyte–dependent immunologicunction. Many vaccines that stimulate both cell-mediatedimmunity and neutralizing antibodies (e.g., live, attenuated virus

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vaccines) usually can induce prolonged immunity, even i antibody titers decline over time (1). Subsequent exposure to such virusesusually results in a rapid anamnestic antibody response withoutviremia.

Approximately 90%–95% o recipients o a single dose o certain live vaccines administered by injection at the recom-

mended age (i.e., measles, rubella, and yellow ever vaccines)develop protective antibodies, generally within 14 days o thedose. For varicella and mumps vaccines, 80%–85% o vac-cinees are protected ater a single dose. However, because alimited proportion (5%–15%) o measles, mumps, and rubella(MMR) or varicella vaccinees ail to respond to 1 dose, a sec-ond dose is recommended to provide another opportunity todevelop immunity ( 2 ). O those who do not respond to theirst dose o MMR or varicella vaccine, 97%–99% respond toa second dose ( 3,4 ).

The Recommended Immunization Schedules for Persons Aged 0 Through 18 Years and the Recommended Adult ImmunizationSchedule are revised annually. Physicians and other health-careproviders should ensure that they are ollowing the most up-to-date schedules, which are available rom CDC at http:// www.cdc.gov/vaccines.

Spacing of Multiple Dosesof the Same Antigen

Vaccination providers should adhere as closely as possible torecommended vaccination schedules (Table 1). Administrationat recommended ages and in accordance with recommendedintervals between doses o multidose antigens provide optimalprotection.

Administration o doses o a multidose vaccine using inter-vals that are shorter than recommended might be necessary incertain circumstances, such as impending international travelor when a person is behind schedule on vaccinations but needsrapid protection. In these situations, an accelerated schedulecan be implemented using intervals between doses that areshorter than intervals recommended or routine vaccination.The accelerated or minimum intervals and ages or schedul-ing catch-up vaccinations are available at http://www.cdc.gov/vaccines. Vaccine doses should not be administered at intervals

less than these minimum intervals or at an age that is youngerthan the minimum age.*

Beore administering a vaccine dose, providers might needto veriy that all previous doses were administered ater theminimum age and in accordance with minimum intervals(Table 1). In clinical practice, vaccine doses occasionally areadministered at intervals less than the minimum interval or atages younger than the minimum age. Doses administered too

close together or at too young an age can lead to a suboptimaimmune response. However, administering a dose a ew daysearlier the minimum interval or age is unlikely to have a sub-stantially negative eect on the immune response to that doseVaccine doses administered ≤4 days beore the minimum inter-val or age are considered valid; however, local or state mandatesmight supersede this 4-day guideline.† (Day 1 is the day beorethe day that marks the minimum age or minimum interval ora vaccine.) Because o the unique schedule or rabies vaccinethe 4-day guideline does not apply to this vaccine (5 ). Doseso any vaccine administered ≥5 days earlier than the minimuminterval or age should not be counted as valid doses and shouldbe repeated as age appropriate. The repeat dose should bespaced ater the invalid dose by the recommended minimuminterval (Table 1). For example, i the irst and second doses oHaemophilus influenzae type b (Hib) were administered only14 days apart, the second dose would be invalid and need to berepeated because the minimum interval rom dose 1 to dose 2is 4 weeks. The repeat dose should be administered ≥4 weeksater the invalid dose (in this case, the second). The repeat doseis counted as the valid second dose.

I the irst dose in a series is given ≥5 days beore the recom-mended minimum age, the dose should be repeated on or ater

the date when the child reaches at least the minimum age. Ithe vaccine is a live vaccine, ensuring that a minimum intervao 28 days has elapsed rom the invalid dose is recommendedFor example, i the irst dose o varicella vaccine were inadver-tently administered at age 10 months, the repeat dose wouldbe administered no earlier than the child’s irst birthday (theminimum age or the irst dose). I the irst dose o varicellavaccine were administered at age 11 months and 2 weeks, therepeat dose should be administered no earlier than 4 weeksthereater, which would occur ater the irst birthday.

Certain vaccines (e.g., adult tetanus and diphtheria toxoids[Td], pediatric diphtheria and tetanus toxoids [DT]; and teta-

nus toxoid) produce increased rates o local or systemic reac-tions in certain recipients when administered more requentlythan recommended (6,7 ). Careul record keeping, maintenance

† In certain situations, local or state requirements might mandate that doses oselected vaccines be administered on or ater speciic ages. For example, a schooentry requirement might not accept a dose o MMR or varicella vaccine ad-ministered beore the child’s irst birthday. ACIP recommends that physicianand other health-care providers comply with local or state vaccination requirements when scheduling and administering vaccines.

* During measles outbreaks, i cases are occurring among inants aged <12 months,measles vaccination o inants as young as 6 months can be used as an outbreak control measure. However, doses administered at ages <12 months should not becounted as part o the series (Source: CDC. Measles, mumps, and rubella vaccineuse and strategies or elimination o measles, rubella, and congenital rubella syn-drome and control o mumps: recommendations o the Advisory Committee onImmunization Practices [ACIP]. MMWR 1998;47[No. RR-8]).









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o patient histories, use o immunization inormation systems(IISs), and adherence to recommended schedules can decreasethe incidence o such reactions without adversely aectingimmunity.

Simultaneous AdministrationSimultaneous administration o vaccines is deined as

administering more than one vaccine on the same clinic day,at dierent anatomic sites, and not combined in the samesyringe. Experimental evidence and extensive clinical experi-ence provide the scientiic basis or administering vaccinessimultaneously. Simultaneously administering all vaccines or which a person is eligible at the time o a visit increases theprobability that a child, adolescent, or adult will be vaccinatedully by the appropriate age (8 ). A study conducted during ameasles outbreak demonstrated that approximately one thirdo measles cases among unvaccinated but vaccine-eligible

preschool children might have been prevented i MMR hadbeen administered at the same visit when another vaccine wasadministered (9 ). Simultaneous administration also is criti-cal when preparing or oreign travel and when a health-careprovider is uncertain that a patient will return or additionaldoses o vaccine.

With some exceptions, simultaneously administering themost widely used live and inactivated vaccines has producedseroconversion rates and rates or adverse reactions similar tothose observed when the vaccines are administered separately (10–13). Routine administration o all age-appropriate doseso vaccines simultaneously is recommended or children or

whom no speciic contraindications exist at the time o thevisit. MMR and varicella vaccine can be administered simul-taneously. Live, attenuated inluenza vaccine (LAIV) doesnot interere with the immune response to MMR or varicellavaccines administered at the same visit. No data exist aboutthe immunogenicity o oral Ty21a typhoid vaccine whenadministered concurrently or within 30 days o live virus vac-cines. In the absence o such data, i typhoid vaccination is warranted, administration should not be delayed because o recent administration o live, attenuated virus vaccines (14 ).Simultaneous administration o pneumococcal polysaccharidevaccine (PPSV) and inactivated inluenza vaccine elicits a satis-actory antibody response without increasing the incidence orseverity o adverse reactions (15 ). Simultaneous administrationo PPSV and inactivated inluenza vaccine is recommendedor all persons or whom both vaccines are indicated. Tetanustoxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap)and trivalent inactivated inluenza vaccine (TIV) can be admin-istered simultaneously (16 ). Hepatitis B vaccine administered with yellow ever vaccine is as sae and immunogenic as when

these vaccines are administered separately (17 ). Measles andyellow ever vaccines have been administered saely at the samevisit and without reduction o immunogenicity o either othe components (18,19 ).

Depending on which vaccines are administered during theirst year o lie, a child might receive up to nine injections

at the 12- through 15-month visit (MMR, varicella, Hibpneumococcal conjugate vaccine [PCV], pediatric diphtheriaand tetanus toxoids and acellular pertussis [DTaP], inacti-vated poliovirus [IPV], hepatitis A, hepatitis B, and inluenzavaccines). Although there is no exact limit on the number oinjections, with a little lexibility, a provider can ensure thatthe primary series doses are given without administering toomany injections at each visit. To reduce the number o injec-tions at the 12- through 15-month visit, the hepatitis B seriesand 3 doses o IPV ( 20 ) can be administered beore the child’irst birthday.

There are many other examples o ways the vaccinationschedule provides lexibility. The majority o children aged 1year who have received 2 Hib vaccine doses (polyribosylribitophosphate-meningococcal outer membrane protein [PRP-OMP]) or 3 Hib vaccine doses (PRP-tetanus [PRP-T]) and 3previous doses o DTaP and PCV have protection against Hibdiphtheria, pertussis, tetanus, and pneumococcus, which laststhroughout inancy ( 21,22 ). The third (PRP-OMP) or ourth(PRP-T) dose o the Hib series and the ourth doses o DTaPand PCV are critical in boosting antibody titer and ensuringcontinued protection ( 22–25 ). The ourth dose o DTaP is rec-ommended at age 15–18 months but may be administered as

early as age 12 months i 6 months have elapsed since the thirddose and i there is concern that the child might not return byage 18 months ( 23). For inants at low risk or inection withhepatitis B virus (i.e., mother tested negative or hepatitis Bsurace antigen [HBsAg] at the time o delivery and is not ina high risk group), the hepatitis B series can be completed atany time or children aged 6–18 months ( 26 ). The minimumage or administration o combination vaccines is the oldestminimum age or any o the individual components; the mini-mum interval between doses is equal to the greatest minimuminterval o any o the individual components. With use o thecombination Hib-hepatitis B vaccine, the minimum age o

administration o the inal dose is 12 months because o theminimum age requirement or the last dose o the Hib series( 26 ). Recommended spacing o doses should be maintained(Table 1).

Combination VaccinesCombination vaccines merge equivalent component vac-

cines into single products to prevent more than one disease

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or to protect against multiple strains o inectious agentscausing the same disease. Licensed combination vaccines canbe used whenever any components o the combination areindicated and its other components are not contraindicatedand i licensed by the Food and Drug Administration (FDA)or that dose in the series. Use o combination vaccines can

reduce the number o injections patients receive and alleviateconcern associated with the number o injections ( 20,27,28 ).Studies have demonstrated that parents and providers mightbe uncomortable with multiple injections during single visits( 29–31). Potential advantages o combination vaccines include1) improved vaccine coverage rates ( 32 ), 2) timely vaccinationcoverage or children who are behind the schedule ( 33,34 ), 3) reduced shipping and stocking costs, 4) reduced costs orextra health-care visits necessitated by deerral o vaccination,and 5) acilitation o additional new vaccines into vaccinationprograms.

Potential disadvantages o combination vaccines include theollowing: 1) adverse events that might occur more requently ater administration o a combination vaccine compared withadministration o separate antigens at the same visit, suchas those that occur with the combination measles, mumps,rubella, and varicella (MMRV) vaccine and combinationDTaP-hepatitis B-IPV vaccine ( 35,36 ); 2) conusion and uncer-tainty about selection o vaccine combinations and schedulesor subsequent doses, especially when vaccinations are givenby multiple providers who might be using dierent products;3) reduced immunogenicity o one or more components ( 37 );4) extra doses o certain antigens in the ixed product (e.g., a

provider who uses DTaP-hepatitis B-IPV vaccine will give anextra dose o hepatitis B component); and 5) a shorter shel-lie than the individual component vaccines. The economicimpact o the use o combination vaccines is unclear becausecombination products have the potential or either increasedor decreased costs compared with single-antigen componentvaccines. The price o a combination vaccine might exceed thetotal price o separate vaccines containing the same antigens.However, combination vaccines might represent a better overalleconomic value i the direct and indirect costs o extra injec-tions, delayed or missed vaccinations, and additional handlingand storage are taken into consideration ( 38 ).

Licensed Combination Vaccines

In this report, a combination vaccine is deined as a prod-uct containing components that can be divided equally intoindependently available routine vaccines. A dash ( - ) betweenvaccine products indicates that products are supplied in theirinal orm by the manuacturer and do not require mixingor reconstitution by the user. A slash ( / ) indicates that theproducts must be mixed or reconstituted by the user. Seven

combination vaccines or which separate antigens or antigencombinations exist have been licensed by FDA since 1996 inthe United States (Table 2) ( 39–45 ). In the uture, combina-tion vaccines might include increasing numbers o componentsin dierent arrays to protect against these and other diseases(The status o licensure and recommendations or new vac-

cines is available at http://aapredbook.aappublications.org/news/vaccstatus.shtml.) The use o a combination vaccinegenerally is preerred over separate injections o the equivalentcomponent vaccines. Considerations should include providerassessment,§ patient preerence, and the potential or adverseevents. An exception is the irst dose o MMRV. Unless theparent or caregiver expresses a preerence or MMRV vaccineMMR and varicella vaccine should be administered or theirst dose or children aged 12–47 months ( 35 ).

Situations might arise in which one component o a com-bination vaccine is speciically preerred to another compo-nent in that same vaccine. Future research considerations onewly licensed combination vaccines should ocus on saetyo doses that are not needed because a patient is already vac-cinated against the agents, whether the combination vaccine will improve the timeliness o vaccination, and potentiareduced costs rom disease prevention resulting rom timelyvaccination.

Combination Vaccines and FDA Licensure

Only combination vaccines licensed by FDA should be usedVaccination providers should not combine separate vaccinesinto the same syringe to administer together unless mixing is

indicated or the patient’s age and is explicitly speciied on theFDA-approved product label inserts. Only two combinationvaccines (DTaP-IPV/Hib vaccine, marketed as Pentacel, andDTaP/Hib, marketed as TriHibit) contain separate antigencomponents or which FDA approves mixing by the userThe saety, immunogenicity, and eectiveness o unlicensedcombinations are unknown.

Interchangeability of Formulations

FDA generally licenses a combination vaccine based onstudies demonstrating that the product’s immunogenicity (oreicacy) and saety are comparable or equivalent to monova

lent or combination products licensed previously (46 ). FDAlicensure also generally indicates that a combination vaccinemay be used interchangeably with monovalent ormulationsand other combination products with similar componenantigens produced by the same manuacturer to continue thevaccination series. For example, DTaP, DTaP/Hib, and uture

§ Provider assessment should include number o injections, vaccine availabilitylikelihood o improved coverage, likelihood o patient return, and storage andcost considerations.

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DTaP vaccines that contain similar acellular pertussis antigensrom the same manuacturer may be used interchangeably i licensed and indicated or the patient’s age (45 ).

Interchangeability of Combination Vaccines fromDifferent Manufacturers

Licensure o a vaccine by FDA does not necessarily indicatethat the vaccine is interchangeable with products rom othermanuacturers. Such data are ascertained and interpreted morereadily or diseases with known correlates o protective immu-nity (e.g., speciic serologic markers). For diseases withoutsuch surrogate laboratory markers, prelicensure ield vaccineeicacy (phase III) trials or postlicensure surveillance generally are required to determine protection (47 ). ACIP preers thatdoses o vaccine in a series come rom the same manuacturer;however, i this is not possible or i the manuacturer o dosesgiven previously is unknown, providers should administer thevaccine that they have available.

Vaccine Supply

Although vaccination providers should stock suicientquantities o combination and monovalent vaccines needed tovaccinate children, adolescents, and adults against all diseasesor which vaccines are recommended ( 20,28 ), all availabletypes or brand-name products need not be stocked. Potentialadvantages o stocking a limited number o vaccines include1) reducing conusion and potential errors when sta mem-bers must handle redundant products and ormulations, 2)minimizing waste when less commonly used products expire,

3) decreasing cold storage capacity requirements, and 4) mini-mizing administrative costs related to accounting, purchasing,and handling.

Extra Doses of Vaccine Antigens

Administering extra antigens contained in a combinationvaccine should be avoided in most situations. Using combina-tion vaccines containing certain antigens not indicated at thetime o administration to a patient might be justiied when1) the extra antigen is not contraindicated, 2) products thatcontain only the needed antigens are not readily available,and 3) potential beneits to the patient outweigh the potential

risk or adverse events associated with the extra antigens. Anextra dose o many live-virus vaccines and Hib or hepatitis Bvaccine has not been ound to be harmul (48 ). However, therisk or an adverse event might increase when extra doses areadministered at an earlier time than the recommended intervalor certain vaccines (e.g., tetanus toxoid vaccines and PPSV)(16,24,49 ).

A vaccination provider might not have vaccines availablethat contain only the antigens needed as indicated by a child’s

vaccination history. Alternatively, although the indicated vac-cines might be available, the provider might preer to use acombination vaccine to reduce the required number o injections. In such cases, the beneits and risks o administering thecombination vaccine with an unneeded antigen should be care-ully considered and discussed with the patient or parent.

When inactivated (i.e., killed), or particularly subunit vac-cines (which are oten adsorbed to aluminum-salt adjuvants)are administered, the reactogenicity o the vaccine must beconsidered in balancing the beneits and risks o extra dosesBecause clinical experience suggests low reactogenicity, an extradose o Hib or hepatitis B vaccine may be administered as parto a combination vaccine to complete a vaccination series oanother component o the combination. Administration oextra doses o tetanus toxoid vaccines earlier than the recommended intervals can increase the risk or hypersensitivityreactions (16,24,50 ). Examples o such vaccines include DTaPDTaP/Hib, DT (or children), Td (or adolescents and adults)and Tdap. Extra doses o tetanus-toxoid–containing vaccinemight be appropriate or certain patients, including or children who previously received DT or Td vaccine and need protec-tion rom pertussis (in DTaP or Tdap) or or immigrants withuncertain vaccination histories.

Conjugate Vaccine Carrier Proteins

Certain carrier proteins in existing conjugated Hib vaccinealso are used as components o other vaccines (e.g., pneumo-coccal and meningococcal vaccines) (51). Protein conjugatesused in Hib conjugate vaccines produced in the United State

include an outer membrane protein complex rom Neisseriameningitidis (in PRP-OMP), and tetanus toxoid (in PRP-T)Simultaneous administration o quadrivalent meningococcaconjugate vaccine (MCV4), PCV, and Tdap, all o which con-tain diphtheria toxoid, is not associated with reduced immu-nogenicity or an increase in local adverse events ( 24,51).

Nonsimultaneous AdministrationThere is no evidence that inactivated vaccines interere with

the immune response to other inactivated vaccines or to livevaccines. Any inactivated vaccine can be administered eithersimultaneously or at any time beore or ater a dierent inac-tivated vaccine or live vaccine (Table 3).

Limited data are available regarding intererence between livevaccines used in the United States. The immune response toone live-virus vaccine might be impaired i administered within28 days (i.e., 4 weeks) o another live-virus vaccine (52,53). Ina study conducted in two U.S. health maintenance organiza-tions, the risk or varicella vaccine ailure (i.e., varicella diseasein a vaccinated person) among persons who received varicella

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vaccine within 28 days o MMR vaccination was threeoldhigher than among persons who received varicella vaccine >28days ater MMR vaccination (54 ). Another study determinedthat the response to yellow ever vaccine is not aected by monovalent measles vaccine administered 1–27 days earlier(18 ). The eect o nonsimultaneous administration o rubella,

mumps, varicella, and yellow ever vaccines is unknown.To minimize the potential risk or intererence, injectable

or nasally administered live vaccines not administered on thesame day should be administered ≥4 weeks apart (Table 3). I injectable or nasally administered live vaccines are separatedby <4 weeks, the second vaccine administered should not becounted as a valid dose and should be repeated. The repeat doseshould be administered ≥4 weeks ater the last invalid dose.Oral vaccines (Ty21a typhoid vaccine and rotavirus) can beadministered simultaneously or at any interval beore or aterother live vaccines (injectable or intranasal) i indicated.

Spacing of Vaccines andAntibody-Containing Products

Live Vaccines

Ty21a typhoid, yellow ever, LAIV, zoster, and rotavirusvaccines may be administered at any time beore, concurrent with, or ater administration o any immune globulin, hyper-immune globulin, or intravenous immune globulin (IGIV)(55 ). Blood (e.g., whole blood, packed red blood cells, andplasma) and other antibody-containing blood products (e.g.,immune globulin, hyperimmune globulin, and IGIV) can

inhibit the immune response to measles and rubella vaccinesor ≥3 months. The eect o blood and immune globulinpreparations on the response to mumps and varicella vaccines isunknown; however, commercial immune globulin preparationscontain antibodies to these viruses. Blood products available inthe United States are unlikely to contain a substantial amounto antibody to yellow ever vaccine virus. The length o timethat intererence with injectable live-virus vaccine (other thanyellow ever) can persist ater the antibody-containing productis a unction o the amount o antigen-speciic antibody con-tained in the product (56–58 ). Thereore, ater an antibody-containing product is received, live vaccines (other than yellow ever, oral Ty21a typhoid, LAIV, zoster, and rotavirus) shouldbe delayed until the passive antibody has degraded (Table 4).I a dose o injectable live-virus vaccine (other than yellow ever and zoster) is administered ater an antibody-containingproduct but at an interval shorter than recommended in thisreport, the vaccine dose should be repeated unless serologictesting is easible and indicates a response to the vaccine. Therepeat dose or serologic testing should be perormed ater

the interval indicated or the antibody-containing product(Table 5).

Although passively acquired antibodies can interere withthe response to rubella vaccine, the low dose o anti-Rho(D)globulin administered to postpartum women has not beendemonstrated to reduce the response to the RA27/3 strain

rubella vaccine (59 ). Because o the importance o rubellaand varicella immunity among women o child-bearing age(4,60 ), the postpartum vaccination o women without evidenceo immunity to rubella or varicella with MMR, varicella, orMMRV vaccines should not be delayed because o receipt oanti-Rho(D) globulin or any other blood product during thelast trimester o pregnancy or at delivery. These women shouldbe vaccinated immediately ater giving birth and, i possibletested ≥3 months later to ensure immunity to rubella and, iappropriate, to measles ( 2 ).

Intererence might occur i administration o an antibody-containing product becomes necessary ater administration oMMR or varicella vaccines. Usually, vaccine virus replicationand stimulation o immunity occurs 1–2 weeks ater vaccina-tion. I the interval between administration o any o these vac-cines and subsequent administration o an antibody-containingproduct is <14 days, vaccination should be repeated ater therecommended interval (Tables 4 and 5) unless serologic testingindicates a protective antibody response.

A humanized mouse monoclonal antibody product (palivi-zumab) is available as prophylaxis or serious lower respiratorytract disease rom respiratory syncytial virus among inants andyoung children. This product contains only antibody to respi-

ratory syncytial virus and does not interere with the immuneresponse to licensed live or inactivated vaccines.

Inactivated Vaccines

Antibody-containing products interact less with inactivatedvaccines, toxoids, recombinant subunit, and polysaccharidevaccines than with live vaccines (61). Thereore, administeringinactivated vaccines and toxoids either simultaneously with orat any interval beore or ater receipt o an antibody-containingproduct should not substantially impair development o aprotective antibody response (Table 4). The vaccine or toxoidand antibody preparation should be administered at dierent

sites using the standard recommended dose. Increasing thevaccine dose volume or number o vaccinations is not indicatedor recommended.

Interchangeability of Single-ComponentVaccines from Different Manufacturers

Certain vaccines that provide protection rom the samediseases are available rom dierent manuacturers, and these

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vaccines usually are not identical in antigen content or inamount or method o ormulation. Manuacturers use dier-ent production processes, and their products might containdierent concentrations o antigen per dose or a dierentstabilizer or preservative.

Available data indicate that inants who receive sequential

doses o dierent Hib conjugate, hepatitis B, and hepatitis A vaccines produce a satisactory antibody response ater acomplete primary series (62–65 ). All brands o Hib conju-gate, hepatitis B,¶ hepatitis A, rotavirus,** and quadrivalentmeningococcal conjugate vaccines are interchangeable withintheir respective series. I dierent brands o a particular vaccinerequire a dierent number o doses or series completion (e.g.,Hib and rotavirus vaccines) and a provider mixes brands, thehigher number o doses is recommended or series completion(e.g., 3 doses o either rotavirus or Hib vaccines).

Limited data are available about the saety, immunogenicity,and eicacy o using acellular pertussis (e.g., DTaP) vaccinesrom dierent manuacturers or successive doses o the per-tussis series. Data rom one study indicate that or the irst 3doses o the DTaP series, 1–2 doses o Tripedia (Sanoi Pasteur)ollowed by Inanrix (GlaxoSmithKline) or the remaining dose(or doses) is comparable to 3 doses o Tripedia with regard toimmunogenicity, as measured by antibodies to diphtheria,tetanus, and pertussis toxoids, and ilamentous hemagglutinin(66 ). However, in the absence o a clear serologic correlate o protection or pertussis, the relevance o these immunogenic-ity data or protection against pertussis is unknown. Wheneasible, the same brand o DTaP vaccine should be used or

all doses o the vaccination series. I vaccination providers donot know or have available the type o DTaP vaccine previ-ously administered to a child, any DTaP vaccine may be usedto continue or complete the series. For a child who needs 2doses o inluenza vaccine (TIV or LAIV), it is preerable touse the same type o vaccine or both doses. However, i thechild is eligible or either TIV or LAIV, and the type o vaccineused or the irst dose is not available, either vaccine can beused or the second dose. For vaccines in general, vaccinationshould not be deerred because the brand used or previousdoses is not available or is unknown ( 23,67 ).

Lapsed Vaccination ScheduleVaccination providers should administer vaccines as close

to the recommended intervals as possible. However, intervalsbetween doses that are longer than recommended typically do

not reduce inal antibody concentrations, although protectionmight not be attained until the recommended number o doseshas been administered. With exception o oral typhoid vaccinean interruption in the vaccination schedule does not requirerestarting the entire series o a vaccine or toxoid or additiono extra doses.

Unknown or Uncertain Vaccination StatusVaccination providers requently encounter persons who do

not have adequate documentation o vaccinations. With theexception o inluenza vaccine and PPSV, providers shouldonly accept written, dated records as evidence o vaccinationsel-reported doses o inluenza vaccine and PPSV are accept-able (49,68 ). Although vaccinations should not be postponedi records cannot be ound, an attempt to locate missing recordsshould be made by contacting previous health-care providersreviewing state or local IISs, and searching or a personally held

record. I records cannot be located within a reasonable timethese persons should be considered susceptible and started onthe age-appropriate vaccination schedule. Serologic testing orimmunity is an alternative to vaccination or certain antigens(e.g., measles, rubella, hepatitis A, and tetanus). Howevercommercial serologic testing might not always be suicientlysensitive or standardized or detection o vaccine-inducedimmunity (with the exception o hepatitis B vaccination at 1–2months ater the inal dose), and research laboratory testingmight not be readily available.

Contraindications and PrecautionsContraindications and precautions to vaccination are con

ditions under which vaccines should not or likely should notbe administered. Because the majority o contraindicationsand precautions are temporary, vaccinations oten can beadministered later i one or more exist. A contraindication isa condition in a recipient that increases the risk or a seriousadverse reaction. A vaccine should not be administered whena contraindication is present; or example, MMR vaccineshould not be administered to severely immunocompromisedpersons. In contrast, certain conditions are commonly mis-

perceived as contraindications (i.e., are not valid reasons todeer vaccination).

National standards or pediatric vaccination practices havebeen established and include descriptions o valid contraindica-tions and precautions to vaccination. Persons who administervaccines should screen patients or contraindications andprecautions to the vaccine beore each dose o vaccine isadministered (Table 6). Screening is acilitated by consistentuse o screening questionnaires, which are available rom certain

¶ The exception is the 2-dose hepatitis B vaccination series or adolescents aged11–15 years. Only Recombivax HB (Merck Vaccine Division) should be usedin this schedule. Engerix-B (GlaxoSmithKline) is not approved by FDA orthis schedule.

** Based on expert opinion.

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state vaccination programs and other sources (e.g., theImmunization Action Coalition, http://www.immunize.org).

The only contraindication applicable to all vaccines is ahistory o a severe allergic reaction (i.e., anaphylaxis) ater aprevious dose o vaccine or to a vaccine component (unless therecipient has been desensitized; see Special Situations section).

In addition, severely immunocompromised persons generally should not receive live vaccines. Children who experiencedencephalopathy within 7 days ater administration o a pre-vious dose o diphtheria and tetanus toxoids and whole-cellpertussis vaccine (DTP), DTaP, or Tdap not attributable toanother identiiable cause should not receive additional doseso a vaccine that contains pertussis. Because o the theoreti-cal risk to the etus, women known to be pregnant generally should not receive live, attenuated virus vaccines (see SpecialSituations section).

A precaution is a condition in a recipient that might increasethe risk or a serious adverse reaction or that might compromisethe ability o the vaccine to produce immunity (e.g., admin-istering measles vaccine to a person with passive immunity tomeasles rom a blood transusion or administering inluenzavaccine to someone with a history o Guillain-Barré syndrome within 6 weeks o a previous inluenza vaccination). A personmight experience a more severe reaction to the vaccine than would have otherwise been expected; however, the risk or thishappening is less than the risk expected with a contraindication.In general, vaccinations should be deerred when a precautionis present. However, a vaccination might be indicated in thepresence o a precaution i the beneit o protection rom the

vaccine outweighs the risk or an adverse reaction. For examplea dose o DTaP should be considered or a person in a com-munity with a pertussis outbreak even i that person previously developed Guillain-Barré syndrome ater a dose.

The presence o a moderate or severe acute illness with or without a ever is a precaution to administration o all vaccines(Table 6). A personal or amily history o seizures is a precautionor MMRV vaccination. A recent study ound an increased risk or ebrile seizures in children who receive MMRV compared with MMR and varicella vaccine ( 35 ).

Clinicians or other health-care providers might misperceivecertain conditions or circumstances as valid contraindications or

precautions to vaccination when they actually do not precludevaccination (Table 7). These misperceptions result in missedopportunities to administer recommended vaccines (69 ). Amongthe most common conditions mistakenly considered to be con-traindications are diarrhea, minor upper respiratory tract illnesses(including otitis media) with or without ever, mild to moderatelocal reactions to a previous dose o vaccine, current antimicrobialtherapy, and being in the convalescent phase o an acute illness.

The decision to administer or delay vaccination becauseo a current or recent acute illness depends on the severityo symptoms and etiology o the condition. The saety andeicacy o vaccinating persons who have mild illnesses havebeen documented (70–73). Vaccination should not be delayedbecause o the presence o mild respiratory tract illness or

other acute illness with or without ever. Vaccination shouldbe deerred or persons with a moderate or severe acute illnessThis precaution avoids causing diagnostic conusion betweenmaniestations o the underlying illness and possible adverseeects o vaccination or superimposing adverse eects o thevaccine on the underlying illness. Ater screening them orcontraindications, persons with moderate or severe acuteillness should be vaccinated as soon as the acute illness hasimproved. Studies indicate that ailure to vaccinate children with minor illnesses can impede vaccination eorts (74–76 ) Among persons whose compliance with medical care cannotbe ensured, use o every opportunity to administer appropriatevaccines is critical.

Routine physical examinations and procedures (e.g., measur-ing temperatures) are not prerequisites or vaccinating persons who appear to be healthy. The provider should ask the parentor guardian i the child is ill. I the child has a moderate orsevere illness, the vaccination should be postponed.

Preventing and ManagingAdverse Reactions

Benefit and Risk CommunicationParents, guardians, legal representatives, and adolescent and

adult patients should be inormed about the beneits o andrisks rom vaccines in language that is culturally sensitive andat an appropriate educational level. Opportunity or questionsshould be provided beore each vaccination. Discussion o thebeneits o and risks rom vaccination is sound medical practiceand is required by law.

The National Childhood Vaccine Injury Act o 1986††

requires that vaccine inormation materials be developed oreach vaccine covered by the act. These materials, known asvaccine inormation statements (VISs), must be provided byall public and private vaccination providers each time a vaccineis administered. Copies o VISs are available rom state healthauthorities responsible or vaccination and rom CDC (http:/ www.cdc.gov/vaccines). Translations o VISs into languagesother than English are available rom certain state vaccinationprograms and rom the Immunization Action Coalition website

†† National Childhood Vaccine Injury Act o 1986. 42 U.S.C. Sect. 300aa-26(1986).

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(http://www.immunize.org ). The act does not require that asignature be obtained; however, documentation o consentmight be recommended or required by certain state or localhealth authorities or school authorities.

Certain parents or patients question the need or or saety o vaccinations and want to discuss the risks rom and beneits

o certain vaccines. Some reuse certain vaccines or reject allvaccinations or personal or religious reasons. Having a basicunderstanding o how patients and parents o patients view vac-cine risk and developing eective approaches to address vaccinesaety concerns are imperative or vaccination providers.

Each person understands and reacts to vaccine inormationon the basis o dierent actors, including previous experience,education, personal values, method o data presentation, per-ceptions o the risk or disease and perceived ability to controlthese risks, and risk preerence. Increasingly, decisions aboutvaccination are based on inaccurate inormation about risk provided by the media and certain websites. Websites andother sources o vaccine inormation might be inaccurate orincomplete. Health-care providers can be a pivotal source o science-based credible inormation by discussing with parentsand patients the risks rom and beneits o vaccines, whichhelps patients make inormed decisions.

When a parent or patient initiates a discussion about a per-ceived vaccine adverse reaction, the health-care provider shoulddiscuss the speciic concerns and provide actual inormation,using appropriate language. Eective, empathetic vaccine risk communication is essential in responding to misinormationand concerns, with health-care providers recognizing that risk

assessment and decision-making can be diicult and conusing.Certain vaccines might be acceptable to a parent who is resistantto other vaccines. This partial acceptance can be used to acilitateadditional communication. Their concerns can be addressed usingthe VIS and oering other resource materials (e.g., vaccinationinormation rom CDC: http://www.cdc.gov/vaccines).

The American Academy o Pediatrics (AAP) does not rec-ommend that providers exclude rom their practice patients whose parents or guardians question or reuse vaccination. A limited number o providers might exclude patients on thisbasis; however, an eective public health strategy is to identiy common ground and discuss measures that need to be ollowed

i the decision is to deer vaccination. Health-care providersshould reinorce key points about each vaccine, includingsaety, and emphasize risks or disease among unvaccinatedchildren. Parents should be advised o state laws regardingentry to schools or child-care acilities, which might requirethat unvaccinated children be excluded rom the acility dur-ing outbreaks. These discussions should be documented in thepatient’s medical record, including the reusal to receive certainvaccines (i.e., inormed reusal).

Preventing Adverse ReactionsVaccines are intended to produce active immunity to spe-

ciic antigens. An adverse reaction is an undesirable side eecthat occurs ater a vaccination. Vaccine adverse reactions areclassiied as 1) local, 2) systemic, or 3) allergic (additional

inormation available at http://www.da.gov ). Local reactions(e.g., redness) are usually the least severe and most requentSystemic reactions (e.g., ever) occur less requently than locareactions, and severe allergic reactions (e.g., anaphylaxis) are theleast requent reactions. Severe adverse reactions are rare.

Syncope (vasovagal or vasodepressor reaction) can occurater vaccination and is most common among adolescents andyoung adults. In 2005, the Vaccine Adverse Event ReportingSystem (VAERS) began detecting a trend o increasing syncopereports that coincided with the licensure o three vaccines oradolescents: human papillomavirus (HPV), MCV4, and Tdap(77 ). O particular concern among adolescents has been the

risk or serious secondary injuries, including skull racture andcerebral hemorrhage. O 463 VAERS reports o syncope during January 1, 2005, to July 31, 2007, a total o 41 listed syncope with secondary injury with inormation on the timing atervaccination, and the majority o these syncope reports (76%)occurred among adolescents. Among all age groups, 80% oreported syncope episodes occur within 15 minutes o vaccineadministration (additional inormation available at http:/ www.cdc.gov/vaccinesaety/concern/syncope.htm). Providersshould take appropriate measures to prevent injuries i a patientbecomes weak or dizzy or loses consciousness. Adolescentsand adults should be seated or lying down during vaccination

Vaccine providers, particularly when vaccinating adolescentsshould consider observing patients (with patients seated orlying down) or 15 minutes ater vaccination to decrease therisk or injury should they aint (77 ). I syncope developspatients should be observed until the symptoms resolve.

Managing Acute Vaccine Reactions Although anaphylactic reactions are rare ater vaccination

their immediate onset and lie-threatening nature require thaall personnel and acilities providing vaccinations have procedures in place or anaphylaxis management. All vaccination

providers should be amiliar with the oice emergency planand be currently certiied in cardiopulmonary resuscitationEpinephrine and equipment or maintaining an airway shouldbe available or immediate use.

Anaphylaxis usually begins within minutes o vaccinadministration (78–80 ). Rapid recognition and initiation otreatment are required to prevent possible progression to car-diovascular collapse. I lushing, acial edema, urticaria, itchingswelling o the mouth or throat, wheezing, dyspnea, or other



http://www.fda.gov/

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signs or symptoms o anaphylaxis occur, the patient should beplaced in a recumbent position with the legs elevated i possible(81,82 ). Administration o epinephrine is the management o choice. Additional drugs also might be indicated (Table 8) (83).Maintenance o the airway and oxygen administration might benecessary. Ater the patient is stabilized, arrangements should

be made or immediate transer to an emergency acility oradditional evaluation and treatment.

Reporting Adverse EventsAfter Vaccination

Modern vaccines are sae and eective; however, adverseevents have been reported ater administration o all vaccines(84 ). More complete inormation about adverse reactions to aspeciic vaccine is available in the package insert or each vac-cine and rom CDC at http://www.cdc.gov/vaccines/vac-gen/side-eects.htm. An adverse event is an untoward event that

occurs ater a vaccination that might be caused by the vaccineproduct or vaccination process. These events range rom com-mon, minor, local reactions to rare, severe, allergic reactions(e.g., anaphylaxis). Establishing evidence or cause and eecton the basis o case reports and case series alone is usually not possible because health problems that have a temporal associa-tion with vaccination do not necessarily indicate causality.

Many adverse events require more detailed epidemiologicstudies to compare the incidence o the event among vaccineesto the incidence among unvaccinated persons. Reportingadverse events, including serious events, to VAERS is a key mechanism or identiying potential vaccine saety concerns.Potential causal associations between reported adverse eventsater vaccination can be assessed through epidemiologic orclinical studies.

The National Childhood Vaccine Injury Act requireshealth-care providers and vaccine manuacturers to report toVAERS speciic adverse events that occur ater vaccination.The reporting requirements are dierent or manuacturers andhealth-care providers. Manuacturers are required to report alladverse events that occur ater vaccination to VAERS, whereashealth-care providers are required to report events that appearin the reportable events table on the VAERS website at http://

vaers.hhs.gov/reportable.htm.In addition to the mandated reporting o events listed onthe reportable events table, health-care providers should reportto VAERS all events listed in product inserts as contraindica-tions, as well as all clinically signiicant adverse events, even i they are uncertain that the adverse event is related causally tovaccination. Persons other than health-care providers also canreport adverse events to VAERS.

There are three ways to report to VAERS:1. Submit the report online via a secure website at https://

vaers.hhs.gov/esub/step1,2. Fax a completed VAERS orm to 877-721-0366, or3. Mail a completed VAERS orm: VAERS, P.O. Box 1100

Rockville, MD 20849-1100.

A VAERS orm can be downloaded rom the VAERS web-site at http://vaers.hhs.gov/resources/vaers_orm.pd . VAERSorms also can be requested by e-mail ([email protected]), tele-phone (800-822-7967), or ax (877-721-0366).

National Vaccine InjuryCompensation Program

The National Vaccine Injury Compensation Programestablished by the National Childhood Vaccine Injury Act o1986, is a no-ault system in which persons thought to haveexperienced an injury or to have died as a result o administra-

tion o a covered vaccine can seek compensation. The programbecame operational on October 1, 1988, and is intended as analternative to civil litigation under the traditional tort systemin that negligence need not be proven. Claims arising romcovered vaccines must irst be adjudicated through the programbeore civil litigation can be pursued.

The program relies on the Vaccine Injury Table, which liststhe vaccines covered by the program and the injuries (includingdeath), disabilities, illnesses, and conditions or which com-pensation might be awarded. The table deines the time during which the irst symptom or substantial aggravation o an injurymust appear ater vaccination to be eligible. Successul claim-ants receive a legal presumption o causation i a condition listedin the table is proven, thus avoiding the need to prove actuacausation in an individual case. Claimants also can prevail orconditions not listed in the reportable events table i they provecausation or covered vaccines. Additional inormation is avail-able rom the Health Resources and Services Administration(HRSA) (http://www.hrsa.gov/vaccinecompensation, tele-phone: 800-338-2382). Persons who would like to ile a claimor vaccine injury should contact the U.S. Court o FederaClaims (717 Madison Place, N.W., Washington, DC 20005telephone: 202-357-6400).

Vaccine Administration

Infection Control and Sterile Technique

General Precautions

Persons administering vaccinations should ollow appropri-ate precautions to minimize risk or spread o disease. Hands

http://www.cdc.gov/vaccines/vac-gen/side-effects.htm


http://vaers.hhs.gov/reportable.htm


https://vaers.hhs.gov/esub/step1


http://vaers.hhs.gov/resources/vaers_form.pdf


http://www.hrsa.gov/vaccinecompensation

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should be cleansed with an alcohol-based waterless antiseptichand rub or washed with soap and water beore preparing thevaccine and between each patient contact (85 ). OccupationalSaety and Health Administration (OSHA) regulations do notrequire gloves to be worn when administering vaccinations,unless persons administering vaccinations are likely to come

into contact with potentially inectious body luids or haveopen lesions on their hands. I gloves are worn, they shouldbe changed between patients.

Needles and Syringes

Needles and syringes used or vaccine injections must besterile and disposable. A separate needle and syringe shouldbe used or each injection. Changing needles between draw-ing vaccine rom a vial and injecting it into a recipient is notnecessary unless the needle has been damaged or contami-nated. Dierent vaccines should never be mixed in the samesyringe unless speciically licensed or such use, and no attempt

should be made to transer between syringes. Single-dose vialsand manuacturer-illed syringes are designed or single-doseadministration and should be discarded i vaccine has been withdrawn or reconstituted and subsequently not used withinthe time rame speciied by the manuacturer. This typically isno longer than the same clinic day (typically recommended asa maximum or inactivated vaccines).

Sometimes providers preill syringes themselves. ACIP dis-courages the routine practice o preilling syringes because o the potential or administration errors and vaccine wastage.Because the majority o vaccines have a similar appearance ater

being drawn into a syringe, preilling might result in adminis-tration errors. In certain circumstances in which a single vac-cine type is being used (e.g., in preparation or a community inluenza vaccination campaign), illing a small number o syringes may be considered. Vaccine doses should not be drawninto a syringe until immediately beore administration. Whensyringes are illed, the type o vaccine, lot number, and date o illing must be labeled on each syringe, and the doses should beadministered as soon as possible ater illing. Unused syringesilled by the end user (i.e., not illed by the manuacturer)should be discarded at the end o the vaccination session. Inaddition to administration errors, preilling o syringes is a

concern because FDA does not license administration syringesor vaccine storage. Unused syringes that are preilled by themanuacturer and activated (i.e., syringe cap removed or needleattached) should be discarded at the end o the clinic day. When in doubt about the appropriate handling o a vaccine,vaccination providers should contact the manuacturer.

Bloodborne diseases (e.g., hepatitis B, hepatitis C, andhuman immunodeiciency virus [HIV]) are occupationalhazards or clinicians and other health-care providers. The

Needlestick Saety and Prevention Act was enacted in 2000to reduce the incidence o needle-stick injury and the con-sequent risk or bloodborne diseases acquired rom patientsThe act directed OSHA to strengthen its existing bloodbornepathogen standards. The revised standards became eectivein 2001 (86 ). These ederal regulations require that saety-

engineered injection devices (e.g., needle-shielding syringesor needle-ree injectors) be used or injectable vaccination inall clinical settings. The regulations also require maintenanceo records documenting injuries caused by needles and othermedical sharp objects and that nonmanagerial employees beinvolved in the evaluation and selection o saety-engineereddevices beore they are procured.

Saety-engineered needles and syringes or needle-ree injection devices are preerred and should be encouraged to reducerisk or injury. To prevent inadvertent needle-stick injury orreuse, saety mechanisms should be deployed ater use andneedles and syringes should be discarded immediately inlabeled, puncture-proo containers located in the same room where the vaccine is administered. Used needles should neverbe recapped.

Needle-shielding or needle-ree devices that might satisythe occupational saety regulations or administering injectablevaccines are available in the United States (87–89 ). Additionainormation about implementation and enorcement o theseregulations is available rom OSHA (http://www.osha.gov ).

Route of Administration

Oral RouteRotavirus and oral typhoid vaccines are the only vaccines

administered orally in the United States. Oral typhoid capsulesshould be administered as directed by the manuacturer. Thecapsules should not be opened or mixed with any other sub-stance. Rotavirus vaccines are licensed or inants. There aretwo brands o rotavirus vaccine, and they have dierent typeso applicators. Providers should consult the package insert ordetails. A dose o rotavirus vaccine need not be repeated i thevaccine is spit up or vomited. The inant should receive theremaining recommended doses o rotavirus vaccine ollowingthe routine schedule.

Intranasal Route

LAIV is licensed or healthy nonpregnant persons aged 2–49years and is the only vaccine administered by the intranasal routeThe administration device is a nasal sprayer with a dose-dividerclip that allows introduction o one 0.1-mL spray into each narisThe tip should be inserted slightly into the naris beore admin-istration. Even i the person coughs or sneezes immediately ateradministration or the dose is expelled any other way, the vaccine

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dose need not be repeated. Introduction o low levels o vaccineviruses into the environment likely is unavoidable when adminis-tering LAIV; however, no instances have been reported o illness orattenuated vaccine virus inections among inadvertently exposedhealth-care providers or immunocompromised patients. The risk or acquiring vaccine viruses rom the environment is unknown

but is likely low; in addition, vaccine viruses are cold-adaptedand attenuated and unlikely to cause symptomatic inluenza.Severely immunosuppressed persons should not administer LAIV.However, other persons at higher risk or inluenza complicationscan administer LAIV. These include persons with underlyingmedical conditions placing them at higher risk or who are likely to be at risk, including pregnant women, persons with asthma,and persons aged ≥50 years (68 ).

Injectable Route

With the exception o bacille Calmette-Guérin (BCG) vac-cine and smallpox vaccine, injectable vaccines are administered

by the intramuscular or subcutaneous route. The method o administration o injectable vaccines is determined, in part,by the presence o adjuvants in some vaccines. An adjuvant isa vaccine component distinct rom the antigen that enhancesthe immune response to the antigen. Inactivated vaccinescontaining an adjuvant should be injected into a musclebecause administration subcutaneously or intradermally cancause local irritation, induration, skin discoloration, inlamma-tion, and granuloma ormation. Routes o administration arerecommended by the manuacturer or each immunobiologic(Table 9). Deviation rom the recommended route o admin-

istration might reduce vaccine eicacy (90,91) or increase therisk or local adverse reactions (92–94 ).

Intramuscular Injections

Needle Length

Injectable immunobiologics should be administered wherelocal, neural, vascular, or tissue injury is unlikely. Use o longerneedles has been associated with less redness or swelling thanoccurs with shorter needles because o injection into deepermuscle mass (92 ). Appropriate needle length depends on ageand body mass. Injection technique is the most importantparameter to ensure eicient intramuscular vaccine delivery.

For all intramuscular injections, the needle should belong enough to reach the muscle mass and prevent vaccinerom seeping into subcutaneous tissue, but not so long as toinvolve underlying nerves, blood vessels, or bone (91,95–97 ).Vaccinators should be amiliar with the anatomy o the areainto which they are injecting vaccine. Intramuscular injectionsare administered at a 90-degree angle to the skin, preer-ably into the anterolateral aspect o the thigh or the deltoid

muscle o the upper arm, depending on the age o the patient(Table 10).

A decision on needle size and site o injection must be madeor each person on the basis o the size o the muscle, thethickness o adipose tissue at the injection site, the volume othe material to be administered, injection technique, and the

depth below the muscle surace into which the material is to beinjected (Figure 1). Aspiration beore injection o vaccines ortoxoids (i.e., pulling back on the syringe plunger ater needleinsertion but beore injection) is not necessary because no largeblood vessels are present at the recommended injection sitesand a process that includes aspiration might be more painuor inants (98 ).

Infants (Aged <12 Months)

For the majority o inants, the anterolateral aspect o thethigh is the recommended site or injection because it providea large muscle mass (Figure 2). In certain circumstances (e.g.

physical obstruction to other sites and no reasonable indicationto deer doses), the gluteal muscle can be used. I the glutealmuscle must be used, care should be taken to deine the ana-tomic landmarks.§§ Injection technique is the most importantparameter to ensure eicient intramuscular vaccine delivery. Ithe subcutaneous and muscle tissue are bunched to minimizethe chance o striking bone (95 ), a 1-inch needle is required toensure intramuscular administration in inants aged ≥1 monthFor the majority o inants, a 1-inch, 22- to 25-gauge needleis suicient to penetrate the thigh muscle. For neonates (irs28 days o lie) and preterm inants, a ⅝-inch needle usuallyis adequate i the skin is stretched lat between the thumb andoreinger and the needle is inserted at a 90-degree angle tothe skin (97 ).

Toddlers (Aged 12 Months–2 Years)

For toddlers, the anterolateral thigh muscle is preerred, andi used, the needle should be at least 1 inch long. The deltoidmuscle can be used i the muscle mass is adequate. A ⅝-inchneedle is adequate only or the deltoid muscle and only i theskin is stretched lat between thumb and oreinger and theneedle is inserted at a 90-degree angle to the skin.

Children (Aged 3–18 Years)

The deltoid muscle is preerred or children aged 3–18 year(Figure 3); the needle size or deltoid site injections can rangerom 22 to 25 gauge and rom ⅝ to 1 inch on the basis o tech-nique. Knowledge o body mass can be useul or estimating

§§ I the gluteal muscle is chosen, injection should be administered lateral andsuperior to a line between the posterior superior iliac spine and the greatetrochanter or in the ventrogluteal site, the center o a triangle bounded by thanterior superior iliac spine, the tubercle o the iliac crest, and the upper bordeo the greater trochanter.

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the appropriate needle length (99 ); however, neither a physicalexamination nor measurement o body mass is necessary toadminister vaccines. Most children in this age range require a⅝- or 1-inch needle (or intermediate size, i available).

Adults (Aged ≥19 Years)

For adults, the deltoid muscle is recommended or routineintramuscular vaccinations. The anterolateral thigh also canbe used. For men and women who weigh <130 lbs (<60 kg),a ⅝-inch needle is suicient to ensure intramuscular injectionin the deltoid muscle i the injection is made at a 90-degreeangle and the tissue is not bunched. For men and women who weigh 130–152 lbs (60–70 kg), a 1-inch needle is suicient.For women who weigh 152–200 lbs (70–90 kg) and men who weigh 152–260 lbs (70–118 kg), a 1- to 1½ -inch needleis recommended. For women who weigh >200 lbs (>90 kg)or men who weigh >260 lbs (>118 kg), a 1½-inch needle isrecommended (Table 10) (96 ).

Subcutaneous Injections

Subcutaneous injections are administered at a 45-degreeangle, usually into the thigh or inants aged <12 months andin the upper-outer triceps area o persons aged ≥12 months.Subcutaneous injections may be administered into the upper-outer triceps area o an inant i necessary. A ⅝-inch, 23- to25-gauge needle should be inserted into the subcutaneoustissue (Figures 4 and 5).

Multiple Injections

I multiple vaccines are administered at a single visit, admin-

ister each preparation at a dierent anatomic site. For inantsand younger children, i more than two vaccines are injectedin a single limb, the thigh is the preerred site because o thegreater muscle mass; the injections should be suiciently sepa-rated (i.e., ≥1 inch i possible) so that any local reactions canbe dierentiated (92,100 ). For older children and adults, thedeltoid muscle can be used or more than one intramuscularinjection. I a vaccine and an immune globulin preparationare administered simultaneously (e.g., Td/Tdap and tetanusimmune globulin [TIG], hepatitis B and hepatitis B immuno-globulin [HBIG]), separate anatomic sites (i.e., dierent limbs)

should be used or each injection. The location o all injectionsites should be documented in the patient’s medical record.Health-care practices should consider using a vaccination sitemap so that all persons administering vaccines routinely use aparticular anatomic site or each dierent vaccine.

Jet Injections

Jet injectors are needle-ree devices that pressurize liquidmedication, orcing it through a nozzle oriice into a narrow

stream capable o penetrating skin to deliver a drug or vac-cine into intradermal, subcutaneous, or intramuscular tissue(101,102 ). Jet injectors prevent needle-stick injuries to health-care providers (86 ) and can overcome improper, unsterile reuseand other drawbacks o needles and syringes in developingcountries (87,103–104 ). Immune responses generated by jet

injectors against both attenuated and inactivated viral andbacterial antigens are usually equivalent to, and occasionallygreater than, immune responses induced by needle injectionHowever, local reactions or injuries are sometimes more re-quent on delivery o vaccine by jet injectors compared withneedle injection, depending on the inherent irritability o thevaccine and operator technique (102 ). Jet injectors that usethe same nozzle or consecutive injections without interveningsterilization were used in mass vaccination campaigns rom the1950s through the 1990s (102 ); however, these were ound tobe unsae because o the possibility o bloodborne pathogentransmission (105–108 ) and should not be used. A new gen-eration o jet injectors with disposable cartridges and syringeshas been developed since the 1990s. With a new, sterile dosechamber and nozzle or each patient and correct use, thesedevices do not have the same saety concerns as multiple-usenozzle jet injectors. Several o the newer devices have beenapproved by FDA or sale in the United States (102 ).

Methods for Alleviating Discomfortand Pain Associated with Vaccination

Comort measures, such as distraction (e.g., playing musicor pretending to blow away the pain), ingestion o sweetliquids, breasteeding, cooling o the injection site, and topi-cal analgesia, can help inants or children cope with the dis-comort associated with vaccination (109,110 ). Pretreatmen(30–60 minutes beore injection) with a 5% topical lidocaine-prilocaine emulsion might decrease the pain o vaccination bycausing supericial anesthesia (111,112 ). Evidence indicatesthat this cream does not interere with the immune responseto MMR (113). Topical lidocaine-prilocaine emulsion shouldnot be used on inants aged <12 months who are receivingtreatment with methemoglobin-inducing agents because othe possible development o methemoglobinemia (114 ). Use

o a topical rerigerant (vapocoolant) spray immediately beorevaccination can reduce the short-term pain associated withinjections and can be as eective as lidocaine-prilocaine cream(115 ). Evidence does not support use o antipyretics beore oat the time o vaccination; however, they can be used or thetreatment o ever and local discomort that might occur ollowing vaccination. Studies o children with previous ebrileseizures have not demonstrated antipyretics to be eective inthe prevention o ebrile seizures (116 ).

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Nonstandard Vaccination PracticesRecommendations or route, site, and dosage o immunobiolog-

ics are derived rom data rom clinical trials, practical experience,normal periodicity o health-care visits, and theoretical consider-ations. ACIP discourages variations rom the recommended route,

site, volume, or number o doses o any vaccine.Variation rom the recommended route and site can result ininadequate protection. In adults (but not in inants) (117 ), theimmunogenicity o hepatitis B is substantially lower when thegluteal rather than the deltoid site is used or administration(90 ). Hepatitis B administered intradermally might result in alower seroconversion rate and inal titer o hepatitis B suraceantibody than when administered by the deltoid intramuscularroute (118,119 ). Hepatitis B administered by any route otherthan intramuscular, or in adults at any site other than the deltoidor anterolateral thigh, should not be counted as valid and shouldbe repeated. Similarly, doses o rabies vaccine administered in

the gluteal site should not be counted as valid doses and shouldbe repeated (120 ). MCV4 should be administered intramuscu-larly; however, revaccination is not necessary i a vaccine dose isadministered subcutaneously (121). Inactivated inluenza vaccineis immunogenic when administered in a lower than standarddose by the intradermal route to healthy adult volunteers (122 ).However, the immunogenicity or persons aged ≥60 years isinadequate, and varying the recommended route and dose is notrecommended.

Live, attenuated injectable vaccines (e.g., MMR, varicella, andyellow ever) and certain inactivated vaccines (e.g., meningococ-cal polysaccharide) are recommended by the manuacturers to

be administered by subcutaneous injection. PPSV and IPV arerecommended by the manuacturer to be administered by thesubcutaneous or intramuscular route. Response to vaccines rec-ommended by the subcutaneous route are unlikely to be aectedi the vaccines are administered by the intramuscular rather thansubcutaneous route. Repeating doses o vaccine administeredby the intramuscular route when recommended to be by thesubcutaneous route is not necessary.

Administering volumes smaller than recommended (e.g., inap-propriately divided doses) might result in inadequate protection.Using reduced doses administered at multiple vaccination visitsthat equal a ull dose or using smaller divided doses is not recom-mended. Any vaccination using less than the standard dose shouldnot be counted, and the person should be revaccinated accordingto age unless serologic testing indicates that an adequate responsehas developed. I less than a ull recommended dose o a parenteralvaccine is administered because o syringe or needle leakage, thedose should be repeated. Using larger than recommended dosagescan be hazardous because o excessive local or systemic concentra-tions o antigens or other vaccine constituents.

Storage and Handlingof Immunobiologics

Failure to adhere to recommended speciications or storageand handling o immunobiologics can reduce or destroy theirpotency, resulting in inadequate or no immune response in the

recipient. Recommendations in the product package insertsincluding methods or reconstitution o the vaccine, should beollowed careully. Maintenance o vaccine quality is the sharedresponsibility o all handlers o vaccines rom the time a vaccineis manuactured until administration. All vaccines should beinspected on delivery and monitored during storage to ensurethat the recommended storage temperatures are maintainedVaccines should continue to be stored at recommended tem-peratures immediately on receipt until use. Inadequate vaccinestorage also can result in the loss o thousands o dollars wortho vaccine inventory and the cost o inventory replacement.

Storage TemperatureVaccines licensed or rerigerator storage should be stored at

35°F–46°F (2°C–8°C). Liquid vaccines containing an alumi-num adjuvant permanently lose potency when exposed to reez-ing temperatures. Live, attenuated virus vaccines that shouldbe rozen lose potency when exposed to higher temperaturesbecause the viruses degrade more quickly at storage temperatures that are warmer than recommended (Table 11).

Storage Units

Rerigerators and reezers used or vaccine storage musmaintain the required temperature range year-round, be largeenough to hold the year’s largest inventory, and be dedicatedto storage o vaccines. Vaccine storage units must be careullyselected, used properly, and consistently monitored to ensurethat recommended temperatures are maintained. Rerigerator without reezers and stand-alone reezers (either manual derostor automatic derost) are usually the most eective at maintain-ing the precise temperatures required or vaccine storage. Suchsingle-purpose units sold or home use are less expensive alter-natives to medical specialty equipment (123) and are preerableto combination units. A combination rerigerator-reezer uni

sold or home use might be adequate or storing limited quan-tities o vaccines i the rerigerator and reezer compartmenthave separate external doors. Beore using the rerigerator orvaccine storage, the temperature should be allowed to stabilizeand then be measured in various locations within the rerigera-tor compartment to document that a consistent temperaturecan be maintained within the compartment (Table 11) (124 )New units might need ≥2 days o operation to establish a stableoperating temperature; vaccine should not be stored in the unit

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until the unit maintains an appropriate and stable storage tem-perature. Rerigerator temperatures are most relective o theactual compartment temperature ater the door has remainedclosed and undisturbed or several hours (e.g., overnight).The rerigerator temperature should be set at the midpointo the recommended range (i.e., 40°F [5°C]) (125,126 ). A

storage unit should be suiciently sized so that vaccines canbe placed away rom the walls in the part o the unit best ableto maintain the constant, required temperature. Combinationunits, with separate compartments o smaller size, can only beused to store limited quantities o vaccines. Frequent openingand closing o doors can cause luctuations in compartmenttemperature; ood, beverages, and clinical specimens shouldnot be stored in vaccine storage units. I it becomes necessary to store clinical specimens in the same unit as vaccines, theclinical specimens should be on a shel below the vaccine toprevent contamination should the specimen leak.

Temperature MonitoringTemperature monitoring is a critical component o tempera-

ture management. All oice and clinical sta members shouldbe aware o vaccine vulnerabilities and storage requirements. Assigning one person in the oice the primary responsibility ormaintaining and reviewing temperature logs (Figure 6) gener-ally is most eective, with a second person assigned as backup.Temperatures or both the rerigerator and reezer should bedocumented twice a day and recorded. The backup personshould review the log at least once each week. Temperaturelogs should be maintained or 3 years unless state or local

authorities require a longer time. An automated monitoringsystem that alerts sta when a temperature deviation occursis optimal. However, even i an automated monitoring systemis used, temperatures still should be manually checked andrecorded twice each day.

Thermometers should be placed in each compartment nearthe vaccines. Dierent types o thermometers can be used,including standard luid-illed, minimum-maximum, andcontinuous chart recorder thermometers (Table 12). Standardluid-illed thermometers are the simplest and least expensiveproducts. Product temperature thermometers are encased inbiosae liquids and generally relect rerigerator temperaturemore accurately than standard luid-illed thermometers.Minimum-maximum thermometers monitor the temperaturerange. Continuous chart recorder thermometers monitor tem-perature range and duration. All thermometers used or moni-toring vaccine storage temperatures should be calibrated andcertiied by an appropriate agency (e.g., National Institute o Standards and Technology or the American Society or Testingand Materials). Because all thermometers are calibrated as part

o the manuacturing process, this recommendation reers toa second calibration process that occurs ater manuacturingbut beore marketing and is documented with a certiicatethat comes with the product. Some products (e.g., continuouchart recorder thermometers) usually include a manuacturerdeined schedule or additional recalibration. For many type

o thermometers, replacement might be less expensive thanrecalibration. Thermometers that require batteries need to havethe batteries changed; review the documentation that comes with the product or guidance.

Response to Out-of-RangeTemperature Reading

An out-o-range temperature reading should prompimmediate action. A plan should be developed ahead o timeto address various types o emergencies that might requireremoval o vaccine rom the original storage unit. Transer o

vaccines to a predesignated alternative emergency storage sitemight be necessary i a temperature problem cannot be resolvedimmediately (e.g., plugging in an unplugged unit or closing adoor that has been let open). Vaccine should be marked “donot use” and moved to the alternate site ater veriying thatthe alternate unit is at the proper temperature. Ater the vac-cine has been moved, determine whether the vaccine is stiluseable by contacting the state or local health department ormanuacturer. Damage to the immunogenicity o a vaccineexposed to temperatures outside o the recommended rangemight not be apparent visually. As a general rule, vaccines thahave been stored at inappropriate temperatures should notbe administered. I such vaccines already have been adminis-tered, guidance is available rom the state health departmentor CDC. Vaccine exposed to inappropriate temperatures thatis inadvertently administered should generally be repeatedClinicians should consult with state or local health depart-ments in these situations.

Expiration Dates and Windows All vaccines have an expiration date determined by the

manuacturer that must be observed. Providers should recordthe vaccine expiration dates and lot numbers on a stock orinventory record or each vaccine vial when a shipment isreceived. When vaccines are removed rom storage, clinicianand other health-care providers should note whether an expira-tion window exists or vaccine stored at room temperature or aan intermediate temperature. For example, single-componentvaricella vaccine that is stored rozen must be discarded ater72 hours o storage at rerigerator temperature. Vaccine trans-port between the storage site and the administration clinic is

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discouraged unless the cold chain is maintained, and vaccinetransport by the patient (e.g., transporting zoster vaccinerom a pharmacy to a clinic) is particularly discouraged. Anexpiration window also applies to vaccines that have beenreconstituted. For example, ater reconstitution, MMR vac-cine should be kept at rerigerator temperature and must be

administered within 8 hours. Doses o expired vaccines that areadministered inadvertently generally should not be counted asvalid and should be repeated. Inactivated vaccines should berepeated as soon as possible. Live vaccines should be repeatedater a 28-day interval rom the invalid dose to reduce therisk or intererence rom intereron on the subsequent doses. Additional inormation about expiration dates is available athttp://www.cdc.gov/vaccines/recs/storage.

Multidose VialsCertain vaccines (i.e., quadrivalent meningococcal poly-

saccharide vaccine [MPSV4], PPSV, TIV, IPV, and yellow ever) are available in multidose vials. Because several dosesare withdrawn rom the same vial, proper technique must beollowed to prevent contamination. For multidose vials thatdo not require reconstitution, doses that remain ater with-drawal o a dose can be administered until the expiration dateprinted on the vial or vaccine packaging i the vial has beenstored correctly and the vaccine is not visibly contaminated,unless otherwise speciied by the manuacturer. Multidose vialsthat require reconstitution must be used within the intervalspeciied by the manuacturer. Ater reconstitution, the new expiration date should be written on the vial.

Altered Immunocompetence

General Principles Altered immunocompetence, a term oten used synony-

mously with immunosuppression and immunocompromise,can be classiied as primary or secondary. Primary immunodei-ciencies generally are inherited and include conditions deinedby an absence or quantitative deiciency o cellular or humoralcomponents or both that provide immunity. Examples include

congenital immunodeiciency diseases such as X-linked agam-maglobulinemia, severe combined immunodeiciency disease,and chronic granulomatous disease. Secondary immunodei-ciency generally is acquired and is deined by loss or qualitativedeiciency in cellular or humoral immune components thatoccurs as a result o a disease process or its therapy. Exampleso secondary immunodeiciency include HIV inection,hematopoietic malignancies, treatment with radiation, andtreatment with immunosuppressive drugs including alkylating

agents and antimetabolites. The degree to which immunosup-pressive drugs cause clinically signiicant immunodeiciencygenerally is dose related and varies by drug. Primary and sec-ondary immunodeiciencies might include a combination odeicits in both cellular and humoral immunity. In this reportthe general term altered immunocompetence also is used to

include conditions such as asplenia and chronic renal diseaseand treatments with therapeutic monoclonal antibodies (spe-ciically, the tumor necrosis actor inhibitors) (127–132 ) andprolonged administration o high-dose corticosteroids.

Determination o altered immunocompetence is impor-tant to the vaccine provider because incidence or severity osome vaccine-preventable diseases is higher in persons withaltered immunocompetence; thereore, certain vaccines (e.g.inactivated inluenza vaccine and pneumococcal vaccines)are recommended speciically or persons with these diseases( 28,68 ). Vaccines might be less eective during the period oaltered immunocompetence. Live vaccines might need to bedeerred until immune unction has improved. Inactivatedvaccines administered during the period o altered immuno-competence might need to be repeated ater immune unctionhas improved. In addition, persons with altered immuno-competence might be at increased risk or an adverse reactionater administration o live, attenuated vaccines because ouninhibited replication.

The degree o altered immunocompetence in a patient shouldbe determined by a physician. The challenge or clinicians andother health-care providers is assessing the saety and eective-ness o vaccines or conditions associated with primary or sec-

ondary immunodeiciency, especially when new therapeuticmodalities are being used and inormation about the saety andeectiveness o vaccines has not been characterized ully inpersons receiving these drugs (Table 13). Laboratory studies canbe useul or assessing the eects o a disease or drug on theimmune system. Tests useul to assess humoral immunity includeimmunoglobulin (and immunoglobulin subset) levels and spe-ciic antibody levels (e.g., tetanus and diphtheria). Tests thatdemonstrate the status o cellular immunity include lymphocytenumbers (i.e., a complete blood count with dierential), a testhat delineates concentrations and proportions o lymphocytesubsets (i.e., B and T lymphocytes, CD4+ T versus CD8+ T

lymphocytes), and tests that measure T-cell prolieration inresponse to speciic or nonspeciic stimuli (e.g., lymphocyteprolieration assays) (133,134 ). The ability to characterize a drugor disease condition as aecting cellular or humoral immunityis only the irst step; using this inormation to draw inerencesabout whether particular vaccines are indicated or whether cau-tion is advised with use o live or inactivated vaccines is morecomplicated and might require consultation with an inectiousdisease or immunology specialist.

http://www.cdc.gov/vaccines/recs/storage

http://www.cdc.gov/vaccines/recs/storage

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Altered Immunocompetenceas an Indication to Receive a Vaccine

Persons with altered immunocompetence generally areadvised to receive TIV and age-appropriate polysaccharide-based vaccines (PCV, PPSV, MCV4, MPSV4, and Hib) on

the basis o demonstrated eectiveness or an increased risk ordisease i the vaccine is withheld.

Pneumococcal Vaccines

Two types o vaccine against invasive pneumococcal disease areavailable in the United States: PCV and PPSV. PCV is recom-mended routinely or all children beginning at age 2 months.PCV is recommended routinely up to age 59 months or healthy children and up to 71 months or children with conditions thatplace them at high risk or invasive disease rom Streptococcus pneumoniae . PPSV is licensed or persons aged ≥2 years andrecommended or persons with certain underlying medical condi-

tions (including altered immunocompetence) and or all personsaged ≥65 years. Complete recommendations on use o PCV andPPSV are available in the Recommended Immunization Schedules for Persons Aged 0 Through 18 Years and the Recommended Adult Immunization Schedule ( 25 ,49 ).

Influenza Vaccines

Two types o inluenza vaccine are used in the United States:TIV and LAIV. Vaccination with TIV is recommended specii-cally or persons with altered immunocompetence, includingHIV inection. LAIV usually is contraindicated or persons with altered immunocompetence, although healthy persons

with anatomic or unctional asplenia and household and otherclose contacts o persons with altered immunocompetence canreceive this vaccine (68 ).

Meningococcal Vaccines

Two types o meningococcal vaccine are licensed in theUnited States: MCV4 and MPSV4. Persons with asplenia,C3 complement deiciency (51), or persistent complementcomponent deiciency are at increased risk or meningococcaldisease and should receive MCV4 or MPSV4. QuadrivalentMCV4 is licensed or persons aged 2–55 years; persons aged≥56 years should receive MPSV4.

Hib Vaccines

Hib conjugate vaccines are available in single or combinedantigen preparations. Hib vaccine is recommended routinely or all children through age 59 months. However, a singledose o Hib vaccine also may be considered or asplenic older

children, adolescents, and adults who did not receive thevaccine series in childhood. Clinicians and other health-careproviders might consider use o Hib vaccine or persons withHIV inection who did not receive the vaccine during inancyor childhood.

Vaccination of Contacts of Personswith Altered Immunocompetence

Household contacts and other close contacts o persons withaltered immunocompetence may receive all age-appropriatevaccines, with the exception o smallpox vaccine. MMRvaricella, and rotavirus vaccines should be administered tosusceptible household contacts and other close contacts oimmunocompromised patients when indicated. MMR vac-cine viruses are not transmitted to contacts, and transmissiono varicella vaccine is rare ( 2,4,135 ). No speciic precautionsare needed unless the varicella vaccine recipient has a rash

ater vaccination, in which case direct contact with susceptiblehousehold contacts should be avoided until the rash resolves(4,135 ). All members o the household should wash theirhands ater changing the diaper o an inant. This minimizerotavirus transmission, or an undetermined number o weeksater vaccination, rom an inant who received rotavirus vaccine(136 ). Household and other close contacts o persons withaltered immunocompetence should receive annual inluenzavaccination. LAIV may be administered to healthy householdand other close contacts o persons with altered immunocompetence (68 ).

Vaccination with Inactivated Vaccines All inactivated vaccines can be administered saely to per-

sons with altered immunocompetence whether the vaccine isa killed whole-organism or a recombinant, subunit, toxoidpolysaccharide, or polysaccharide protein-conjugate vaccineI inactivated vaccines are indicated or persons with alteredimmunocompetence, the usual doses and schedules are rec-ommended. However, the eectiveness o such vaccinationmight be suboptimal.

Except or inactivated inluenza vaccine, vaccination duringchemotherapy or radiation therapy should be avoided i pos-sible because antibody response might be suboptimal. Patientvaccinated within 14 days beore starting immunosuppressivetherapy or while receiving immunosuppressive therapy shouldbe considered unimmunized and should be revaccinated at least3 months ater therapy is discontinued i immune competencehas been restored.

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Vaccination with Live, AttenuatedViral and Bacterial Vaccines

Severe complications have ollowed vaccination with live,attenuated viral and live, attenuated bacterial vaccines amongpersons with altered immunocompetence (137–145 ). Persons

with most orms o altered immunocompetence should notreceive live vaccines (MMR, varicella, MMRV, LAIV, zoster,yellow ever, Ty21a oral typhoid, BCG, and rotavirus).

Children with deects in phagocyte unction (e.g., chronicgranulomatous disease or myeloperoxidase deiciency) canreceive live, attenuated viral vaccines in addition to inactivatedvaccines but should not receive live, attenuated bacterial vac-cines (e.g., BCG or Ty21a oral typhoid vaccines). Children withdeiciencies in complement or with asplenia can receive live,attenuated viral and live, attenuated bacterial vaccines.

Persons with severe cell-mediated immunodeiciency should not receive live, attenuated viral or bacterial vaccines.

However, two actors support vaccination o HIV-exposedor HIV-inected inants: 1) the HIV diagnosis might not beestablished in inants born to HIV-inected mothers beorethe age o the irst rotavirus vaccine dose (only 1.5% to 3% o HIV-exposed inants in the United States will be determinedto be HIV-inected), and 2) vaccine strains o rotavirus areconsiderably attenuated (136,146 ).

Children with HIV inection are at increased risk or com-plications rom varicella and herpes zoster compared withimmunocompetent children (145,147 ). Limited data amongHIV-inected children (speciically CDC class N, A, or B with age-speciic CD4+ T-lymphocyte percentages o ≥15%)indicate that varicella vaccine is immunogenic, eective, andsae (4,147 ). Varicella vaccine should be considered or chil-dren who meet these criteria. Eligible children should receive2 doses o varicella vaccine with a 3-month interval betweendoses (4,147 ). Doses separated by <3 months are invalid orpersons with altered immunocompetence.

Persons with HIV inection are at increased risk or severecomplications i inected with measles. No severe or unusualadverse events have been reported ater measles vaccinationamong HIV-inected persons who did not have evidence o severe immunosuppression (148–151). Thereore, MMR vac-

cination is recommended or all asymptomatic HIV-inectedpersons who do not have evidence o severe immunosuppres-sion (age-speciic CD4+ T-lymphocyte percentages o ≥15%)and or whom measles vaccination would otherwise be indi-cated. Similarly, MMR vaccination should be considered ormildly symptomatic HIV-inected persons (pediatric category A1 or A2 or adolescent/adult category A) who do not have

evidence o severe immunosuppression (age-speciic CD4+

T-lymphocyte percentages ≥15%) or whom measles vaccina-tion would otherwise be indicated ( 2,146 ). MMRV (licensedonly through age 12 years) should not be administered tochildren or adolescents with HIV inection ( 35 ).

HIV-inected persons who are receiving regular doses o

IGIV might not respond to varicella vaccine or MMR vac-cine because o the continued presence o passively acquiredantibody. However, because o the potential beneit, MMRand varicella vaccines should be considered approximately 14days beore the next scheduled dose o IGIV (i not otherwisecontraindicated), although an optimal immune response mightnot occur depending on the dose and interval since the previoudose o IGIV. Unless serologic testing indicates that speciicantibodies have been produced, vaccination should be repeated(i not otherwise contraindicated) ater the recommendedinterval (Table 5). In most cases, this is ater the therapy hasbeen discontinued. An additional dose o IGIV should be con-sidered or persons receiving maintenance IGIV therapy whoare exposed to measles or varicella ≥3 weeks ater administer-ing a standard dose (100–400 mg/kg body weight) o IGIVPatients with leukemia, lymphoma, or other malignancies whose disease is in remission, who have restored immunocom-petence, and whose chemotherapy has been discontinued orat least 3 months can receive live-virus vaccines. Persons withimpaired humoral immunity (e.g., hypogammaglobulinemiaor dysgammaglobulinemia) may be vaccinated with varicellavaccine (4 ). However, most persons with these disorders alsoreceive periodic doses o IGIV. Appropriate spacing should be

maintained between administration o IGIV and varicella vac-cine to prevent an inadequate response to vaccination causedby the presence o neutralizing antibodies rom the IGIVHousehold members should not receive smallpox vaccine.

Zoster incidence is higher in persons with altered immuno-competence (55 ). Adults with most types o altered immunocompetence are expected to maintain residual immunity tovaricella-zoster virus because o previous inection that protectsagainst primary varicella but provides incomplete protectionagainst zoster. Zoster vaccine is contraindicated in persons withprimary or acquired immunodeiciency (e.g., lymphoma, leu-kemia, tumors involving bone marrow, and patients receiving

chemotherapy) and some patients with AIDS (55 ). ACIP hasno recommendation or or against vaccination o persons withHIV inection with CD4+ T-lymphocyte counts >200 cells/ µLZoster vaccine may be administered to certain persons withaltered immunocompetence, such as persons with HIV inec-tion who have CD4+ T-lymphocyte counts >200 cells/ µL.

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Recipients of HematopoieticCell Transplants

A hematopoietic cell transplant (HCT) results in immu-nosuppression because o the hematopoietic ablative therapy administered beore the transplant, drugs used to prevent or

treat grat-versus-host disease, and, in some cases, rom theunderlying disease process necessitating transplantation (152– 154 ). HCT involves ablation o the bone marrow ollowed by reimplantation o the person’s own stem cells or stem cells roma donor. Antibody titers to vaccine-preventable diseases (e.g.,tetanus, poliovirus, measles, mumps, rubella, and encapsulatedbacteria) decrease 1–4 years ater autologous or allogeneicHCT i the recipient is not revaccinated. HCT recipients o all ages are at increased risk or certain vaccine-preventablediseases, including diseases caused by encapsulated bacteria(i.e., pneumococcal, meningococcal, and Hib inections). As a result, HCT recipients should be revaccinated routinely

ater HCT, regardless o the source o the transplanted stemcells (152 –154 ). Most inactivated vaccines should be initiated6 months ater the HCT (154 ) Inactivated inluenza vaccineshould be administered beginning at least 6 months aterHCT and annually thereater or the lie o the patient. A dose o inactivated inluenza vaccine can be given as early as 4months ater HCT, but a second dose should be considered inthis situation (154 ). A second dose is recommended routinely or all children receiving inluenza vaccine or the irst time.Sequential administration o 3 doses o pneumococcal conjugate vaccine is recommended, beginning 3–6 months aterthe transplant, ollowed by a dose o PPSV (152 ). A 3-doseregimen o Hib vaccine should be administered beginning 6months ater transplant; at least 1 month should separate thedoses (154 ). MMR vaccine should be administered 24 monthsater transplant i the HCT recipient is immunocompetent.Because o insuicient experience using varicella vaccineamong HCT recipients, physicians should assess the immunestatus o each recipient on a case-by-case basis and determinethe risk or inection beore using the vaccine. I a decision ismade to vaccinate with varicella vaccine, the vaccine should beadministered a minimum o 24 months ater transplantationi the HCT recipient is presumed to be immunocompetent

(152,153).

Conditions or Drugs that MightCause Immunodeficiencies

Asplenia and use o corticosteroids or certain drugs have thepotential to be immunosuppressive and are presumed to causesome degree o altered immunocompetence.

Anatomic or Functional Asplenia

Persons with anatomic asplenia (e.g., surgical removal orcongenital absence o the spleen) or unctional asplenia (asoccurs in persons with sickle cell disease) are at increased riskor inection by encapsulated bacteria, especially by S. pneumoniae (pneumococcus), N. meningitidis (meningococcus)and Hib ( 22,49,51). Children aged <5 years with anatomicor unctional asplenia should receive an age-appropriate serieso PCV. Persons aged ≥2 years should receive 2 doses o PPSVseparated by 5 years ( 20,25,28,49 ).

Meningococcal vaccine is recommended or persons withanatomic or unctional asplenia. A speciic MCV4 (Menactra)is approved or persons aged 2–55 years and is the recom-mended vaccine or this age group unless a contraindicationexists. Another MCV4 (Menveo) is approved only or ages11–55 years. Persons aged ≥56 years should receive MPSV4The duration o immunity ater meningococcal vaccination

is not certain; however, on the basis o serologic testing withrecently licensed assays, revaccination is recommended orpersons at continued high risk. A 3-year interval to the nextdose is recommended or children at high risk who receivetheir irst dose at ages 2–6 years. A 5-year interval is recom-mended or persons at high risk who receive their irst doseat age ≥7 years.

No eicacy data are available on which to base a recommen-dation or use o Hib vaccine or older children and adults withthe chronic conditions that are associated with an increasedrisk or Hib disease. Administering 1 dose o Hib vaccine tothese patients who have not previously received Hib vaccine

is not contraindicated.Pneumococcal, meningococcal, and Hib vaccinations should

be administered at least 14 days beore elective splenectomyi possible. I the vaccinations are not administered beoresurgery, they should be administered ater the procedure assoon as the patient’s condition is stable.

Corticosteroids

The amount o systemically absorbed corticosteroids and theduration o administration needed to suppress the immunesystem o an otherwise immunocompetent person are not weldeined. Corticosteroid therapy usually is not a contraindica-

tion to administering live-virus vaccine when administrationis 1) short term (i.e., <14 days); 2) a low to moderate dose(<20 mg o prednisone or equivalent per day); 3) long-termalternate-day treatment with short-acting preparations; 4)maintenance physiologic doses (replacement therapy); or 5)topical (skin or eyes), inhaled, or by intraarticular, bursal, ortendon injection (154 ). No evidence o more severe reactionsto live, attenuated viral vaccines has been reported amongpersons receiving corticosteroid therapy by aerosol, and such

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therapy is not a reason to delay vaccination. Although theimmunosuppressive eects o steroid treatment vary, themajority o clinicians consider a dose equivalent to either≥2 mg/kg o body weight or ≥20 mg/day o prednisone orequivalent or persons who weigh >10 kg when administeredor ≥14 days as suiciently immunosuppressive to raise concern

about the saety o vaccination with live-virus vaccines (154 ).Corticosteroids used in greater than physiologic doses also canreduce the immune response to vaccines. Vaccination providersshould deer live-virus vaccination or at least 1 month aterdiscontinuation o high-dose systemically absorbed corticos-teroid therapy administered or >14 days.

Other Immunosuppressive Drugs

When easible, clinicians should administer all indicated vac-cines to all persons beore initiation o chemotherapy, beoretreatment with other immunosuppressive drugs, and beoreradiation or splenectomy. Persons receiving chemotherapy or

radiation or leukemia and other hematopoietic malignancies,or solid tumors, or ater solid organ transplant should beassumed to have altered immunocompetence. Live, attenu-ated vaccines should not be administered or at least 3 monthsater such immunosuppressive therapy. Inactivated vaccinesadministered during chemotherapy should be readministeredater immune competence is regained. Children receivingchemotherapy or leukemia, lymphoma, other malignancies,or radiation generally are thought to retain immune memory ater treatment, although revaccination with the commonchildhood vaccines ater chemotherapy or acute lymphoblastic

leukemia might be indicated (155 ). In general, revaccination o a person ater chemotherapy or radiation therapy is consideredunnecessary i the previous vaccination occurred beore therapy and not during therapy, with the exception o recipients o HCT, who should be revaccinated as recommended previously.Determination o the level o immune memory and the needor revaccination should be made by the treating physician.

Inactivated vaccines may be administered during low-doseintermittent or maintenance therapy with immunosuppres-sive drugs. The saety and eicacy o live, attenuated vaccinesduring such therapy is unknown. Physicians should careully weigh the risks or and beneits o providing injectable live vac-

cines to adult patients receiving low-dose therapies or chronicautoimmune disease. The saety and eicacy o live, attenuatedvaccines administered concurrently with recombinant humanimmune mediators and immune modulators are unknown.Evidence that use o therapeutic monoclonal antibody preparations, especially the antitumor necrosis actor agentsadalimumab, inliximab, and etanercept, causes reactivationo latent tuberculosis inection and tuberculosis disease andpredisposes persons to other opportunistic inections suggests

caution in the use o live vaccines in patients receiving thesedrugs (127–132 ). Until additional inormation becomes avail-able, avoidance o live, attenuated vaccines during intermit-tent or low-dose chemotherapy or other immunosuppressivetherapy is prudent, unless the beneit o vaccination outweighthe hypothetical increased risk or an adverse reaction ater

vaccination.

Special Situations

Concurrent Administrationof Antimicrobial Agents and Vaccines

With a ew exceptions, use o an antimicrobial agent is nota contraindication to vaccination. Antibacterial agents have noeect on the response to live, attenuated vaccines, except liveoral Ty21a typhoid vaccine, and have no eect on inactivated

recombinant subunit, or polysaccharide vaccines or toxoidsTy21a typhoid vaccine should not be administered to personsreceiving antimicrobial agents until 24 hours ater the last doseo antimicrobial (14 ). I easible, to avoid a possible reductionin vaccine eectiveness, antibacterial drugs should not bestarted or resumed until 1 week ater the last dose o Ty21a.

Antiviral drugs used or treatment or prophylaxis oinluenza virus inections have no eect on the response toinactivated inluenza vaccine (68 ). However, live, attenuatedinluenza vaccine should not be administered until 48 hoursater cessation o therapy with antiviral inluenza drugs. Ieasible, to avoid possible reduction in vaccine eectiveness

antiviral medication should not be administered or 14 daysater LAIV administration (68 ). Antiviral drugs active againstherpesviruses (e.g., acyclovir or valacyclovir) might reduce theeicacy o live, attenuated varicella and zoster vaccines (4,55)These drugs should be discontinued at least 24 hours beoreadministration o vaccines containing varicella zoster virusincluding zoster vaccine, i possible. Delay use or resumptiono antiviral therapy or 14 days ater vaccination. No data existto suggest that commonly used antiviral drugs have an eecton rotavirus vaccine or MMR.

Tuberculosis Screeningand Skin Test ReactivityMeasles illness, severe acute or chronic inections, HIV

inection, and malnutrition can create a relatively anergic stateduring which the tuberculin skin test (TST) might have a alse-negative reaction (156–158 ). Although any live, attenuatedmeasles vaccine theoretically can suppress TST reactivity, thedegree o suppression is likely less than that occurring romacute inection rom wild-type measles virus. Although routine

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TST screening o all children is no longer recommended,TST screening is sometimes needed (e.g., or well child care,school entrance, or employee health reasons) at the same timeas administration o a measles-containing vaccine.

The TST and measles-containing vaccine can be admin-istered at the same visit (preerred option). Simultaneously

administering the TST and measles-containing vaccine doesnot interere with reading the TST result at 48–72 hours andensures that the person has received measles vaccine.

I the measles-containing vaccine has been administeredrecently, TST screening should be delayed or at least 4 weeksater vaccination. A delay in perorming the TST removes theconcern o any theoretical but transient suppression o TSTreactivity rom the vaccine.

TST screening can be perormed and read beore adminis-tration o the measles-containing vaccine. This option is theleast avored because it delays receipt o the measles-containingvaccine. I a person is suspected to have tuberculosis, not only should the MMR vaccine be withheld beore the TST, it shouldbe withheld until ater treatment has been initiated because aperson with active tuberculosis who is moderately or severely ill should not receive MMR vaccine. In a general screeningsituation in which tuberculosis is not suspected, a TST may be administered simultaneously with live vaccines or shouldbe deerred or 28 days ater vaccination.

No data exist regarding the potential degree o TST sup-pression that might be associated with other live, attenuatedvirus vaccines (e.g., varicella or yellow ever). However, in theabsence o data, ollowing guidelines or measles-containing

vaccine when scheduling TST screening and administeringother live, attenuated virus vaccines is prudent. I the oppor-tunity to vaccinate might be missed, vaccination should notbe delayed only because o these theoretical considerations.Because o similar concerns about smallpox vaccine and TSTsuppression, a TST should not be perormed until 4 weeksater smallpox vaccination (159 ).

A more speciic test or diagnosis o tuberculosis or latenttuberculosis inection was licensed in 2005. The intereron-gamma release assay (IGRA) requires only one visit to completeand is less sensitive to the eects o previous BCG vaccination(160 ). The same timing guidelines that apply to the interval

between a live vaccine and TST apply to IGRA (i.e., 28 daysbetween live vaccine and IGRA i they do not occur on thesame day), because IGRA (like TST) might be suppressedthrough immunologic mechanisms.

The potential or TST to cause boosting o results should beconsidered in adults who might have latent tuberculosis andhave a negative initial TST (160 ). The two-step tuberculin testis recommended or certain situations (160 ). Because this testconsists o two TSTs (or a TST ollowed by IGRA) separated

by an interval o 1–3 weeks, there is a greater window o timeduring which live vaccine replication could suppress reactivityI a live vaccine is administered, the irst dose o a two-step TSTshould be delayed or 4 weeks, and i additional doses o livevaccines are indicated thereater, they should be delayed untithe second TST (or the IGRA ater an initial TST).

TST or IGRA reactivity in the absence o tuberculosis diseaseis not a contraindication to administration o any vaccineincluding live, attenuated virus vaccines. Tuberculosis diseaseis not a contraindication to vaccination, unless the person ismoderately or severely ill. Although no studies have reportedon the eects o MMR vaccine on persons with untreatedtuberculosis, a theoretical basis exists or concern that measlesvaccine might exacerbate tuberculosis disease ( 2 ). As a resultbeore administering MMR to persons with untreated activetuberculosis, initiating antituberculosis therapy is advisable ( 2 )Considering whether concurrent immunosuppression (e.g.immunosuppression caused by HIV inection) is a concernbeore administering live, attenuated vaccines also is prudent.

Severe Allergy to Vaccine ComponentsVaccine components can cause allergic reactions among

certain recipients. These reactions can be local or systemicand can include anaphylaxis or anaphylactic-like response(e.g., generalized urticaria or hives, wheezing, swelling o themouth and throat, dyspnea, hypotension, and shock). Allergicreactions might be caused by the vaccine antigen, residualanimal protein, antimicrobial agents, preservatives, stabiliz-ers, or other vaccine components (161). Children who have

had an apparent severe allergic reaction to a vaccine should beevaluated by an allergist to determine the responsible allergenand to make recommendations regarding uture vaccinationComponents o each vaccine are listed in the respective pack-age insert. An extensive list o vaccine components and theiruse, as well as the vaccines that contain each component, habeen published (162 ) and also is available rom CDC (http:// www.cdc.gov/vaccines).

The most common animal protein allergen is egg protein which is ound in inluenza and yellow ever vaccines becausethey are prepared using embryonated chicken eggs. Ordinarilypersons who are able to eat eggs or egg products saely canreceive these vaccines; persons who have had an anaphylacticor anaphylactic-like allergy to eggs or egg proteins generallyshould not receive these vaccines. Asking persons i they can eateggs without adverse eects is a reasonable way to determine which persons might be at risk or allergic reactions rom yel-low ever and inluenza vaccines. A regimen or administeringinluenza vaccine to children with egg hypersensitivity andsevere asthma has been developed (163,164 )





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Measles and mumps vaccine viruses are grown in chick embryo ibroblast tissue culture. However, persons with asevere egg allergy can receive measles- or mumps-containingvaccines without skin testing or desensitization to egg protein( 2 ). Rubella and varicella vaccines are grown in human diploidcell cultures and can saely be administered to persons with a

severe allergy to eggs or egg proteins. The rare severe allergicreactions ater measles or mumps vaccination or MMR arenot thought to be caused by egg antigens but to other compo-nents o the vaccine (e.g., gelatin) (165–168 ). MMR, MMRV,and other vaccines contain hydrolyzed gelatin as a stabilizer.Extreme caution should be used when administering vaccinesthat contain gelatin to persons who have had an anaphylacticreaction to gelatin or gelatin-containing products.

Certain vaccines contain trace amounts o antimicrobialagents or other preservatives (e.g., neomycin or thimerosal)to which patients might be allergic, although such allergiesare rare. The inormation provided in vaccine package insertsshould be reviewed careully beore deciding whether a patient with such allergies should receive the vaccine. No licensed vac-cine contains penicillin or penicillin derivatives.

Persons who have had anaphylactic reactions to neomycinshould not receive vaccines containing neomycin. Most oten,a neomycin allergy is a contact dermatitis, a maniestation o a delayed-type (cell-mediated) immune response rather thananaphylaxis (169,170 ). A history o delayed-type reactionsto neomycin is not a contraindication or administration o these vaccines.

Thimerosal, an organic mercurial compound in use since

the 1930s, is added to certain immunobiologics as a preserva-tive. Since mid-2001, vaccines routinely recommended oryoung inants have been manuactured without thimerosal asa preservative. Live, attenuated vaccines have never containedthimerosal. Thimerosal-ree ormulations o inactivated inlu-enza vaccine are available. Inactivated inluenza vaccine alsois available in ormulations with trace thimerosal, in whichthimerosal remains as a manuacturing residual but does notunction as a preservative, and in ormulations that containthimerosal as a preservative. Thimerosal at a preservativeconcentration is present in certain other vaccines that canbe administered to children (e.g., Td and DT). Inormation

about the thimerosal content o vaccines is available rom FDA (http://www.da.gov/cber/vaccine/thimerosal.htm).

On the basis o limited scientiic data, some investigatorshave asserted that receiving thimerosal-containing vaccinesmight induce an allergy. Allergies to thimerosal usually havebeen described as local delayed-type hypersensitivity reactions(171–173). Thimerosal elicits positive delayed-type hyper-sensitivity patch tests in 1%–18% o persons tested; however,these tests have limited or no clinical relevance (174,175 ). The

majority o persons do not experience reactions to thimerosaadministered as a component o vaccines even when patch orintradermal tests or thimerosal indicate hypersensitivity (175 ) A local or delayed-type hypersensitivity reaction to thimerosalis not a contraindication to receipt o a vaccine that containthimerosal.

Latex AllergyLatex is sap rom the commercial rubber tree. Latex contain

naturally occurring impurities (e.g., plant proteins and pep-tides) that might be responsible or allergic reactions. Latex isprocessed to orm natural rubber latex and dry, natural rubberNatural rubber latex and dry, natural rubber might contain thesame plant impurities as latex but in lesser amounts. Naturarubber latex is used to produce medical gloves, cathetersand other products. Dry, natural rubber is used in the tip osyringe plungers, the tip on preilled syringes, vial stoppers

and injection ports on intravascular tubing. Synthetic rubberand synthetic latex also are used in medical gloves, syringeplungers, and vial stoppers. Synthetic rubber and syntheticlatex do not contain natural rubber or natural latex and do notcontain impurities linked to allergic reactions. Latex or drynatural rubber used in vaccine packaging generally is noted inthe manuacturers’ package inserts.

The most common type o latex sensitivity is a contact-type(type 4) allergy, usually as a result o prolonged contact withlatex-containing gloves (176 ). However, latex allergies associated with injection procedures have been described among patient with diabetes mellitus (177–179 ). Allergic reactions (including

anaphylaxis) ater vaccinations are rare. A review o reports toVAERS identiied only 28 cases o possible immediate-typeanaphylactic reactions among more than 160,000 vaccine adverseevent reports (180 ).

I a person reports a severe (anaphylactic) allergy to latex,vaccines supplied in vials or syringes that contain naturarubber latex should not be administered unless the beneit ovaccination clearly outweighs the risk or a potential allergicreaction. In these cases, providers should be prepared to treapatients who are having an allergic reaction. For latex allergiesother than anaphylactic allergies (e.g., a history o contacallergy to latex gloves), vaccines supplied in vials or syringesthat contain dry, natural rubber or natural rubber latex maybe administered.

Vaccination of Preterm InfantsIn the majority o cases, preterm inants (inants born beore

37 weeks’ gestation), regardless o birth weight, should bevaccinated at the same chronological age and according to thesame schedule and using the same precautions as or ull-term

http://www.fda.gov/cber/vaccine/thimerosal.htm

http://www.fda.gov/cber/vaccine/thimerosal.htm

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inants and children. Birth weight and size are not actorsin deciding whether to vaccinate a clinically stable preterminant (181–185 ), except or hepatitis B vaccination. The ullrecommended dose o each vaccine should be used. Dividedor reduced doses are not recommended.

Decreased seroconversion rates might occur among certain

preterm inants (i.e., with low birth weights [<2,000 g])ater administration o hepatitis B vaccine at birth (186 ).However, by the chronological age o 1 month, all preterminants, regardless o initial birth weight, are likely to respondas adequately as larger inants (187–189 ). Preterm inantsborn to HBsAg-positive mothers and mothers with unknownHBsAg status must receive immunoprophylaxis with hepatitisB vaccine within 12 hours ater birth. The initial vaccine doseshould not be counted toward completion o the hepatitis Bseries, and 3 additional doses o hepatitis B vaccine should beadministered, beginning when the inant is aged 1 month.For mothers with unknown HBsAg status, attempts should bemade to determine HBsAg status. The inant must be givenHBIG within 12 hours o birth unless the mother is ound tobe HBsAg negative ( 26 ). Inants weighing <2,000 g born toHBsAg-negative mothers should receive the irst dose o thehepatitis B series at chronological age 1 month or at hospitaldischarge.

I a child aged at least 6 weeks has been in the hospital sincebirth, deerral o rotavirus vaccine is recommended until thetime o discharge (136 ). The rotavirus vaccine series shouldnot be initiated or inants aged ≥15 weeks, 0 days.

Breastfeeding and VaccinationNeither inactivated nor live-virus vaccines administered to a

lactating woman aect the saety o breasteeding or womenor their inants. Although live viruses in vaccines can replicatein vaccine recipients (i.e., the mother), the majority o liveviruses in vaccines have been demonstrated not to be excretedin human milk. Varicella vaccine virus has not been ound inhuman milk (190 ). Although rubella vaccine virus might beexcreted in human milk, the virus usually does not inect theinant. I inection does occur, it is well tolerated because thevirus is attenuated (191). Inactivated, recombinant, subunit,polysaccharide, and conjugate vaccines, as well as toxoids, poseno risk or mothers who are breasteeding or or their inants.Breasteeding is a contraindication or smallpox vaccinationo the mother because o the theoretical risk or contact trans-mission rom mother to inant. Yellow ever vaccine should beavoided in breasteeding women (19 ). However, when nursingmothers cannot avoid or postpone travel to areas endemic oryellow ever in which risk or acquisition is high, these womenshould be vaccinated.

Limited data indicate that breasteeding can enhance theresponse to certain vaccine antigens (192 ). There are no datato suggest that passive transer o antibodies in human milkcan aect the eicacy o live-virus vaccines. Breasted inantsshould be vaccinated according to the recommended schedule(193–195 ).

Vaccination During PregnancyRisk to a developing etus rom vaccination o the mother

during pregnancy is theoretical. No evidence exists o risk tothe etus rom vaccinating pregnant women with inactivatedvirus or bacterial vaccines or toxoids (196,197 ). Live vaccinesadministered to a pregnant woman pose a theoretical risk tothe etus; thereore, live, attenuated virus and live bacterial vaccines generally are contraindicated during pregnancy. Beneitso vaccinating pregnant women usually outweigh potentiarisks when the likelihood o disease exposure is high, when

inection would pose a risk to the mother or etus, and whenthe vaccine is unlikely to cause harm. Recommendations orvaccination during pregnancy are developed using ACIP’sGuiding Principles for Development of ACIP Recommendation for Vaccination During Pregnancy and Breastfeeding (198 ).

Pregnant women who received the last dose o tetanus-toxoid–containing vaccine >10 years previously should gener-ally receive Td rather than Tdap while they are pregnant (16 )although Tdap is not contraindicated during pregnancy. A doseo Td during pregnancy ensures adequate tetanus immunityin the mother and prevents disease in both mother and inantIn speciic situations, the dose o Td can be withheld i the

provider is conident the pregnant woman is immune to tetanus(199 ). Regardless o a recent Td vaccination, pregnant women who have not already received Tdap should receive a dose oTdap as soon as possible ater delivery to ensure pertussiimmunity and reduce the risk or transmission to the newbornPregnant women who are not vaccinated or are only partiallyvaccinated against tetanus should complete the primary series(16 ). Women or whom Td is indicated but who did notcomplete the recommended 3-dose series during pregnancyshould receive ollow-up ater delivery to ensure the series iscompleted. Because Tdap is recommended as a one-time dosepregnant women who previously have received Tdap shouldreceive Td i indicated.

Women in the second and third trimesters o pregnancy areat increased risk or hospitalization rom inluenza (68,200 )Because vaccinating against inluenza beore the season beginsis critical, and because predicting exactly when the season wilbegin is impossible, routine inluenza vaccination is recom-mended or all women who are or will be pregnant (in any

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trimester) during inluenza season, which in the United Statesis usually early October through late March (68 ).

IPV can be administered to pregnant women who are atrisk or exposure to wild-type poliovirus inection ( 201).Hepatitis A, pneumococcal polysaccharide, meningococcalconjugate, and meningococcal polysaccharide vaccines should

be considered or women at increased risk or those inections(49,51,202 ). Pregnant women who must travel to areas wherethe risk or yellow ever is high should receive yellow evervaccine because the limited theoretical risk rom vaccinationis outweighed substantially by the risk or yellow ever inec-tion (19,203). Hepatitis B vaccine is not contraindicated inpregnancy and should be given to a pregnant woman who hasan indication or hepatitis B vaccine ( 26,204 ).

Pregnancy is a contraindication or smallpox (vaccinia) vac-cine and measles-, mumps-, rubella-, and varicella-containingvaccines. Smallpox vaccine is the only vaccine known to harma etus when administered to a pregnant woman. In addition,smallpox vaccine should not be administered to a householdcontact o a pregnant woman (159 ). Data rom studies o children born to mothers vaccinated with rubella vaccineduring pregnancy demonstrate rubella antibody levels inunvaccinated inants. This could represent passive transer o maternal antibody or a etal antibody response to vaccine virusinection in the etus. No cases o congenital rubella or vari-cella syndrome or abnormalities attributable to etal inectionhave been observed among inants born to susceptible women who received rubella or varicella vaccines during pregnancy ( 205–207 ). Because o the importance o protecting women

o childbearing age against rubella and varicella, reasonablepractices in any vaccination program include asking womeni they are pregnant or might become pregnant in the next 4 weeks; not vaccinating women who state that they are or planto become pregnant; explaining the theoretical risk or theetus i MMR, varicella, or MMRV vaccine were administeredto a woman who is pregnant; and counseling women who arevaccinated not to become pregnant during the 4 weeks aterMMR, varicella, or MMRV vaccination ( 2,59,205–207 ).MMRV is an unlikely option or a pregnant woman becausethe vaccine is only licensed through 12 years o age. Routinepregnancy testing o women o childbearing age beore

administering a live-virus vaccine is not recommended ( 2,4 ).I a pregnant woman is inadvertently vaccinated or becomespregnant within 4 weeks ater MMR or varicella vaccination,she should be counseled about the theoretical basis o concernor the etus; however, MMR or varicella vaccination duringpregnancy should not be considered a reason to terminatepregnancy ( 2,4,207 ).

Persons who receive MMR vaccine do not transmit the vac-cine viruses to contacts ( 2 ). Transmission o varicella vaccine

virus to contacts is rare (4 ). MMR and varicella vaccinesshould be administered when indicated to children and otherhousehold contacts o pregnant women ( 2,4 ). Inants living inhouseholds with pregnant women should be vaccinated withrotavirus vaccine according to the same schedule as inants inhouseholds without pregnant women.

Pregnant women should be evaluated or immunity to rubellaand varicella and be tested or the presence o HBsAg duringevery pregnancy ( 2,26,60 ). Women susceptible to rubellaand varicella should be vaccinated immediately ater delivery A woman ound to be HBsAg positive should be monitoredcareully to ensure that the inant receives HBIG and beginsthe hepatitis B vaccine series no later than 12 hours ater birthand that the inant completes the recommended hepatitis Bvaccine series on schedule ( 26 ). No known risk exists or theetus rom passive immunization o pregnant women withimmune globulin preparations.

Persons Vaccinated Outsidethe United States

Clinicians have a limited ability to determine whether per-sons are protected on the basis o their country o origin andtheir records alone. Vaccines administered outside the UnitedStates generally can be accepted as valid i the schedule (i.e.minimum ages and intervals) is similar to that recommendedin the United States. With the exception o the inluenzavaccine and PPSV, only written documentation should beaccepted as evidence o previous vaccination. Written recordare more likely to predict protection i the vaccines, dates oadministration, intervals between doses, and age at the timeo vaccination are comparable to U.S. recommendations Although vaccines with inadequate potency have been produced in other countries ( 208,209 ), the majority o vaccinesused worldwide are produced with adequate quality controstandards and are potent.

The number o U.S. amilies adopting children rom outsidethe United States has increased substantially in the last decade( 209 ). Adopted children’s birth countries oten have vaccination schedules that dier rom the recommended childhoodvaccination schedule in the United States. Dierences in the

U.S. schedule and those used in other countries include thevaccines administered, the recommended ages o administra-tion, and the number and timing o doses.

Data are inconclusive regarding the extent to which an inter-nationally adopted child’s vaccination record relects the child’sprotection. A child’s record might indicate administration oMMR vaccine when only single-antigen measles vaccine wasadministered. A study o children adopted rom orphanages inthe People’s Republic o China, Russia, and countries in Eastern

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Europe determined that 67% o children with documentationo >3 doses o DTP beore adoption had nonprotective titersto these antigens ( 209 ). In contrast, children adopted romthese countries who received vaccination in the community (not only rom orphanages) and had documentation o ≥1doses o DTP exhibited protective titers 67% o the time ( 209 ).

However, antibody testing was perormed by using a hemag-glutination assay, which tends to underestimate protectionand cannot directly be compared with antibody concentration( 210 ). Data are likely to remain limited or areas other thanthe People’s Republic o China, Russia, and Eastern Europe.Health-care providers should ensure that household contacts o international adoptees are vaccinated adequately, particularly or measles, hepatitis A, and hepatitis B ( 211).

Health-care providers may use one o multiple approachesi the immunogenicity o vaccines administered to personsoutside the United States is in question. Repeating the vaccina-tions is an acceptable option that usually is sae and preventsthe need to obtain and interpret serologic tests. I avoidingunnecessary injections is desired, judicious use o serologictesting might help determine which vaccinations are needed.For some vaccines, the most readily available serologic testscannot document protection against inection. These recom-mendations provide guidance on possible approaches to evalu-ation and revaccination or each vaccine recommended in theUnited States (Table 14).

DTaP Vaccine

Vaccination providers can revaccinate children with DTaP

vaccine without regard to recorded doses; however, data indi-cate increased rates o local adverse reactions ater the ourthand ith doses o DTaP (67 ). I a revaccination approach isadopted and a severe local reaction occurs, serologic testingor speciic IgG antibody to tetanus and diphtheria toxins canbe measured beore administering additional doses. Protectiveconcentration¶¶ indicates that additional doses are unnecessary and subsequent vaccination should occur as age-appropriate.No established serologic correlates exist or protection againstpertussis.

For a child whose record indicates receipt o ≥3 doses o DTP or DTaP, serologic testing or speciic IgG antibody to

both diphtheria and tetanus toxin beore additional doses is areasonable approach. I a protective concentration is present,recorded doses are considered valid, and the vaccination seriesshould be completed as age appropriate. An indeterminateantibody concentration might indicate immunologic memory

but waning antibody; serologic testing can be repeated ater abooster dose i the vaccination provider wants to avoid revaccination with a complete series.

Alternately, or a child whose records indicate receipt o ≥3doses, a single booster dose can be administered ollowed byserologic testing ater 1 month or speciic IgG antibody to

both diphtheria and tetanus toxins. I the child has a protectiveconcentration, the recorded doses are considered valid, andthe vaccination series should be completed as age appropriateChildren with an indeterminate concentration ater a boosterdose should be revaccinated with a complete series.

Hepatitis A Vaccine

Children aged 12–23 months without documentation ohepatitis A vaccination or serologic evidence o immunityshould be vaccinated on arrival in the United States ( 202 )Persons who have received 1 dose should receive the seconddose i 6–18 months have passed since the irst dose was

administered.

Hepatitis B Vaccine

Persons not known to be vaccinated or hepatitis B shouldreceive an age-appropriate series o hepatitis B vaccine. A per-son whose records indicate receipt o ≥3 doses o vaccine areconsidered protected, and additional doses are not needed i ≥1dose was administered at age ≥24 weeks. Persons who receivedtheir last hepatitis B vaccine dose at an age <24 weeks shouldreceive an additional dose at age ≥24 weeks. People who havereceived <3 doses o vaccine should complete the series at therecommended intervals and ages.

All oreign-born persons and immigrants, reugees, and interna-tionally adopted children born in Asia, the Paciic Islands, Aricaand other regions o high or intermediate endemicity should betested or HBsAg, regardless o vaccination status ( 212 ). Thosedetermined to be HBsAg-positive should be monitored ordevelopment o liver disease. Household members o HBsAg-positive children or adults should be vaccinated i they are notalready immune.

Hib Vaccine

Interpretation o a serologic test to veriy whether children

who were vaccinated >2 months previously are protectedagainst Hib bacteria can be diicult. Because the number ovaccinations needed or protection decreases with age andbecause adverse events are rare ( 22 ), age-appropriate vaccina-tion should be provided. Hib vaccination is not recommendedroutinely or persons aged ≥5 years ( 20 ).

¶¶ Enzyme immunoassay tests are available. Physicians should contact the labora-tory perorming the test or interpretive standards and limitations. Protectiveconcentrations or antibody to diphtheria and tetanus toxins are deined as>0.1 IU/mL.

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MMR Vaccine

The simplest approach to resolving concerns about MMR vaccination is to revaccinate with 1 or 2 doses o MMR vac-cine, depending on age. Serious adverse events ater MMR vaccinations are rare ( 2 ). No evidence indicates that admin-istering MMR vaccine increases the risk or adverse reactionsamong persons who are already immune to measles, mumps,or rubella as a result o previous vaccination or natural disease.Doses o measles-containing vaccine administered beore theirst birthday should not be counted as part o the series ( 2 ). Alternatively, serologic testing or IgG antibody to vaccineviruses indicated on the vaccination record can be considered.Serologic testing is widely available or measles and rubella IgGantibody. A person whose record indicates receipt o mon-ovalent measles or measles-rubella vaccine on or ater the irstbirthday and who has protective antibody against measles andrubella should receive 1 or 2 doses o MMR or MMRV as age

appropriate to ensure protection against mumps and varicella(and rubella i measles vaccine alone had been administered).I a person whose record indicates receipt o MMR at age ≥12months has a protective concentration o antibody to measles,no additional vaccination is needed unless a second dose isrequired or school entry.

Pneumococcal Vaccines

Many industrialized countries are now routinely using pneu-mococcal vaccines. Although recommendations or pneumo-coccal polysaccharide vaccine also exist in many countries, thevaccine might not be routinely administered. PCV and PPSV

should be administered according to age-appropriate vaccina-tion schedules or as indicated by the presence o underlyingmedical conditions ( 25,49 ).

Poliovirus Vaccine

The simplest approach to vaccinating with poliovirus vaccineis to revaccinate persons aged <18 years with IPV accordingto the U.S. schedule. Adverse events ater IPV are rare ( 201).Children appropriately vaccinated with 3 doses o OPV ineconomically developing countries might have suboptimalseroconversion, including to type 3 poliovirus ( 201). Serologictesting or neutralizing antibody to poliovirus types 1, 2, and

3 can be obtained commercially and at certain state healthdepartment laboratories. Persons with protective titers againstall three types do not need to repeat doses but should completethe schedule as age appropriate.

Rotavirus Vaccine

Rotavirus vaccination should not be initiated or inants aged≥15 weeks, 0 days. Inants who began the rotavirus vaccineseries outside the United States but who did not complete

the series and who are still aged ≤8 months, 0 days, shouldollow the routine schedule and receive doses to complete theseries. I the brand o a previously administered dose is RV5or unknown, a total o 3 doses o rotavirus vaccine shouldbe documented or series completion. All doses should beadministered by age 8 months, 0 days.

Td and Tdap Vaccines

Children aged ≥7 years who need the primary series doses otetanus-toxoid–containing vaccine should receive Td or Tdapas age appropriate.

Varicella Vaccine

Varicella vaccine is not available in the majority o countries A person who lacks reliable evidence o varicella immunityshould be vaccinated as age appropriate (4,20 ).

Zoster Vaccine

Zoster vaccination is recommended or all persons aged ≥60years who have no contraindications, including persons whoreport a previous episode o zoster or who have chronic medicalconditions. The vaccine should be oered at the patient’s irstclinical encounter with the health-care provider. The vaccine isadministered as a single 0.65-mL subcutaneous dose. Zoster vac-cination is not indicated to treat acute zoster, to prevent persons with acute zoster rom developing postherpetic neuralgia, or totreat ongoing postherpetic neuralgia. Beore administration ozoster vaccine, patients do not need to be asked about their historyo varicella or to have serologic testing conducted to determinezoster immunity.

Vaccinating Personswith Bleeding Disorders

Because o the risk or hematoma ormation ater injectionsintramuscular injections are oten avoided among persons withbleeding disorders by using the subcutaneous or intradermaroutes or vaccines that normally are administered intramus-cularly. In one study, hepatitis B vaccine was administeredintramuscularly to 153 persons with hemophilia. The vac-cination was administered with a 23-gauge or smaller caliberneedle, ollowed by application o steady pressure to the siteor 1–2 minutes. The vaccinations resulted in a low (4%)bruising rate, and no patients required actor supplementation( 213). Whether antigens that produce more local reactions(e.g., pertussis) would produce an equally low rate o bruisingis unknown.

When hepatitis B or any other intramuscularly administeredvaccine is indicated or a patient with a bleeding disorder, thevaccine should be administered intramuscularly i a physician

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amiliar with the patient’s bleeding risk determines that thevaccine can be administered by this route with reasonablesaety. I the patient receives antihemophilia or similar therapy,intramuscularly administered vaccinations can be scheduledshortly ater such therapy is administered. A ine-gauge needle(23 gauge or smaller caliber) should be used or the vaccina-

tion, ollowed by irm pressure on the site, without rubbing,or at least 2 minutes. The patient or amily should be giveninormation on the risk or hematoma rom the injection.Patients receiving anticoagulation therapy presumably havethe same bleeding risk as patients with clotting actor disor-ders and should ollow the same guidelines or intramuscularadministration.

Vaccination Records

Records of Health-Care Providers Appropriate and timely vaccination documentation helps

ensure not only that persons in need o recommended vac-cine doses receive them but also that adequately vaccinatedpatients do not receive excess doses. Curtailing the number o excess doses administered to patients controls costs incurred by patients, providers, insurers, vaccination programs, and otherstakeholders. In addition, excess doses o inactivated vaccinesmight increase the risk or an adverse reaction. Health-careproviders who administer vaccines covered by the NationalChildhood Vaccine Injury Act are required to ensure that thepermanent medical record o the recipient (or a permanent

oice log or ile) indicates the date the vaccine was adminis-tered, the vaccine manuacturer, the vaccine lot number, andthe name, address, and title o the person administering thevaccine. In addition, the provider is required to record theedition date o the VIS distributed and the date those materi-als were provided. The act considers a health-care providerto be any licensed health-care proessional, organization, orinstitution, whether private or public (including ederal, state,and local departments and agencies), under whose authority a speciied vaccine is administered. This inormation shouldbe kept or all vaccines, not just or those required by the act.Providers and sta members also should systematically update

patient’s permanent medical records to relect any documentedepisodes o adverse events ater vaccination and any serologictest results related to vaccine-preventable diseases (e.g., thoseor rubella screening and antibody to HBsAg).

Personal Records of PatientsOicial childhood vaccination records have been adopted

by every state and territory and the District o Columbia to

encourage uniormity o records and to acilitate assessmento vaccination status by schools and child-care centers. Therecords also are key tools in vaccination education programsaimed at increasing parental and patient awareness o the needor vaccines. A permanent vaccination record card should beestablished or each newborn inant and maintained by the

parent or guardian. The parent or guardian should be educatedabout the importance o keeping the record up to date andinstructed to keep the record indeinitely as part o the child’spermanent medical record. These cards should be distributed tonew mothers beore discharge rom the hospital. Using vaccina-tion record cards or adolescents and adults also is encouragedStandardized adult vaccination records are available at http:// www.immunize.org.

Immunization Information SystemsIISs (ormerly reerred to as immunization registries) are

conidential, population-based, computerized inormationsystems that collect and consolidate vaccination data rommultiple health-care providers within a geographic area. IISsare a critical tool that can increase and sustain vaccinationcoverage by consolidating vaccination records rom multipleproviders, generating reminder and recall vaccination noticeor each person, and providing oicial vaccination orms andvaccination coverage assessments ( 214 ).

Changing vaccination providers during the course o anindividual’s vaccination series is common in the United StatesThe 2007 National Health Interview Survey Summary HealthStatistics or U.S. Children documented that 95% o children

have a usual place o health care; 6% go to more than one healthvenue most o the time. Individual eligibility or Medicaid andresulting enrollment in Medicaid managed-care health planstends to be sporadic, with an average duration o 9 monthsand a median o <12 months in 2000 ( 215 ). In addition tochanges in providers, the vaccination records o persons whohave changed vaccination providers oten are unavailableor incomplete or might not have been entered into an IIS( 214 ). Missing or inaccurate inormation regarding vaccinesreceived previously might preclude accurate determination o which vaccines are indicated at the time o a visit, resulting inadministration o extra doses.

A ully operational IIS also can prevent duplicate vaccinations,limit missed appointments, reduce vaccine waste, and reducesta time required to produce or locate vaccination recordsor certiicates. Most IISs have additional capabilities, suchas vaccine management, maintenance o lietime vaccinationhistories, and interoperability with other health inormationsystems. The National Vaccine Advisory Committee stronglyencourages development o community- or state-based IISs





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and recommends that vaccination providers participate in thesesystems when possible. One o the national health objectivesor 2010 was 95% participation o children aged <6 years in aully operational population-based IIS (objective 20.1) ( 216 ).Participating in an IIS means having two or more vaccinationsrecorded in the IIS. 2008 IIS data indicate that approximately

75% o children aged <6 years with two or more vaccinations were participating in IISs ( 217 ). Inclusion o adults into IISsalso would be worthwhile. A new national health objectiveor 2020 is 80% o adolescents (aged 11–18 years) with twoor more age-appropriate vaccinations recorded in IISs (http:// www.healthypeople.gov/hp2020/objectives/topicarea.aspx?id=30&topicarea=immunization+and+inectious+diseases).

Vaccination ProgramsIn the United States, vaccination programs have eliminated

many vaccine-preventable diseases and reduced the incidence o several others ( 218 ). Because inants and young children werethe principle recipients o most vaccines developed during thetwentieth century (e.g., poliovirus vaccine), many persons inthe United States might believe that vaccinations are solely orthe young; however, vaccinations are recommended or personso all ages ( 20,28 ). Improved vaccination coverage can result inadditional reductions in the incidence o vaccine-preventablediseases and decrease associated morbidity and mortality.Universal vaccination is a critical part o quality health careand should be accomplished through routine and catch-upvaccination provided in physicians’ oices, public health

clinics, and other appropriate complementary settings. Every patient encounter represents an opportunity to review and, when needed, improve a patient’s vaccination status throughadministration o recommended vaccines.

Vaccination of Children and AdolescentsPhysicians and other pediatric vaccination providers should

adhere to the standards or child and adolescent vaccinationpractices (8 ). These standards were published by the NationalVaccine Advisory Committee and deine appropriate vaccina-tion practices or both public and private sectors. The standards

provide guidance on practices that eliminate barriers to vaccina-tion, including eliminating unnecessary prerequisites or receiv-ing vaccinations, eliminating missed opportunities to vaccinate,improving procedures to assess vaccination needs, enhancingknowledge about vaccinations among parents and providers,and improving management and reporting o adverse events.In addition, the standards address the importance o recall andreminder systems and using assessments to monitor clinic oroice vaccination coverage levels. Health-care providers should

simultaneously administer as many vaccine doses as possibleas indicated on the Recommended Immunization Schedules foPersons Aged 0 Through 18 Years ( 20 ).

Community health-care providers, as well as sta membersat both state and local vaccination programs, should coordi-nate with partners to maximize outreach to populations at

risk or undervaccination and vaccine-preventable diseasesFor example, the Special Supplemental Nutrition Programor Women, Inants, and Children (WIC) is a categoricalederal grant program administered by the U.S. Departmento Agriculture through state health departments. The pro-gram provides supplemental oods, health-care reerrals, andnutrition education to low-income pregnant, breasteedingor postpartum women, as well as to inants and childrenaged <5 years. More than 8.7 million people participated inthis program in 2008 (http://www.ns.usda.gov/pd/wicmainhtm). In collaboration, WIC and state vaccination programsshould assess regularly the vaccination coverage levels o WICparticipants and develop new strategies and aggressive outreachprocedures in sites with coverage levels <90%. Vaccinationprograms and private providers are encouraged to reer eligiblechildren to obtain WIC nutritional services ( 219 ).

Adolescents

Vaccinations are recommended throughout lie, includingduring adolescence. The age range or adolescence is deined as11–21 years by many proessional associations, including the American Academy o Pediatrics and the American Medica Association ( 220,221). Deinitions o these age cutos dier

depending on the source o the deinition and the source’spurpose or creating a deinition. Vaccination o adolescentsis critical or preventing diseases or which adolescents are atparticularly high or increasing risk, such as meningococcadisease and human papillomavirus inection. Three vaccinesrecommended or adolescents have been licensed since 2005MCV4, HPV, and the Tdap vaccine. A second dose o varicellavaccine is recommended or persons who received 1 dose ovaricella vaccine ater age 12 months, and this group includesmany adolescents. In addition, annual seasonal inluenza vac-cination is recommended or persons aged >6 months who haveno contraindications. To ensure vaccine coverage, clinicians and

other health-care providers who treat adolescents must screenor a complete vaccination history on every occasion that anadolescent has an oice visit.

National goals or vaccination coverage or adolescents aged13–15 years were included in Healthy People 2010 ( 216 )Targets or 90% coverage were speciied or established vaccinerecommendations including those or 3 doses o hepatitis Bvaccine, 1 dose o MMR vaccine, 1 dose o varicella vaccine(excluding persons with a history o varicella), and 1 dose o

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Td vaccine. Results o the published 2008 NationalImmunization Survey—Teen indicate that, or the irst time,coverage targets or hepatitis B and MMR vaccines were met.For ≥1 dose o varicella, coverage increased to 86%. However,coverage or ≥1 dose o either Td or Tdap was unchanged at71%, remaining below the coverage target o 90%. Coverage

or MCV4 is 42%. New objectives rom Healthy People 2020 include 1 dose o Tdap and ≥2 doses o varicella vaccine(excluding persons who have had varicella disease) (http://www. healthypeople.gov/hp2020/objectives/topicarea.aspx?id=30&topicarea=immunization+and+inectious+diseases).

Ensuring adolescents receive routine and catch-up vaccina-tion and increasing vaccination coverage in this age group pres-ent challenges. In general, adolescents do not visit health-careproviders requently. Health-care providers should promoteannual preventive visits ( 217 ), including one speciically oradolescents aged 11 and 12 years. The annual visits should beused as opportunities to provide routinely recommended vac-cine doses, additional catch-up doses needed or lapsed vaccineseries, vaccines recommended or high-risk groups, additionaldoses that might have been recently recommended, and otherrecommended health-care services.

All vaccine doses should be administered according to ACIPvaccine-speciic statements and with the most recent schedulesor both routine and catch-up vaccination. Beore leaving any visit or medical care, adolescents should be encouraged toschedule return visits or any additional vaccine doses needed.During visits that occur outside o inluenza season, providersshould discuss and recommend seasonal inluenza vaccination

and make explicit plans or vaccination, including timing andanticipated setting (e.g., health-care provider’s oice, school, orpharmacy). Catch-up vaccination with multidose adolescentvaccines generally can occur according to the routine dosingschedule or these vaccines, although in some circumstances theclinician or health-care provider might use minimum intervalsor vaccine doses. These circumstances include an outbreak that increases risk or disease or the likelihood that doses willbe missed in the uture (e.g., because o an impending loss o health-care coverage or transportation challenges). Becauseo lack o eicacy data or HPV vaccine administration usingminimum intervals, providers are encouraged, when possible,

to use routine dosing intervals or emales aged 11–26 years who have not yet received 3 HPV vaccine doses as recom-mended ( 20,28 ).

One o the challenges o adolescent vaccination is ensur-ing that current, complete vaccination histories are available.Insurers, covered services, or reimbursement levels can change,and these changes might aect reimbursement or vaccine dosesand vaccination services directly while also causing disruptions

in an adolescent’s access to vaccination providers or venuesIn circumstances in which a vaccination record is unavailablevaccination providers should attempt to obtain this inormation rom various sources (e.g., parent, previous providers, orschool records). More detail about how to obtain these recordsis available at rom CDC at http://www.cdc.gov/vaccines/

recs/immuniz-records.htm. With the exception o inluenzaand pneumococcal polysaccharide vaccines, i documenta-tion o a vaccine dose is not available, the adolescent shouldbe considered unvaccinated or that dose. Regardless o thevenue in which an adolescent receives a dose o vaccine, thatvaccine dose should be documented in the patient’s chart orin an oice log, and the inormation should be entered intoan IIS. The adolescent also should be provided with a recordcard that documents the vaccination history.

Adult Vaccination

The incidence o vaccine-preventable diseases in adults inthe United States is high. Approximately 45,000 adults dieeach year rom vaccine-preventable diseases, the majority rominluenza ( 222 ). In 2008, an estimated 44,000 cases o invasivepneumococcal disease were reported with approximately 4,500deaths, the majority occurring among persons aged >35 years(http://www.cdc.gov/abcs/survreports/spneu08.htm). Becauseo recent licensure o new vaccines approved or adults andnew ACIP recommendations or the use o many vaccinesin adults, providers o adult health care now share a greaterresponsibility or putting these recommendations into practiceIn 2009, an estimated 4,070 deaths were caused by inection

with the HPV strains causing the majority o cervical cancersin this country that are preventable with HPV vaccine androutine Papanicolaou smear testing (http://www.cancer.org/docroot/home/index.asp). Herpes zoster causes considerablemorbidity in adults aged >50 years (55 ). A painul complica-tion o herpes zoster inection is postherpetic neuralgia, whichis characterized by severe pain that can persist or up to a yearater the herpes zoster rash has subsided. A vaccine to prevenherpes zoster was licensed in 2006.

In 2003, the National Vaccine Advisory Committee pub-lished standards or adult vaccination ( 222 ). These standardsinclude ensuring vaccine availability, review o records, com-municating the risks and beneits o vaccination, use o stand-ing orders, and recommending simultaneous administrationo all indicated doses according to the Recommended AdulImmunization Schedule ( 28 ).

Vaccination with vaccines recommended or all adults or orthose in speciic age groups is generally cost-eective, i not cost-saving, or society. The National Commission on PreventionPriorities (NCPP) ranked clinical preventive services based on




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clinically preventable disease eects and cost-eectiveness ( 223).In the NCPP report, inluenza vaccination or adults aged ≥50years and pneumococcal vaccination or adults aged ≥65 yearsranked high, with 8 o 10 possible points in the scoring systemused. Most other studies have ound inluenza vaccination reducesor minimizes health care, societal, and individual costs or the pro-

ductivity losses and absenteeism associated with inluenza illness( 224–226 ). Economic analyses among adults aged ≥65 years haveound inluenza vaccination to be cost-eective ( 225–227 ).

A 2008 study o the cost-eectiveness o PPSV demonstratedthat vaccination resulted in a gain o $3,341 per quality-adjustedlie year; the result is sensitive to vaccine uptake assumptions( 228 ). PPSV administered at ages 50–65 years might be clini-cally avorable and, depending on cost-eectiveness criteria used,economically avorable ( 228 ).

Hepatitis B vaccine is not recommended routinely or alladults. However, multiple studies have established the cost-eectiveness o providing hepatitis B vaccinations at counselingand testing sites or HIV and other sexually transmitted dis-eases, correctional institutions, drug-abuse treatment centers,and other settings serving adults at risk or hepatitis B virusinection ( 229–230 ).

Four studies have estimated the cost-eectiveness o a rou-tine herpes zoster vaccination program o immunocompetentpersons aged ≥60 years ( 231–234 ). At a vaccine cost o $150per dose, the societal costs o routinely vaccinating immu-nocompetent persons aged ≥60 years range rom $27,000 to$112,000 per quality-adjusted lie year gained ( 231–234 ). Theestimated cost per quality-adjusted lie year or zoster vaccina-

tion covers a wide range that appears acceptable compared witheither standard thresholds or other established interventionsbut is at the intermediate to high end o that range.

Vaccination rates in adults are considered suboptimal ( 235– 238 ).Healthy People 2010 goals or adult vaccination coverage withinluenza and pneumococcal polysaccharide vaccines are 90% oreach vaccine. For the 2007–2008 season, inluenza vaccinationcoverage among adults aged 50–64 years was 34%, and cover-age among adults aged ≥65 years was 66% (67 ). In 2008, 60%o adults aged ≥65 years received a dose o PPSV (http://www.cdc.gov/nchs/data/hestat/vaccine_coverage.htm ). New Healthy People 2020 goals or inluenza and pneumococcal polysaccharide

vaccines include speciic subsets o adults, including institutional-ized adults aged ≥18 years (or both inluenza and pneumococcalpolysaccharide vaccines) and noninstitutionalized adults at highrisk aged >18 years (or pneumococcal polysaccharide vaccine)(http://www.healthypeople.gov/hp2020/objectives/topicarea.aspx?id=30&topicarea=immunization+and+inectious+diseases).

The most substantial barrier to vaccination coverage is lack o knowledge about these vaccines among adult patients and adult

providers. Other barriers are cost (lack o additional insuranceto Medicare) ( 239 ) and the lack o inancing mechanisms ornewly licensed and recommended vaccines.

A common challenge or health-care providers is vaccinatingadults with unknown vaccination records. In general (except orinluenza and pneumococcal polysaccharide vaccines), adults

should receive a vaccine dose i the dose is recommended and norecord o previous administration exists. I an adult has a record omilitary service and does not have records available, providers canassume that the person has received all vaccines recommended bythe military at the time o service entry. Serologic testing might behelpul in clariying immune status i questions remain becauseat dierent times and depending on military assignments, theremight be interservice and individual dierences.

Evidence-Based Interventionsto Increase Vaccination Coverage

The independent, nonederal Task Force on CommunityPreventive Services, whose membership is appointed by CDCprovides public health decision-makers with recommenda-tions on population-based interventions to promote healthand prevent disease, injury, disability, and premature deathThe recommendations are based on systematic reviews o thescientiic literature about eectiveness and cost-eectiveness othese interventions. In addition, the task orce identiies criti-cal inormation about the other eects o these interventionsthe applicability to speciic populations and settings, and thepotential barriers to implementation. Additional inormationincluding updates o published reviews, is available rom TheCommunity Guide at http://www.thecommunityguide.org.

Beginning in 1996, the task orce systematically reviewedpublished evidence on the eectiveness and cost-eectiveness opopulation-based interventions to increase coverage o vaccinerecommended or routine use among children, adolescents, andadults. A total o 197 articles were identiied that evaluateda relevant intervention, met inclusion criteria, and were published during 1980–1997. Reviews o 17 speciic interventions were published in 1999 ( 235–238 ). Using the results o theirreview, the task orce made recommendations about the useo these interventions ( 238 ). Several interventions were iden-

tiied and recommended on the basis o published evidenceFollow-up reviews were published in 2000, and a review ointerventions to improve the coverage o adults at high risk was conducted in 2005 ( 238,239 ). The interventions and therecommendations are summarized in this report (Table 15).

In 1997, the task orce categorized as a recommended strat-egy vaccination requirements or child care, school, and college( 236 ). When appropriate, health agencies should take necessarysteps to develop and enorce these requirements.

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A 2008 update o the original task orce systematic review o the evidence on the eectiveness o provider assessment andeedback or increasing coverage rates ound that this strategy remains an eective intervention. A later update reviewed19 new studies published during 1997–2007. The updatedreview supports the original task orce recommendation or

use o assessment and eedback based on strong evidence o eectiveness. The task orce reviewed studies o assessment andeedback as a strategy that were conducted in a range o set-tings, including private practice, managed care, public health,community health settings, and academic centers. Studies haveassessed the eectiveness o this intervention to improve cover-age with MMR, DTP, DTaP, Hib, inluenza, pneumococcal,and Td vaccines ( 237 ). The most updated inormation on thisreview is available at http://www.thecommunityguide.org/vaccines/universally/providerassessment.html. As recognizedby the task orce, routine assessment and eedback o vaccina-tion rates obtained at the provider site is one o the most eec-tive strategies or achieving high, sustainable vaccine coverage.Since 1995, all states receiving ederal unds or vaccinationprograms have been required to conduct annual assessmentso vaccination rates both in public health clinics and in pri-vate provider oices. Primarily to aid local and state healthdepartments in their eorts to conduct assessments and assistproviders, CDC has developed numerous sotware applicationsto measure vaccination rates in provider practices.

Other General Programmatic IssuesProgrammatic challenges, evolving issues, and eective

interventions related to adult and adolescent vaccinationprograms have been described by other advisory groups andexpert groups. Additional evidence-based approaches are beingdeveloped or certain issues (e.g., settings or adolescent vac-cination delivery) through ongoing research and evaluation. Among current programmatic challenges, vaccine inancing isespecially diicult because certain problems and solutions diermarkedly rom one state to another. Practitioners interested inbeginning or continuing to provide vaccinations to patientsare encouraged to consult with local and state public healthvaccination programs to learn about publicly unded programsthat might be available in their areas or patients who need vac-cination but have insuicient health insurance coverage and noinancial resources. I not already participating, providers whocare or adolescents and children aged <19 years should enrollin the Vaccines or Children Program (http://www.cdc.gov/vaccines/programs/vc/deault.htm). Through this program’sprovision o ACIP-recommended, ederally purchased vaccines,participating providers are able to ully vaccinate eligible chil-dren whose parents might not otherwise be able to aord the

vaccinations. Interested providers are encouraged to work withinsurers, state and specialty-speciic medical organizations, vac-cine manuacturers, and other stakeholders to address inanciabarriers to achieving high vaccination coverage. With avail-ability o sae and eective vaccines or 17 vaccine-preventablediseases, the capacity or realizing the potential beneits o these

products in the United States depends on reaching childrenadolescents, and adults through dedicated, knowledgeable vac-cination providers and eicient, strong vaccination programat local, state, and ederal levels.

Vaccine Information SourcesIn addition to these general recommendations, the ollowing

sources contain speciic and updated vaccine inormation.

CDC-INFO Contact Center

The CDC-INFO contact center is supported by CDC andprovides public health-related inormation, including vaccination inormation, or health-care providers and the public, 24hours a day, 7 days a week (telephone [English and Spanish]800-232-4636; telephone [TTY]: 800-232-6348).

CDC’s National Center for Immunizationand Respiratory Diseases

CDC’s National Center or Immunization and RespiratoryDiseases website provides direct access to vaccination recommendations o ACIP, vaccination schedules, automated childschedulers, an adult immunization scheduler, vaccine saety

inormation, publications, provider education and trainingand links to other vaccination-related websites (http://wwwcdc.gov/vaccines).

MMWR

ACIP recommendations regarding vaccine use, statementso vaccine policy as they are developed, and reports o speciicdisease activity are published by CDC in the MMWR series andcan be ound at http://www.cdc.gov/vaccines/pubs/ACIP-listhtm. Electronic subscriptions are ree (http://www.cdc.gov/mmwr/mmwrsubscribe.html). Subscriptions to print versionsalso are available rom the Superintendent o Documents, U.S

Government Printing Oice, Washington, D.C. 20402-9235(telephone: 202-512-1800).

American Academy of Pediatrics (AAP)

Every 3 years, AAP issues the Red Book: Report of theCommittee on Infectious Diseases , which contains a compositesummary o AAP and ACIP recommendations concerninginectious diseases and vaccinations or inants, children, and

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adolescents (telephone: 888-227-1770; website: http://www.aap.org).

American Academy of Family Physicians (AAFP)

Inormation rom the proessional organization o amily physicians is available at http://www.aap.org.

Immunization Action Coalition

The Immunization Action Coalition provides extensive reeprovider and patient inormation, including translations o VISs into multiple languages. Printed materials are reviewedby CDC or technical accuracy (http://www.immunize.org and http://www.vaccineinormation.org).

National Network for Immunization Information

This National Network or Immunization Inormation isan ailiation o the Inectious Diseases Society o America,the Pediatric Inectious Diseases Society, AAP, the American

Nurses Association, AAFP, the National Association o Pediatric Nurse Practitioners, the American College o Obstetricians and Gynecologists, the University o TexasMedical Branch, the Society or Adolescent Medicine, andthe American Medical Association. This source provides thepublic, health proessionals, policy makers, and the media with up-to-date, scientiically valid inormation (http://www.immunizationino.org).

Vaccine Education Center

Located at the Children’s Hospital o Philadelphia, theVaccine Education Center provides patient and provider vac-

cine inormation (http://www.vaccine.chop.edu).

Institute for Vaccine Safety

Located at Johns Hopkins University School o PublicHealth, the Institute or Vaccine Saety provides inormationabout vaccine saety concerns and objective and timely inormation to physicians and health-care providers and parents(http://www.vaccinesaety.edu).

Group on Immunization Education of the Societyof Teachers of Family Medicine

The Group on Immunization Education o the Society oTeachers o Family Medicine provides inormation or clini-cians, including the ree program Shots. Shots includes thechildhood, adolescent, and adult schedules or iPhone, Palmand Windows devices, as well as online versions (http://wwwimmunizationed.org).

State and Local Health Departments

State and local health departments provide technical advicethrough hotlines, e-mail, and websites, including printedinormation regarding vaccines and immunization schedulesposters, and other educational materials.

Acknowledgments

The members o the Advisory Committee on ImmunizationPractices are grateul or the contributions o Doug Campos-Outcalt MD, University o Arizona College o MedicinePhoenix, Arizona; Patricia Stinchield, MS, Nationa Association o Pediatric Nurse Practitioners, Cherry Hill, New Jersey; and Christine Robinette Curtis, MD, Shannon Stokely

MPH, and Gregory Wallace, MD, CDC, Atlanta, Georgia.

http://www.aap.org/

http://www.aap.org/

http://www.aafp.org/


http://www.vaccineinformation.org/

http://www.immunizationinfo.org/


http://www.vaccine.chop.edu/

http://www.vaccinesafety.edu/

http://www.immunizationed.org/




http://www.vaccinesafety.edu/

http://www.vaccine.chop.edu/



http://www.vaccineinformation.org/


http://www.aafp.org/

http://www.aap.org/

http://www.aap.org/

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TABLE 1. Recommended and minimum ages and intervals between vaccine doses*†

Vaccine and dose numberRecommended

age for this dose Minimum age for this doseRecommended

interval to next dose Minimum interval to next dose

HepB-1§ Birth Birth 1–4 months 4 weeks

HepB-2 1–2 months 4 weeks 2–17 months 8 weeks

HepB-3¶ 6–18 months 24 weeks — —

DTaP-1§ 2 months 6 weeks 2 months 4 weeks

DTaP-2 4 months 10 weeks 2 months 4 weeksDTaP-3 6 months 14 weeks 6–12 months 6 months**,††

DTaP-4 15–18 months 12 months 3 years 6 months**

DTaP-5 4–6 years 4 years — —

Hib-1§,§§ 2 months 6 weeks 2 months 4 weeks

Hib-2 4 months 10 weeks 2 months 4 weeks

Hib-3¶¶ 6 months 14 weeks 6–9 months 8 weeks

Hib-4 12–15 months 12 months — —

IPV-1§ 2 months 6 weeks 2 months 4 weeks

IPV-2 4 months 10 weeks 2–14 months 4 weeks

IPV-3 6–18 months 14 weeks 3–5 years 6 months

IPV-4*** 4–6 years 4 years — —

PCV-1§§ 2 months 6 weeks 8 weeks 4 weeks

PCV-2 4 months 10 weeks 8 weeks 4 weeks

PCV-3 6 months 14 weeks 6 months 8 weeks

PCV-4 12–15 months 12 months — —MMR-1††† 12–15 months 12 months 3–5 years 4 weeks

MMR-2††† 4–6 years 13 months — —

Varicella-1††† 12–15 months 12 months 3–5 years 12 weeks§§§

Varicella-2††† 4–6 years 15 months — —

HepA-1 12–23 months 12 months 6–18 months** 6 months**

HepA-2 ≥18 months 18 months — —

Inluenza, inactivated¶¶¶ ≥6 months 6 months**** 1 month 4 weeks

LAIV (intranasal)¶¶¶ 2–49 years 2 years 1 month 4 weeks

MCV4-1†††† 11–12 years 2 years 5 years 8 weeks

MCV4-2 16 years 11 years (+8 weeks) — —

MPSV4-1†††† — 2 years 5 years 5 years

MPSV4-2 — 7 years — —

Td 11–12 years 7 years 10 years 5 years

Tdap§§§§ ≥11 years 7 years — —

PPSV-1 — 2 years 5 years 5 years

PPSV-2¶¶¶¶ — 7 years — —

HPV-1***** 11–12 years 9 years 2 months 4 weeks

HPV-2 11–12 years (+2 months) 9 years (+4 weeks) 4 months 12 weeks†††††

HPV-3††††† 11–12 years (+6 months) 9 years (+24 weeks) — —

Rotavirus-1§§§§§ 2 months 6 weeks 2 months 4 weeks

Rotavirus-2 4 months 10 weeks 2 months 4 weeks

Rotavirus-3¶¶¶¶¶ 6 months 14 weeks — —Herpes zoster****** ≥60 years 60 years — —

See table ootnotes on page 37

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TABLE 1. (Continued ) Recommended and minimum ages and intervals between vaccine doses*,†

Abbreviations: DTaP = diphtheria and tetanus toxoids and acellular pertussis; HepA = hepatitis A; HepB = hepatitis B; Hib = Haemophilus influenzae type b; HPV =human papillomavirus; IPV = inactivated poliovirus; LAIV = live, attenuated inluenza vaccine; MCV4 = quadrivalent meningococcal conjugate vaccine; MMR = measlesmumps, and rubella; MMRV = measles, mumps, rubella, and varicella; MPSV4 = quadrivalent meningococcal polysaccharide vaccine; PCV = pneumococcal conjugatvaccine; PPSV = pneumococcal polysaccharide vaccine; PRP-OMB = polyribosylribitol phosphate-meningococcal outer membrane protein conjugate; Td = tetanuand diphtheria toxoids; TIV = trivalent inactiated inluenza vaccine; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis; Var = varicella vaccine

* Combination vaccines are available. Use o licensed combination vaccines is generally preerred to separate injections o their equivalent component vaccinesWhen administering combination vaccines, the minimum age or administration is the oldest age or any o the individual components; the minimum interva

between doses is equal to the greatest interval o any o the individual components.† Inormation on travel vaccines, including typhoid, Japanese encephalitis, and yellow ever, is available at http://www.cdc.gov/travel . Inormation on other vaccine

that are licensed in the United States but not distributed, including anthrax and smallpox, is available at http://www.bt.cdc.gov.§ Combination vaccines containing the hepatitis B component are available (see Table 2). These vaccines should not be administered to inants aged <6 week

because o the other components (i.e., Hib, DTaP, HepA, and IPV).¶ HepB-3 should be administered at least 8 weeks ater HepB-2 and at least 16 weeks ater HepB-1 and should not be administered beore age 24 weeks.

** Calendar months.†† The minimum recommended interval between DTaP-3 and DTaP-4 is 6 months. However, DTaP-4 need not be repeated i administered at least 4 months ater DTaP-3.§§ For Hib and PCV, children receiving the irst dose o vaccine at age ≥7 months require ewer doses to complete the series.¶¶ I PRP-OMP (Pedvax-Hib, Merck Vaccine Division) was administered at ages 2 and 4 months, a dose at age 6 months is not necessary.

*** A ourth dose is not needed i the third dose was administered at ≥4 years and at least 6 months ater the previous dose.††† Combination MMRV vaccine can be used or children aged 12 months–12 years. See text or details.§§§ The minimum interval rom Varicella-1 to Varicella-2 or persons beginning the series at age ≥13 years is 4 weeks.¶¶¶ One dose o inluenza vaccine per season is recommended or most persons. Children aged <9 years who are receiving inluenza vaccine or the irst time o

who received only 1 dose the previous season (i it was their irst vaccination season) should receive 2 doses this season.**** The minimum age or inactivated inluenza vaccine varies by vaccine manuacturer. See package insert or vaccine-speciic minimum ages.†††† Revaccination with meningococcal vaccine is recommended or previously vaccinated persons who remain at high risk or meningococcal disease. (Source

CDC. Updated recommendations rom the Advisory Committee on Immunization Practices (ACIP) or revaccination o persons at prolonged increased risk omeningococcal disease. MMWR 2009;58:[1042–3]).

§§§§ Only 1 dose o Tdap is recommended. Subsequent doses should be given as Td. For one brand o Tdap, the minimum age is 11 years. For management o atetanus-prone wound in persons who have received a primary series o tetanus-toxoid–containing vaccine, the minimum interval ater a previous dose o anytetanus-containing vaccine is 5 years.

¶¶¶¶ A second dose o PPSV 5 years ater the irst dose is is recommended or persons aged ≤65 years at highest risk or serious pneumococcal inection and thoswho are likely to have a rapid decline in pneumococcal antibody concentration. (Source: CDC. Prevention o pneumococcal disease: recommendations o theAdvisory Committee on Immunization Practices [ACIP]. MMWR 1997;46[No. RR-8]).

***** Bivalent HPV vaccine is approved or emales aged 10–25 years. Quadrivalent HPV vaccine is approved or males and emales aged 9–26 years.††††† The minimum age or HPV-3 is based on the baseline minimum age or the irst dose (i.e., 108 months) and the minimum interval o 24 weeks between th

irst and third dose. Dose 3 need not be repeated i it is administered at least 16 weeks ater the irst dose.§§§§§ The irst dose o rotavirus must be administered at age 6 weeks through 14 weeks and 6 days. The vaccine series should not be started or inants aged ≥15

weeks, 0 days. Rotavirus should not be administered to children older than 8 months, 0 days o age regardless o the number o doses received between weeks and 8 months, 0 days o age.

¶¶¶¶¶ I 2 doses o Rotarix (GlaxoSmithKline) are administered as age appropriate, a third dose is not necessary.****** Herpes zoster vaccine is recommended as a single dose or persons aged ≥60 years.

TABLE 2. FDA-licensed combination vaccines*

Vaccine† Trade name (year licensed) Age range Routinely recommended ages

Hib-HepB Comvax (1996) 6 weeks–71 months Three-dose schedule at 2, 4, and 12–15 months o ageDTaP/Hib TriHIBit (1996) 15–18 months Fourth dose o Hib and DTaP series

HepA-HepB Twinrix (2001) ≥18 years Three doses on a schedule o 0, 1, and 6 months

DTaP-HepB-IPV Pediarix (2002) 6 weeks–6 years Three-dose series at 2, 4 and 6 months o ageMMRV ProQuad (2005) 12 months–12 years Two doses, the irst at 12–15 months, the second at 4–6 years

DTaP-IPV Kinrix (2008) 4–6 years Fith dose o DTaP and ourth dose o IPV

DTaP-IPV/Hib Pentacel (2008) 6 weeks–4 years Four-dose schedule at 2, 4, 6, and 15–18 months o age

Abbreviations: DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; FDA = Food and Drug Administration; HepA =hepatitis A; HepB = hepatitis B; Hib = Haemophilus influenzae type b; IPV = inactivated poliovirus; MMR = measles, mumps, and rubella; MMRV = measles, mumpsrubella, and varicella; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.

Source: American Academy o Pediatrics. Passive immunization. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS, eds. Red book: 2009 report o the Committee onInectious Diseases. 28th ed. Elk Grove Village, IL: American Academy o Pediatrics; 2009.* Although MMR, DTaP, DT, Td, and Tdap are combination vaccines, they are not included on this list because they are not available in the United States as single-antigen

products.† A dash ( - ) between vaccine products indicates that products are supplied in their inal orm by the manuacturer and do not require mixing or reconstitution by

the user. A slash ( / ) indicates that the products must be mixed or reconstituted by the user.

http://www.cdc.gov/travel

http://www.bt.cdc.gov/

http://www.bt.cdc.gov/

http://www.cdc.gov/travel

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TABLE 4. Guidelines for administering antibody-containing products* and vaccines

Type of administration Products administered Recommended minimum interval between doses

Simultaneous (duringthe same oice visit)

Antibody-containing products and inactivated antigen Can be administered simultaneously at dierent anatomic siteor at any time interval between doses

Antibody-containing products and live antigen Should not be administered simultaneously.† I simultaneousadministration o measles-containing vaccine or varicella

vaccine is unavoidable, administer at dierent sites andrevaccinate or test or seroconversion ater the recommend-ed interval (see Table 5)

Nonsimultaneous Administered first Administered second

Antibody-containing products Inactivated antigen No interval necessary

Inactivated antigen Antibody-containing products No interval necessaryAntibody-containing products Live antigen Dose related†,§

Live antigen Antibody-containing products 2 weeks†

* Blood products containing substantial amounts o immune globulin include intramuscular and intravenous immune globulin, speciic hyperimmune globulin (e.ghepatitis B immune globulin, tetanus immune globulin, varicella zoster immune globulin, and rabies immune globulin), whole blood, packed red blood cells, plasmaand platelet products.

† Yellow ever vaccine; rotavirus vaccine; oral Ty21a typhoid vaccine; live, attenuated inluenza vaccine; and zoster vaccine are exceptions to these recommendations These live, attenuated vaccines can be administered at any time beore or ater or simultaneously with an antibody-containing product.

§ The duration o intererence o antibody-containing products with the immune response to the measles component o measles-containing vaccine, and possibly

varicella vaccine, is dose related (see Table 5).

TABLE 3. Guidelines for spacing of live and inactivated antigens

Antigen combination Recommended minimum interval between doses

Two or more inactivated* May be administered simultaneously or at any interval between dosesInactivated and live May be administered simultaneously or at any interval between doses

Two or more live injectable† 28 days minimum interval, i not administered simultaneously

Source: American Academy o Pediatrics. Pertussis. In: Pickering LK, Baker, CJ, Kimberlin DW, Long SS, eds. Red book: 2009 report o the Committee on InectiousDiseases. 28th ed. Elk Grove Village, IL: American Academy o Pediatrics; 2009:22.* Certain experts suggest a 28-day interval between tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine and tetravalent meningococca

conjugate vaccine i they are not administered simultaneously.† Live oral vaccines (e.g., Ty21a typhoid vaccine and rotavirus vaccine) may be administered simultaneously or at any interval beore or ater inactivated or live inject

able vaccines.

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TABLE 5. Recommended intervals between administration of antibody-containing products and measles- or varicella-containing vaccine, byproduct and indication for vaccination

Product/Indication Dose (mg IgG/kg) and route*

Recommended interval beforemeasles- or varicella-containing

vaccine† administration (months)

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

Hepatitis A IG

Contact prophylaxis 0.02 mL/kg (3.3 mg IgG/kg) IM 3International travel 0.06 mL/kg (10 mg IgG/kg) IM 3

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

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

Varicella IG 125 units/10 kg (60–200 mg IgG/kg) IM, maximum 625 units 5

Measles prophylaxis IG

Standard (i.e., nonimmunocompromised) contact 0.25 mL/kg (40 mg IgG/kg) IM 5

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

Blood transfusionRBCs, washed 10 mL/kg, negligible IgG/kg IV None

RBCs, adenine-saline added 10 mL/kg (10 mg IgG/kg) IV 3

Packed RBCs (hematocrit 65%)§ 10 mL/kg (60 mg IgG/kg) IV 6Whole blood (hematocrit 35%–50%)§ 10 mL/kg (80–100 mg IgG/kg) IV 6

Plasma/platelet products 10 mL/kg (160 mg IgG/kg) IV 7

Cytomegalovirus IGIV 150 mg/kg maximum 6IGIV

Replacement therapy or immune deiciencies¶ 300–400 mg/kg IV¶ 8Immune thrombocytopenic purpura treatment 400 mg/kg IV 8

Postexposure varicella prophylaxis** 400 mg/kg IV 8

Immune thrombocytopenic purpura treatment 1000 mg/kg IV 10

Kawasaki disease 2 g/kg IV 11

Monoclonal antibody to respiratory syncytial virusF protein (Synagis [MedImmune])††

15 mg/kg IM None

Abbreviations:HIV = human immunodeiciency virus; IG = immune globulin; IgG = immune globulin G; IGIV = intravenous immune globulin; mg IgG/kg = milligramo immune globulin G per kilogram o body weight; IM = intramuscular; IV = intravenous; RBCs = red blood cells.* This table is not intended or determining the correct indications and dosages or using antibody-containing products. Unvaccinated persons might not be pro

tected ully against measles during the entire recommended interval, and additional doses o IG or measles vaccine might be indicated ater measles exposureConcentrations o measles antibody in an IG preparation can vary by manuacturer’s lot. Rates o antibody clearance ater receipt o an IG preparation also mighvary. Recommended intervals are extrapolated rom an estimated hal-lie o 30 days or passively acquired antibody and an observed intererence with the immune response to measles vaccine or 5 months ater a dose o 80 mg IgG/kg.

† Does not include zoster vaccine. Zoster vaccine may be given with antibody-containing blood products. § Assumes a serum IgG concentration o 16 mg/mL. ¶ Measles and varicella vaccinations are recommended or children with asymptomatic or mildly symptomatic HIV inection but are contraindicated or persons with

severe immunosuppression rom HIV or any other immunosuppressive disorder.** The investigational VariZIG, similar to licensed varicella-zoster IG (VZIG), is a puriied human IG preparation made rom plasma containing high levels o antivaricella

antibodies (IgG). The interval between VariZIG and varicella vaccine (Var or MMRV) is 5 months. †† Contains antibody only to respiratory syncytial virus

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TABLE 6. Contraindications and precautions* to commonly used vaccines

Vaccine Contraindications Precautions

DTaP Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

Encephalopathy (e.g., coma, decreased level o conscious-ness, or prolonged seizures), not attributable to anotheridentiiable cause, within 7 days o administration o

previous dose o DTP or DTaP

Progressive neurologic disorder, including inantile spasms, uncontrolled epilepsy,progressive encephalopathy; deer DTaP until neurologic status clariied andstabilized

Temperature o ≥105°F (≥40.5°C) within 48 hours ater vaccination with a previousdose o DTP or DTaP

Collapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hoursater receiving a previous dose o DTP/DTaPSeizure ≤3 days ater receiving a previous dose o DTP/DTaPPersistent, inconsolable crying lasting ≥3 hours within 48 hours ater receiving a

previous dose o DTP/DTaPGBS <6 weeks ater previous dose o tetanus toxoid–containing vaccineHistory o arthus-type hypersensitivity reactions ater a previous dose o tetanus

toxoid–containing vaccine; deer vaccination until at least 10 years have elapsedsince the last tetanus toxoid–containing vaccine

Moderate or severe acute illness with or without ever

DT, Td Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

GBS <6 weeks ater previous dose o tetanus toxoid–containing vaccineHistory o arthus-type hypersensitivity reactions ater a previous dose o tetanus

toxoid–containing vaccine; deer vaccination until at least 10 years have elapsedsince the last tetanus-toxoid-containing vaccine


Tdap Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine componentEncephalopathy (e.g., coma, decreased level o conscious-

ness, or prolonged seizures), not attributable to anotheridentiiable cause, within 7 days o administration o previous dose o DTP, DTaP, or Tdap

GBS <6 weeks ater a previous dose o tetanus toxoid–containing vaccineProgressive or unstable neurological disorder, uncontrolled seizures, or progressiveencephalopathy until a treatment regimen has been established and the conditionhas stabilized

History o arthus-type hypersensitivity reactions ater a previous dose o tetanustoxoid–containing vaccine; deer vaccination until at least 10 years have elapsedsince the last tetanus toxoid–containing vaccine


IPV Severe al lergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

PregnancyModerate or severe acute illness with or without ever

MMR†,§ Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

PregnancyKnown severe immunodeiciency (e.g., rom hematologic

and solid tumors, receipt o chemotherapy, congenital

immunodeiciency, or long-term immunosuppressivetherapy¶ or patients with HIV inection who are severelyimmunocompromised) §

Recent (≤11 months) receipt o antibody-containing blood product (speciic intervaldepends on product)**

History o thrombocytopenia or thrombocytopenic purpuraNeed or tuberculin skin testing††


Hib Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

Age <6 weeks


Hepatitis B Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

Inant weight <2,000 gm§§


Hepatitis A Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component


Varicella Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

Known severe immunodeiciency (e.g., rom hematologic

and solid tumors, receipt o chemotherapy, congenitalimmunodeiciency, or long-term immunosuppressivetherapy¶ or patients with HIV inection who are severelyimmunocompromised) §

Pregnancy

Recent (≤11 months) receipt o antibody-containing blood product (speciic intervaldepends on product)¶¶


See table ootnotes on page 41

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TABLE 6. (Continued ) Contraindications and precautions* to commonly used vaccines

Vaccine Contraindications Precautions

PCV Severe allergic reaction (e.g., anaphylaxis) ater a previousdose (o PCV7, PCV13, or any diphtheria toxoid–contain-ing vaccine) or to a component o a vaccine (PCV7, PCV13,or any diphtheria toxoid–containing vaccine)


TIV Severe allergic reaction (e.g., anaphylaxis) ater previousdose or to vaccine component, including egg protein GBS <6 weeks ater a previous dose o inluenza vaccineModerate or severe acute illness with or without ever

LAIV Severe allergic reaction (e.g., anaphylaxis) ater previousdose or to vaccine component, including egg protein

PregnancyImmunosuppressionCertain chronic medical conditions***

GBS <6 weeks ater a previous dose o inluenza vaccineModerate o severe acute illness with or without ever

PPSV Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component


MCV4 Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component


MPSV4 Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component


HPV Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component


Rotavirus Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

SCID

Altered immunocompetence other than SCIDHistory o intussusceptionChronic gastrointestinal disease†††

Spina biida or bladder exstrophy†††


Zoster Severe allergic reaction (e.g., anaphylaxis) ater a previousdose or to a vaccine component

Substantial suppression o cellular immunityPregnancy


Abbreviations:DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; GBS = Guillian-Barré syndrome; HBsAg = hepatitiB surace antigen; Hib = Haemophilus influenzae type b; HIV = human immunodeiciency virus; HPV = human papillomavirus; IPV = inactivated poliovirus; LAIV = live

attenuated inluenza vaccine; MCV4 = quadrivalent meningococcal conjugate vaccine; MMRV = measles, mumps, rubella, and varicella; MPSV4 = quadrivalent meningococcal polysaccharide vaccine; PCV = pneumococcal conjugate vaccine; PPSV = pneumococcal polysaccharide vaccine; SCID = severe combined immunodeiciency

Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis; TIV = trivalent inactivated inluenza vaccine.* Events or conditions listed as precautions should be reviewed careully. Beneits o and r isks or administering a speciic vaccine to a person under these circum

stances should be considered. I the r isk rom the vaccine is believed to outweigh the beneit, the vaccine should not be administered. I the beneit o vaccinationis believed to outweigh the risk, the vaccine should be administered. Whether and when to administer DTaP to children with proven or suspected underlyingneurologic disorders should be decided on a case-by-case basis.

† HIV-inected children may receive varicella and measles vaccine i CD4+ T-lymphocyte count is >15%. (Source: Adapted rom American Academy o PediatricsPassive immunization. In: Pickering LK, ed. Red book: 2009 report o the committee on inectious diseases. 28th ed. Elk Grove Village, IL: American Academy oPediatrics: 2009.)

§ MMR and varicella vaccines can be administered on the same day. I not administered on the same day, these vaccines should be separated by at least 28 days. ¶ Substantially immunosuppressive steroid dose is considered to be ≥2 weeks o daily receipt o 20 mg or 2 mg/kg body weight o prednisone or equivalent.** See text and Table 5 or details.

†† Measles vaccination might suppress tuberculin reactivity temporarily. Measles-containing vaccine can be administered on the same day as tuberculin skin testingI testing cannot be perormed until ater the day o MMR vaccination, the test should be postponed or ≥4 weeks ater the vaccination. I an urgent need existto skin test, do so with the understanding that reactivity might be reduced by the vaccine.

§§ Hepatitis B vaccination should be deerred or inants weighing <2,000 g i the mother is documented to be HBsAg-negative at the time o the inant’s birth

Vaccination can commence at chronological age 1 month or at hospital discharge. For inants born to HBsAg-positive women, hepatitis B immune globulin andhepatitis B vaccine should be administered within 12 hours ater birth, regardless o weight.

¶¶ Vaccine should be deerred or the appropriate interval i replacement immune globulin products are being administered (see Table 5). *** Source: CDC. Prevention and control o seasonal inluenza with vaccines: recommendations o the Advisory Committee on Immunization Practices (ACIP), 2010

MMWR 2010;59(No. RR-8). ††† For details, see CDC. Prevention o rotavirus gastroenteritis among inants and children: recommendations o the Advisory Committee on Immunization Practices

MMWR 2009;58(No. RR-2).

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TABLE 7. Conditions commonly misperceived as contraindications to vaccination

VaccineConditions commonly misperceived as contraindications

(i.e., vaccination may be administered under these conditions)

General or all vaccines, includingDTaP, pediatric DT, adult Td,adolescent-adult Tdap, IPV, MMR,Hib, hepatitis A, hepatitis B,

varicella, rotavirus, PCV, TIV, LAIV,PPSV, MCV4, MPSV4, HPV, andherpes zoster

Mild acute illness with or without everMild-to-moderate local reaction (i.e., swelling, redness, soreness); low-grade or moderate ever ater previous doseLack o previous physical examination in well-appearing personCurrent antimicrobial therapy*

Convalescent phase o illnessPreterm birth (hepatitis B vaccine is an exception in certain circumstances)†

Recent exposure to an inectious diseaseHistory o penicillin allergy, other nonvaccine allergies, relatives with allergies, or receiving allergen extract immunotherapy

DTaP Fever o <105°F (<40.5°C), ussiness or mild drowsiness ater a previous dose o DTP/DTaPFamily history o seizuresFamily history o sudden inant death syndromeFamily history o an adverse event ater DTP or DTaP administrationStable neurologic conditions (e.g., cerebral palsy, well-controlled seizures, or developmental delay)

Tdap Fever o ≥105°F (≥40.5°C) or <48 hours ater vaccination with a previous dose o DTP or DTaPCollapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hours ater receiving a previous dose o DTP

DTaPSeizure <3 days ater receiving a previous dose o DTP/DTaPPersistent, inconsolable crying lasting >3 hours within 48 hours ater receiving a previous dose o DTP/DTaPHistory o extensive limb swelling ater DTP/DTaP/Td that is not an arthus-type reaction

Stable neurologic disorderHistory o brachial neuritisLatex allergy that is not anaphylacticBreasteedingImmunosuppression

IPV Previous receipt o ≥1 dose o oral polio vaccine

MMR§,¶ Positive tuberculin skin testSimultaneous tuberculin skin testing**BreasteedingPregnancy o recipient’s mother or other close or household contactRecipient is emale o child-bearing ageImmunodeicient amily member or household contactAsymptomatic or mildly symptomatic HIV inectionAllergy to eggs

Hepatitis B PregnancyAutoimmune disease (e.g., systemic lupus erythematosis or rheumatoid arthritis)

Varicella Pregnancy o recipient’s mother or other close or household contactImmunodeicient amily member or household contact††

Asymptomatic or mildly symptomatic HIV inectionHumoral immunodeiciency (e.g., agammaglobulinemia)

TIV Nonsevere (e.g., contact) allergy to latex, thimerosal, or eggConcurrent administration o coumadin or aminophylline

LAIV Health-care providers that see patients with chronic diseases or altered immunocompetence (an exception is providers orseverely immunocompromised patients requiring care in a protected environment)

BreasteedingContacts o persons with chronic disease or altered immunocompetence (an exception is contacts o severely immunocom-

promised patients requiring care in a protected environment)

PPSV History o invasive pneumococcal disease or pneumonia

HPV ImmunosuppressionPrevious equivocal or abnormal Papanicolaou testKnown HPV inectionBreasteedingHistory o genital warts

See table ootnotes on page 43.

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TABLE 7. (Continued ) Conditions commonly misperceived as contraindications to vaccination

VaccineConditions commonly misperceived as contraindications

(i.e., vaccination may be administered under these conditions)

Rotavirus PrematurityImmunosuppressed household contactsPregnant household contacts

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) or treatment o rheumatoid arthritis, psoriasis, polymyositis, sarcoidosis, inlammatory boweldisease, or other conditions

Health-care providers o patients with chronic diseases or altered immunocompetenceContacts o patients with chronic diseases or altered immunocompetenceUnknown or uncertain history o 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 acellulapertussis; HBsAg = hepatitis B surace antigen; Hib = Haemophilus influenzae type b; HPV = human papillomavirus; IPV = inactivated poliovirus; LAIV = live, attenuatedinluenza vaccine; MCV4 = quadrivalent meningococcal conjugate vaccine; MMR = measles, mumps, and rubella; MPSV4 = quadrivalent meningococcal polysaccharidevaccine; PCV = pneumococcal conjugate vaccine; PPSV = pneumococcal polysaccharide vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduceddiphtheria toxoid, and acellular pertussis; TIV = trivalent inactivated inluenza vaccine.

* Antibacterial drugs might interere with Ty21a oral typhoid vaccine, and certain antiviral drugs might interere with varicella-containing vaccines and LAIV. † Hepatitis B vaccination should be deerred or inants weighing <2,000 g i the mother is documented to be HBsAg-negative at the time o the inant’s birth

Vaccination can commence at chronological age 1 month or at hospital discharge. For inants born to HBsAg-positive women, hepatitis B immune globulin andhepatitis B vaccine should be administered within 12 hours ater birth, regardless o weight.

§ MMR and varicella vaccines can be administered on the same day. I not administered on the same day, these vaccines should be separated by at least 28 days.

¶ HIV-inected children should receive immune globulin ater exposure to measles. HIV-inected children can receive varicella and measles vaccine i CD4+T-lymphocytecount is >15%. (Source: Adapted rom American Academy o Pediatrics. Passive immunization. In: Pickering LK, ed. Red book: 2009 report o the Committee onInectious Diseases. 28th ed. Elk Grove Village, IL: American Academy o Pediatrics; 2009.)

** Measles vaccination might suppress tuberculin reactivity temporarily. Measles-containing vaccine can be administered on the same day as tuberculin skin testingI testing cannot be perormed until ater the day o MMR vaccination, the test should be postponed or at least 4 weeks ater the vaccination. I an urgent needexists to skin test, do so with the understanding that reactivity might be reduced by the vaccine.

†† I a vaccinee experiences a presumed vaccine-related rash 7–25 days ater vaccination, the person should avoid direct contact with immunocompromised personor the duration o the rash.

TABLE 8. Treatment of anaphylaxis in children and adults with drugs administered intramuscularly or orally

Drug Dosage

Children

Primary regimen

Epinephrine 1:1000 (aqueous) (1 mg/mL)* 0.01 mg/kg up to 0.5 mg (administer 0.01 mL/kg/dose up to 0.5 mL) IM repeated every 10–20 minutesup to 3 doses

Secondary regimen

Diphenhydramine 1–2 mg/kg oral, IM, or IV, every 4–6 hours (100 mg, maximum single dose)

Hydroxyzine 0.5–1 mg/kg oral, IM, every 4–6 hours (100 mg, maximum single dose)Prednisone 1.5–2 mg/kg oral (60 mg, maximum single dose); use corticosteroids as long as needed

Adults

Primary regimen

Epinephrine 1:1000 (aqueous)* 0.01 mg/kg up to 0.5 mg (administer 0.01 mL/kg/dose up to 0.5 mL) IM repeated every 10–20 minutesup to 3 doses

Secondary regimenDiphenhydramine 1–2 mg/kg up to 100 mg IM or oral, every 4–6 hours

Abbreviations: IM = intramuscular; IV = intravenous.Sources: Adapted rom American Academy o Pediatrics. Passive immunization. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS. Red book: 2009 report o theCommittee on Inectious Diseases. 28th ed. Elk Grove Village, IL: American Academy o Pediatrics, 2009:66–7; Immunization Action Coalition. Medical managemeno vaccine reactions in adult patients (available at www.immunize.org/catg.d/p3082.pd); and Mosby’s Drug Consult. St. Louis, MO: Elsevier; 2005.* I the agent causing the anaphylactic reaction was administered by injection, epinephrine may be injected into the same site to slow absorption.

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TABLE 9. Dose and route of administration for selected vaccines

Vaccine Dose Route

DTaP, DT, Td, Tdap 0.5 mL IM

DTaP-HepB-IPV 0.5 mL IM

DTaP/Hib 0.5 mL IM

DTaP-IPV/Hib 0.5 mL IM

DTaP-IPV 0.5 mL IM

Hib 0.5 mL IM

Combination Hib/HepB 0.5 mL IM

HepA ≤18 years: 0.5 mL≥19 years: 1.0 mL

IM

HepB ≤19 years: 0.5 mL*≥20 years: 1.0 mL

IM

HepA-HepB ≥18 years: 1.0 mL IM

LAIV 0.2 mL divided dose between nares Intranasal spray

TIV 6–35 months: 0.25 mL≥3 years: 0.5 mL

IM

MMR 0.5 mL SC

MMRV 0.5 mL SC

MCV4 0.5 mL IMMPSV4 0.5 mL SC

PCV 0.5 mL IM

PPSV 0.5 mL IM or SC

HPV (HPV2 or HPV4) 0.5 mL IM

IPV 0.5 mL IM or SC

Rotavirus (RV1 or RV5) (1.0 mL or 2.0 mL) Oral

Varicella 0.5 mL SC

Herpes zoster 0.65 mL SC

Abbreviations: DT = diphtheria and tetanus toxoids; DTP = diphtheria toxoid, tetanus toxoid,and pertussis; DTaP = diphtheria and tetanus toxoids and acellular pertussis; HepA = hepatitisA; HepB = hepatitis B; Hib = Haemophilus influenzae type b; HPV = human papillomavirus;HPV2 = bivalent HPV vaccine; HPV4 = quadrivalent HPV vaccine; IM = intramuscular; IPV =inactivated poliovirus; LAIV = live, attenuated inluenza vaccine; MCV4 = quadrivalent menin-gococcal conjugate vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps,

rubella, and varicella; MPSV4 = quadrivalent meningococcal polysaccharide vaccine; PCV =pneumococcal conjugate vaccine; PPSV = pneumococcal polysaccharide vaccine; SC = sub-cutaneous; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheriatoxoid, and acellular pertussis; TIV = trivalent inactivated inluenza vaccine.Source: Adapted rom Immunization Action Coalition: http://www.immunize.org.* Persons aged 11–15 years may be administered Recombivax HB (Merck), 1.0 mL (adult

ormulation) on a 2-dose schedule.



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TABLE 10. Needle length and injection site of IM injections for children aged ≤18 years(by age) and adults aged ≥19 years (by sex and weight)

Age group Needle length Injection site

Children (birth–18 yrs)Neonates* 5 /8 inch (16 mm)† Anterolateral thigh

Inants, 1–12 mos 1 inch (25 mm) Anterolateral thigh

Toddlers, 1–2 yrs 1–1 1 /4 inch (25–32 mm) Anterolateral thigh§

5 /8†–1 inch (16–25 mm) Deltoid muscle o arm

Children, 3–18 yrs 5 /8†–1 inch (16–25 mm) Deltoid muscle o arm§

1–11 /4 inches (25–32 mm) Anterolateral thigh

Adults (≥19 yrs)Men and women, <60 kg (130 lbs) 1 inch (25 mm)¶ Deltoid muscle o armMen and women, 60–70 kg (130–152 lbs) 1 inch (25 mm)Men, 70–118 kg (152–260 lbs) 1–11 /2 inches (25–38 mm)Women, 70–90 kg (152–200 lbs)Men, >118 kg (260 lbs) 11 /2 inches (38 mm)Women, >90 kg (200 lbs)

Abbreviation: IM = intramuscular.Source: Adapted rom Poland GA, Borrud A, Jacobsen RM, et al. Determination o deltoid at pad thickness:implications or needle length in adult immunization. JAMA 1997;277:1709–11.* First 28 days o lie.

† I skin is stretched tightly and subcutaneous tissues are not bunched.§ Preerred site.¶ Some experts recommend a 5 /8-inch needle or men and women who weigh <60 kg.

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TABLE 11. Vaccine storage temperature recommendations

VaccinesVaccine storage

temperature Diluent storage temperature Comments

Nonlyophilized, aluminum-adjuvanted vaccines

Diphtheria-tetanus–containingvaccines (DT, Td) or pertussis-containing vaccines (DTaP, Tdap)

35°F–46°F (2°C–8°C)Do not reeze.

No diluent* Irreversible loss o potency occurs withexposure to reezing temperatures.

HepA and HepB 35°F–46°F (2°C–8°C)Do not reeze.

No diluent Irreversible loss o potency occurs withexposure to reezing temperatures.

PCV 35°F–46°F (2°C–8°C)Do not reeze.


HPV† 35°F–46°F (2°C–8°C)Do not reeze.


Nonlyophilized, non–aluminum-adjuvanted vaccines

PRP-OMP Hib 35°F–46°F (2°C–8°C) No diluent —

IPV 35°F–46°F (2°C–8°C) No diluent Data on thermostability properties othese vaccines are lacking.

MCV4†,§ 35°F–46°F (2°C–8°C) No diluent Data on thermostability properties o these vaccines are lacking.

PPSV 35°F–46°F (2°C–8°C) No diluent Data on thermostability properties o

these vaccines are lacking.

TIV† 35°F–46°F (2°C–8°C) No diluent Data on thermostability properties o these vaccines are lacking.

Lyophilized (nonvaricella) vaccines

PRP-T Hib† 35°F–46°F (2°C–8°C)¶ 35°F–46°F (2°C–8°C)Do not reeze.

—

MMR† 35°F–46°F (2°C–8°C)¶ 35°F–77°F (2°C–25°C)Can be rerigerated or stored at room temperature

Do not expose to light or temperaturesabove the recommended range.

MPSV4 35°F–46°F (2°C–8°C)¶ Data are lacking on ideal pre-reconstitution storagerequirements. Ater reconstitution, vaccine should bestored at 35°F–46°F (2°C–8°C).

Do not reeze.

Freeze dried (lyophilized) vaccine. Dataon the eect o reezing temperatureon potency are lacking.

Varicella-containing vaccines

MMRV† -58°F–5°F (-50°C to -15°C) 35°F–77°F (2°C–25°C)

Can be rerigerated or stored at room temperature

—

Varicella† ≤5°F (≤–15°C) 35°F–77°F (2°C–25°C)Can be rerigerated or stored at room temperature

—

Herpes zoster† ≤5°F (≤–15°C) 35°F–77°F (2°C–25°C)Can be rerigerated or stored at room temperature

—

Noninjectable vaccines

RV5 vaccine† 35°F–46°F (2°C–8°C)Do not reeze.

No diluent —

RV1 vaccine† 35°F–46°F (2°C–8°C)Do not reeze.

The diluent may be stored at a controlled roomtemperature 20°C–25°C (68°F–77°F).

Do not reeze.

—

LAIV 35°F–46°F (2°C–8°C) No diluent Do not expose to temperatures abovethe recommended range.

Abbreviations: DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; HepA = hepatitis A; HepB = hepatitis B; Hib =Haemophilus influenzae type b; HPV = human papillomavirus; IPV = inactivated poliovirus; LAIV = live, attenuated inluenza vaccine; MCV4 = quadrivalent meningococcal conjugate vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, and varicella; MPSV4 = quadrivalent meningococcal polysaccharidvaccine; PCV = pneumococcal conjugate vaccine; PPSV = pneumococcal polysaccharide vaccine; PRP-OMB = polyribosylribitol phosphate-meningococcal outemembrane protein conjugate; PRP-T = polyribosylribitol phosphate polysaccharide conjugated to a tetanus toxoid; RV = rotavirus; RV1 = live, attenuated monovalenrotavirus vaccine; RV5 = live, reassortment pentavalent rotavirus vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, andacellular pertussis; TIV = trivalent inactivated inluenza vaccine.Source: Adapted rom Atkinson WL, Kroger AT, Pickering LK. General immunization practices. In: Plotkin SA, Orenstein WA, editors. Vaccines. 35th ed. PhiladelphiaPA: Elsevier; 2008; and CDC. Guidelines or maintaining and managing the vaccine cold chain. MMWR 2003;52:1023–5.* DTaP–Tripedia is sometimes used as a diluent or ActHib.† Protect rom light.§ There are two meningococcal conjugate vaccines; Menactra is nonlyophilized, and Menveo is lyophilized. Both powder and diluent should be stored at 35°F–46°F.¶ The lyophilized pellet may be stored at reezer temperature; the reconstituted vaccine should be stored at rerigerator temperature.

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TABLE 12. Comparison of thermometers used to monitor vaccine temperatures

Thermometer type Advantages Disadvantages

Continuous chart recorder Most accurateContinuous 24-hour readings o temperature range and

durationCan be recalibrated at regular intervals

Most expensiveRequires most training and maintenance

Minimum-maximum InexpensiveMonitors temperature range

Accurate within a range o +/–1°C.No inormation about the duration o out-o-range temperatureCannot be recalibrated at routine intervals

Standard uid flled Inexpensive and simple to useBecause thermometers encased in biosae liquids, can

relect vaccine temperatures more accurately than thosedirectly exposed to the air

Accurate within a range o +/–1°CNo inormation about duration o out-o-temperature exposureNo inormation on minimum/maximum temperaturesCannot be recalibrated at routine intervalsMight experience poor perormance rom inexpensive models

Source: Adapted rom CDC. Guidelines or maintaining and managing the vaccine cold chain. MMWR 2003;52:1023–5; and Langley A, Grant S, eds. Proceedings othe National Vaccine Storage Workshop; June 28–30; Brisbane, Australia. Maroochydore: Queensland Health; 2004.

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TABLE 13. Vaccination of persons with primary and secondary immunodeficiencies

Primary Specific immunodeficiency Contraindicated vaccines*Risk-specific

recommended vaccines* Effectiveness and comments

B-lymphocyte(humoral)

Severe antibody deiciencies (e.g., X-linkedagammaglobulinemia and commonvariable immunodeiciency)

OPV†

SmallpoxLAIVBCG Ty21a (live typhoid)

Yellow ever

PneumococcalConsider measles and

varicella vaccination

The eectiveness o any vaccine is uncertain i it depends only on the humoral response(e.g., PPSV or MPSV4).

IGIV intereres with the immune response tomeasles vaccine and possibly varicella

vaccine.

Less severe antibody deiciencies (e.g.,selective IgA deiciency and IgG subclassdeiciency

OPV†

BCGYellow everOther live vaccines appear to be sae.

Pneumococcal All vaccines likely eec tive; immune responsemight be attenuated.

T-lymphocyte(cell-mediated andhumoral)

Complete deects (e.g., severe combinedimmunodeiciency [SCID] disease,complete DiGeorge syndrome)

All live vaccines§,¶,** Pneumococcal Vaccines might be ineective.

Partial deects (e.g., most patients withDiGeorge syndrome, Wiskott-Aldrichsyndrome, ataxia- telangiectasia)

All live vaccines§,¶,** PneumococcalMeningococcalHib (i not administered

in inancy)

Eectiveness o any vaccine depends ondegree o immune suppression.

Complement Persistent complement, properdin, or actorB deiciency

None PneumococcalMeningococcal

All routine vaccines likely eective.

Phagocytic unction Chronic granulomatous disease, leukocyte

adhesion deect, and myeloperoxidasedeiciency.

Live bacterial vaccines§ Pneumococcal†† All inactivated vaccines sae and likely

eective.Live viral vaccines likely sae and eective.

Secondary HIV/AIDS OPV†

SmallpoxBCGLAIVWithhold MMR and varicella in

severely immunocompromisedpersons.

Yellow ever vaccine might have acontraindication or a precautiondepending on clinical parameterso immune unction***

PneumococcalConsider Hib (i not

administered in inancy)and meningococcalvaccination.

MMR, varicella, rotavirus, and all inactivatedvaccines, including inactivated inluenza,might be eective.§§

Malignant neoplasm, transplantation,immunosuppressive or radiation therapy

Live viral and bacterial, dependingon immune status§,¶

Pneumococcal Eectiveness o any vaccine depends ondegree o immune suppression.

Asplenia None PneumococcalMeningococcal

Hib (i not administered ininancy)


Chronic renal disease LAIV PneumococcalHepatitis B¶¶


Abbreviations: AIDS = acquired immunodeiciency syndrome; BCG = bacille Calmette-Guérin; Hib = Haemophilus influenzae type b; HIV = human immunodeiciency virus; IG = immunoglobulin; IGIV = immune globulin intravenous; LAIV = live, attenuated inluenza vaccine; MMR = measles, mumps, and rubella; MPSV4 = quadrivalent meningococcal polysaccharide vaccineOPV = oral poliovirus vaccine (live); PPSV = pneumococcal polysaccharide vaccine; TIV = trivalent inactivated inluenza vaccine.Source: Adapted rom American Academy o Pediatrics. Passive immunization. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS eds. Red book: 2009 report o the Committee on InectiouDiseases. 28th ed. Elk Grove Village, IL: American Academy o Pediatrics; 2009:74–5.

* Other vaccines that are universally or routinely recommended should be given i not contraindicated. † OPV is no longer available in the United States. § Live bacterial vaccines: BCG and oral Ty21a Salmonella Typhi vaccine. ¶ Live viral vaccines: MMR, MMRV, OPV, LAIV, yellow ever, zoster, rotavirus, varicella, and vaccinia (smallpox). Smallpox vaccine is not recommended or children or

the general public.** Regarding T-lymphocyte immunodeiciency as a contraindication or rotavirus vaccine, data exist only or severe combined immunodeiciency.

†† Pneumococcal vaccine is not indicated or children with chronic granulomatous disease beyond age-based universal recommendations or PCV. Children withchronic granulomatous disease are not at increased risk or pneumococcal disease.

§§ HIV-inected children should receive IG ater exposure to measles and may receive varicella and measles vaccine i CD4+ T-lymphocyte count is ≥15%. ¶¶ Indicated based on the r isk rom dialysis-based bloodborne transmission. *** Symptomatic HIV inection or CD4+ T-lymphocyte count o <200/mm3 or <15% o total lymphocytes or children aged <6 years is a contraindication to yellow

ever vaccine administration. Asymptomatic HIV inection with CD4+ T-lymphocyte count o 200–499/mm3 or persons aged ≥6 years or 15%–24% o total lymphocytes or children aged <6 years is a precaution or yellow ever vaccine administration. Details o yellow ever vaccine recommendations are available romCDC. (CDC. Yellow ever vaccine: recommendations o the Advisory Committee on Immunization Practices [ACIP]. MMWR 2010;59[No. RR-7].)

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TABLE 14. Approaches to evaluation and vaccination of persons vaccinated outside the United States who have no (or questionable) vaccination records

Vaccine Recommended approach Alternative approach*

MMR Revaccination with MMR Serologic testing or IgG antibodies to measles, mumps,and rubella

Hib Age-appropriate revaccination —

Hepatitis A Age-appropriate revaccination Serologic testing or IgG antibodies to hepatitis A

Hepatitis B Age-appropriate revaccination and serologic testing or HBsAg† —

Poliovirus Revaccination with inactivated poliovirus vaccine Serologic testing or neutralizing antibody to poliovirus types 1,2, and 3 (limited availability)

DTaP Revaccination with DTaP, with serologic testing or speciic IgGantibody to tetanus and diphtheria toxins in the event o asevere local reaction

Persons whose records indicate receipt o ≥3 doses: serologictesting or speciic IgG antibody to diphtheria and tetanustoxins beore administering additional doses (see text), oradminister a single booster dose o DTaP, ollowed by serologi-cal testing ater 1 month or speciic IgG antibody to diphtheriaand tetanus toxins with revaccination as appropriate (see text)

Tdap Age-appropriate vaccination o persons who are candidates or Tdap vaccine on the basis o time since last diphtheria andtetanus-toxoid–containing vaccines.

—

Varicella Age-appropriate vaccination o persons who lack evidence o varicella immunity

—

Pneumococcal conjugate Age-appropriate vaccination —

Rotavirus Age-appropriate vaccination —

HPV Age-appropriate vaccination —

Zoster Age-appropriate vaccination —

Abbreviations:DTaP = diphtheria and tetanus toxoids and acellular pertussis; HBsAg = hepatitis B surace antigen; Hib = Haemophilus influenzae type b; HPV = humanpapillomavirus; IgG = immune globulin G; MMR = measles, mumps, and rubella; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.* There is a recommended approach or all vaccines and an alternative approach or some vaccines.† In rare instances, hepatitis B vaccine can give a alse-positive HBsAg result up to 18 days ater vaccination; thereore, blood should be drawn to test or HBsAg beore

vaccinating (Source: CDC. A comprehensive immunization strategy to eliminate transmission o hepatitis B virus inection in the United States: recommendationo the Advisory Committee on Immunization Practices [ACIP]; Part I: Immunization in Inants, Children, and Adolescents. MMWR 2005;54(No. RR-16.])

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TABLE 15. Recommendations regarding interventions to improve coverage of vaccines recommended for routine use among children, adolescents, and adults

Intervention Recommendation

Increase community demand for vaccination

Client reminder or recall systems Strongly recommended

Multicomponent interventions, including education Strongly recommendedRequirements or entry to schools, child-care acilities, and colleges Recommended

Community education alone Insuicient evidenceClinic-based education Insuicient evidencePatient or amily incentives or sanctions Insuicient evidence

Client-held medical records Insuicient evidence

Enhance access to vaccination services

Reducing out-o-pocket costs Strongly recommendedEnhancing access through the U.S. Department o Agriculture’s Women, Inants, and Children program Recommended

Home visits, outreach, and case management Recommended

Enhancing access at schools Recommended

Expanding access in health care settings Recommended as part o multicomponent interventions onlyEnhancing access at child care centers Insuicient evidence

Focus on providers

Reminder or recall systems Strongly recommended

Assessment and eedback Strongly recommendedStanding orders Strongly recommended

Provider education alone Insuicient evidence

Source: Adapted rom Task Force on Community Preventive Services. Recommendations regarding interventions to improve vaccination coverage in children, adolescents and adults. Am J Prev Med 2000;18:92–6, and Task Force on Community Preventive Services. Recommendations to improve targeted vaccination coverageamong high-risk adults. Am J Prev Med 2005;28:231–7.

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FIGURE 3. Intramuscular site of administration: deltoid

Source: Adapted rom Minnesota Department o Health.

FIGURE 2. Intramuscular/subcutaneous site of administration: ante-rolateral thigh


FIGURE 1. Intramuscular needle insertion

Source: Adapted rom Caliornia Immunization Branch.

Dermis

Fatty tissue(subcutaneous)

Muscle tissue

90° angle

FIGURE 4. Subcutaneous site of administration: triceps


FIGURE 5. Subcutaneous needle insertion

Source: Adapted rom Caliornia Immunization Branch.

Dermis

Fatty tissue(subcutaneous)

Muscle tissue

45° angle

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FIGURE 6. Sample temperature log

Source: Adapted rom Immunization Action Coalition. Available at http://www.immunize.org/catg.d/p3039.pd . Accessed December 1, 2010.

Day of Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Sta Initials

Room Temp.

Exact TimeoF Temp am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm

49o

48o

47o

46o

45o

44o

43o

42o

41o

40o

39o

38o

37o

36o

35o

34o

33o

32o

8 o

7 o

6 o

5 o

4 o

3 o

Temperature Log for Vaccines (Fahrenheit)

T o o w a r m *

T o o w a r m *

T o o c o

l d *

Month/Year:______________ Days 1–15

R e f r i g e r a t o r t e m p e r a t u r e

F r e e z e r t e m p

Take immediate action if temperature is in shaded section*



Aim for 40

http://www.immunize.org/catg.d/p3039.pdf

http://www.immunize.org/catg.d/p3039.pdf

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22. CDC. Haemophilus b conjugate vaccines or prevention o Haemophilus

influenzae type b disease among inants and children two months o age and older: recommendations o the ACIP. MMWR 1991;40(No. RR-1).

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222. Poland GA, Sheer AM, McCauley M, et al. Standards or adult immunization practices. Am J Prev Med 2003;25:144–50.

223. Maciosek MV, Coield AB, Edwards NM, et al. Priorities amongeective clinical preventive services: results o a systematic review andanalysis. Am J Prev Med. 2006;31:52–61.

224. Riddiough MA, Sisk JE, Bell JC. Inluenza Vaccination. JAMA1983;249:3189–95.

225. Nichol KL. Cost-beneit analysis o a strategy to vaccinate healthy workingadults against inluenza. Arch Intern Med 2001;161: 749–59.

226. Nichol KL, Mallon KP, Mendelman PM. Cost beneit o inluenzavaccination in healthy, working adults: an economic analysis based onthe results o a clinical trial o trivalent live attenuated inluenza viruvaccine. Vaccine 2003;21:2207–17.

227. Bridges CB, Thompson WW, Meltzer MI, et al. Eectiveness andcost-beneit o inluenza vaccination o healthy working adults: arandomized controlled trial. JAMA 2000;284:1655–63.

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http://www.cms.hhs.gov/thechartseries

http://www.cms.hhs.gov/thechartseries

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AAFP American Academy o Family Physicians AAP American Academy o Pediatrics ACIP Advisory Committee on Immunization PracticesDT pediatric diphtheria-tetanus toxoid

DTaP pediatric diphtheria and tetanus toxoids and acellular pertussisFDA Food and Drug AdministrationGBS Guillain-Barré syndromeHBIG hepatitis B immune globulinHBsAg hepatitis B surace antigenHib Haemophilus influenzae type bHIV human immunodeiciency virusHPV human papillomavirusHCT hematopoietic cell transplantIgG immunoglobulin GIGIV intravenous immune globulinIPV inactivated poliovirus

LAIV live, attenuated inluenza vaccineMCV4 quadrivalent meningococcal conjugate vaccineMMR measles, mumps, and rubellaMMRV measles, mumps, rubella, and varicellaMPSV4 quadrivalent meningococcal polysaccharide vaccineOPV oral poliovirusOSHA Occupational Saety and Health AdministrationPCV pneumococcal conjugate vaccinePRP-OMP Haemophilus influenzae type b-polyribosylribitol phosphate-meningococcal outer membrane protein conjugatePPSV pneumococcal polysaccharide vaccineRV1 live, attenuated monovalent rotavirus vaccineRV5 live, reassortant pentavalent rotavirus vaccineTd adult tetanus and diphtheria toxoidsTdap tetanus and reduced diphtheria toxoids and acellular pertussis (or adolescents and adults)TIV trivalent inactivated inluenza vaccineTST tuberculin skin testVAERS Vaccine Adverse Event Reporting SystemVIS vaccine inormation statementZOS herpes zoster vaccine

Abbreviations

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Glossary Adverse event. An untoward event that occurs ater a vaccination

that might be caused by the vaccine product or vaccination process. Adverse events include those that have the ollowing characteristics:1) vaccine induced (caused by the intrinsic characteristic o the

vaccine preparation and the individual response o the vaccinee):these events would not have occurred without vaccination (e.g.,vaccine-associated paralytic poliomyelitis); 2) vaccine potentiated:the events would have occurred anyway but were precipitated by the vaccination (e.g., irst ebrile seizure in a predisposed child);3) programmatic error: the event was caused by technical errorsin vaccine preparation, handling, or administration; and 4) coin-cidental: the event was associated temporally with vaccination by chance or caused by underlying illness. Special studies are neededto determine whether an adverse event is a reaction to the vaccineor the result o another cause (Sources: Chen RT. Special meth-odological issues in pharmacoepidemiology studies o vaccine

saety. In: Strom BL, ed. Pharmacoepidemiology. 3rd ed. Sussex,England: John Wiley & Sons; 2000:707–32; and Fenichel GM,Lane DA, Livengood JR, Horwitz SJ, Menkes JH, Schwartz JF. Adverse events ollowing immunization: assessing probability o causation. Pediatr Neurol 1989;5:287–90).

Adverse reaction. An undesirable medical condition that hasbeen demonstrated to be caused by a vaccine. Evidence or thecausal relation is usually obtained through randomized clinicaltrials, controlled epidemiologic studies, isolation o the vaccinestrain rom the pathogenic site, or recurrence o the condition with repeated vaccination (i.e., rechallenge); synonyms includeside eect and adverse eect.

Adjuvant. A vaccine component distinct rom the antigen that

enhances the immune reponse to the antigen. Antitoxin. A solution o antibodies against a toxin. Antitoxin

can be derived rom either human (e.g., tetanus immune globulin)or animal (usually equine) sources (e.g., diphtheria and botulismantitoxin). Antitoxins are used to coner passive immunity andor treatment.

Hyperimmune globulin (specific). Special preparationsobtained rom blood plasma rom donor pools preselected or ahigh antibody content against a speciic antigen (e.g., hepatitis Bimmune globulin, varicella-zoster immune globulin, rabies immuneglobulin, tetanus immune globulin, vaccinia immune globulin,cytomegalovirus immune globulin, botulism immune globulin).

Immune globulin. A sterile solution containing antibodies, which are usually obtained rom human blood. It is obtainedby cold ethanol ractionation o large pools o blood plasma andcontains 15%–18% protein. Intended or intramuscular adminis-tration, immune globulin is primarily indicated or routine main-tenance o immunity among certain immunodeicient persons andor passive protection against measles and hepatitis A.

Immunobiologic. Antigenic substances (e.g., vaccines andtoxoids) or antibody-containing preparations (e.g., globulins andantitoxins) rom human or animal donors. These products are usedor active or passive immunization or therapy. Examples o immu

nobiologics include antitoxin, immune globulin and hyperimmuneglobulin, monoclonal antibodies, toxoids, and vaccines.

Intravenous immune globulin. A product derived rom bloodplasma rom a donor pool similar to the immune globulin pool,but prepared so that it is suitable or intravenous use. Intravenouimmune globulin is used primarily or replacement therapy inprimary antibody-deiciency disorders, or treatment o Kawasakdisease, immune thrombocytopenic purpura, hypogammaglobulinemia in chronic lymphocytic leukemia, and certain cases ohuman immunodeiciency virus inection (Table 5).

Monoclonal antibody. An antibody product prepared rom asingle lymphocyte clone, which contains only antibody against asingle antigen.

Simultaneous. In the context o vaccine timing and spacingoccurring on the same clinic day, at dierent anatomic sites, andnot combined in the same syringe.

Toxoid. A modiied bacterial toxin that has been made nontoxicbut retains the ability to stimulate the ormation o antibodies tothe toxin.

Vaccination and immunization. The terms vaccine and vaccination are derived rom vacca, the Latin term or cow. Vaccine was theterm used by Edward Jenner to describe material used (i.e., cowpoxvirus) to produce immunity to smallpox. The term vaccination waused by Louis Pasteur in the 19th century to include the physicaact o administering any vaccine or toxoid. Immunization is a

more inclusive term, denoting the process o inducing or providingimmunity by administering an immunobiologic. Immunizationcan be active or passive. Active immunization is the productiono antibody or other immune responses through administrationo a vaccine or toxoid. Passive immunization means the provi-sion o temporary immunity by the administration o preormedantibodies. Although persons oten use the terms vaccination andimmunization interchangeably in reerence to active immunizationthe terms are not synonymous because the administration o animmunobiologic cannot be equated automatically with develop-ment o adequate immunity.

Vaccine. A suspension o live (usually attenuated) or inactivated

microorganisms (e.g., bacteria or viruses) or ractions thereoadministered to induce immunity and prevent inectious disease orits sequelae. Some vaccines contain highly deined antigens (e.g.the polysaccharide o Haemophilus influenzae type b or the suraceantigen o hepatitis B); others have antigens that are complex orincompletely deined (e.g., Bordetella pertussis antigens or liveattenuated viruses).

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Advisory Committee on Immunization PracticesMembership List, October 2009

Chair: Carol Baker, MD, Baylor College o Medicine, Houston, Texas.

Executive Secretary: Larry Pickering, MD, National Center or Immunization and Respiratory Diseases, CDC, Atlanta, Georgia.

Members: Lance Chilton, MD, University o New Mexico, Albuquerque, New Mexico; Paul Cieslak, MD, Oregon Public Health Division, Portland, OregonKristen Ehresmann, MPH, Minnesota Department o Health, St. Paul, Minnesota; Janet Englund, MD, University o Washington and Children’s Hospitaand Regional Medical Center, Seattle, Washington; Franklyn Judson, MD, University o Colorado HealthSciences Center, Denver, Colorado; Wendy KeitelMD, Baylor College o Medicine, Houston, Texas; Susan Lett, MD, Massachusetts Department o Public Health, Boston, Massachusetts; Michael MarcyMD, UCLA Center or Vaccine Research, Torrance, Caliornia; Cody Meissner, MD, Tuts Medical Center, Boston, Massachusetts; Kathleen Neuzil, MDUniversity o Washington; Seattle, Washington; Mark Sawyer, MD, University o Caliornia - San Diego, Caliornia; Ciro Valent Sumaya, MD, Texas A&MHealth Science Center, College Station, Texas; Jonathan Temte, MD, University o Wisconsin School o Medicine and Public Health, Madison, Wisconsin

Ex Officio Members: James E. Cheek, MD, Indian Health Service, Albuquerque, New Mexico; Wayne Hachey, DO, Department o Deense, Falls ChurchVirginia; Georey S. Evans, MD, Health Resources and Services Administration, Rockville, Maryland; Bruce Gellin, MD, National Vaccine Program Oice

Washington, District o Columbia; Linda Murphy, Centers or Medicare and Medicaid Services, Baltimore, Maryland; George T. Curlin, MD, NationaInstitutes o Health, Bethesda, Maryland; Norman Baylor, PhD, Food and Drug Administration, Bethesda, Maryland; Linda Kinsinger, MD, Departmento Veterans Aairs, Durham, North Carolina.

Liaison Representatives: American Academy o Family Physicians, Doug Campos-Outcalt, MD, Phoenix, Arizona; American Academy o Pediatrics Joseph Bocchini, MD, Shreveport, Louisiana, David Kimberlin, MD, Birmingham, Alabama; American College Health Association, James C. Turner, MDCharlottesville, Virginia; American College o Obstetricians and Gynecologists, Stanley Gall, MD, Louisville, Kentucky; American College o PhysiciansGregory Poland, MD, Rochester, Minnesota; American Geriatrics Society, Kenneth Schmader, MD, Durham, North Carolina; America’s Health Insurance PlansMark Netoskie, MD, MBA, Houston, Texas; American Medical Association, Litjen Tan, PhD, Chicago, Illinois; American Osteopathic Association, StanleyGrogg, DO, Tulsa, Oklahoma; American Pharmacists Association, Stephan L. Foster, PharmD, Memphis, Tennessee; Association or Prevention Teaching andResearch, W. Paul McKinney, MD, Louisville, Kentucky; Biotechnology Industry Organization, Clement Lewin, PhD, Cambridge, Massachusetts; CanadianNational Advisory Committee on Immunization, Joanne Langley, MD, Haliax, Nova Scotia, Canada; Department o Health, United Kingdom David MSalisbury, MD, London, United Kingdom; Healthcare Inection Control Practices Advisory Committee, Alexis Elward, MD, St. Louis, Missouri; InectiousDiseases Society o America, Samuel L. Katz, MD, Durham, North Carolina; National Association o County and City Health Oicials, Je Duchin, MDSeattle, Washington; National Association o Pediatric Nurse Practitioners, Patricia Stinchield, MPH, St Paul, Minnesota; National Foundation or InectiousDiseases, William Schaner, MD, Nashville, Tennessee; National Immunization Council and Child Health Program, Mexico, Vesta Richardson, MD, MexicoCity, Mexico; National Medical Association, Patricia Whitley-Williams, MD, New Brunswick, New Jersey; National Vaccine Advisory Committee, GuthrieBirkhead, MD, Albany, New York; Pharmaceutical Research and Manuacturers o America, Damian A. Braga, Switwater, Pennsylvania, Peter Paradiso, PhDCollegeville, Pennsylvania; Society or Adolescent Medicine, Amy Middleman, MD, Houston, Texas; Society or Healthcare Epidemiology o America, HarryKeyserling, MD, Atlanta, Georgia.

Members of the General Recommendations on Immunization Working Group

Advisory Committee on Immunization Practices (ACIP), Ciro V. Sumaya, MD; Lance Chilton, MD; Susan Lett, MD; Mark H. Sawyer, MD; ACIP Liaisonand Ex-Officio Members, Doug Campos-Outcalt, MD, American Academy o Family Physicians; Georey S. Evans, MD, Health Resources and Services

Administration; Stephan L. Foster, PharmD, American Pharmacists Association; Stanley Grogg, DO, American Osteopathic Association; Harry KeyserlingMD, Society or Healthcare Epidemiology o America; CDC sta members, William L. Atkinson, MD, Angela Calugar, MD, Ted Cieslak, MD, AmandaCohn, MD, Christine Robinette Curtis, MD, Carol Friedman, DO,* Sophie Greer, Andrew Kroger, MD, Nancy Levine, PhD, Elaine Miller, Gina MootreyDO, Larry Pickering, MD, Jean Smith, MD, Greg Wallace, MD; other members and consultants, Richard Clover, MD, University o Louisville School oPublic Health; Sandra Jo Hammer, RN, Caliornia Department o Public Health; Kelly L. Moore, MD, Tennessee Department o Health; Lorry Rubin, MDSchneider Children’s Hospital; Shainoor Ismail, MD, Public Health Agency o Canada; Deborah Wexler, MD, Immunization Action Coalition; RichardZimmerman, MD, University o Pittsburgh School o Medicine.

* Deceased.

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