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Addressing immunizationbarriers, benefits, and risks

SANFORD R, KIMMEL, MD; ILENE TIMKO BURNS, MD, MPH; ROBERT M , WOLFE, MD;AND RICHARD KENT ZIMMERMAN, MD, MPH

Vaccines have been highly effective in eliminating or significantly decreasing the occurrence ofmany once-common diseases. Barriers to immunization are a significant factor in the risingincidence rates of some vaccine-preventable diseases. Cost, reduced accessibility to immuniza-tions, increasingly complex childhood and adolescent/adult immunization schedules, andincreasing focus on the potential adverse effects of vaccines all contribute to difficulty in meet-ing the 2010 immunization goals. Physicians must not only be knowledgeable about vaccinesbut they must incorporate systems in their offices to record, remind, and recall patients for vac-cinations.They must also clearly communicate vaccine benefits and risks while understandingthose factors that affect an individual's acceptance and perception of those benefits and risks.

Vaccines have almost eliminated or significantlyreduced the incidence of many diseases, but tens

of thousands of children and adults in the UnitedStates continue to develop vaccine-preventable dis-eases. Reported cases of pertussis have increased froma low of 1010 cases in 1976' to 25,827 in 2004,' withthe majority of these cases occurring in adolescentsand adults. Potential reasons for this include geneticchanges in Bordetella pertussis (which make vaccinesless effective), decreased potency of pertussis vaccines,greater awareness of pertussis, and improved diagnos-tic tests.•* However, many of these cases are believed tobe caused by waning immunity or inadequate immu-nization. In 2005, only 76.1% of US children aged 19to 35 months had received all of the recommendeddoses of DTaP, Hib, hepatitis B, MMR, polio, and vari-cella vaccines, although rates of those who receivedmost individual vaccines were higher.'' A HealthyPeople 2010 goal is to immunize 90% of young chil-dren and adolescents with age-appropriate vaccines.'

Barriers to immunization are grouped as systemsbarriers (eg, those involving the organization of thehealth care system and economics), health careprovider barriers (eg, inadequate clinician knowledgeabout vaccines and contraindications to their use), andparent or patient barriers (eg, fear of immunization-

related adverse events).' These barriers affect immu-nization rates and increase the burden of preventabledisease in our society.

Systems Barriers to ImmunizationFactors affecting the supply and distribution of vaccinesare among the most noticeable systems barriers. Thesupply of influenza, conjugate pneumococcal, and,most recently, tetravalent conjugate meningococcal(MCV4) vaccines have been inadequate due to a lack ofmanufacturing capacity.' A misdistribution of vaccineshas also occurred. Uninsured and Medicaid-insuredchildren may qualify to receive vaccines through theVaccines for Children program (VFC), but VFC doesnot provide funding to reimburse providers for thecosts of administering those vaccines. Uninsured adultsrepresent another major systems problem.

Provider Barriers to ImmunizationProviders may lack knowledge about the indicationsfor and contraindications to immunization.Expanded uses for current vaccines such as hepatitisA vaccine for children aged 12 months or older andnew vaccines against rotavirus and zoster make itdifficult for health care providers to stay currentwith immunization schedules. A study of California

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A D D R E S S I N G I M M U N I Z A T I O N B A R R I E R S , B E N E F I T S , A N D R I S K S

practices found that knowledge deficits regardingimmunization schedules, vaccine contraindications,and vaccine side effects were present among physi-cians and nonphysician office staff."

One early study indicated that almost one half ofnurses (as reported by physicians) were resistant togiving children 3 or more injections and that parentsand physicians were also uncomfortable about this.'However, a later study at an inner-city pediatric clin-ic indicated that parents overwhelmingly compliedwith physicians' recommendations for immuniza-tions.'" Thus, the attitude the physician transmits tohis or her staff about the importance of immuniza-tions is crucial. Combination vaccines that decreasethe number of shots administered at a single visitalso enhance compliance.

Logistical barriers faced by health care providersinclude the cost of immunizations, vaccine storageor capacity, and lack of access to patients' prior immu-nization records. Vaccines with stringent storagerequirements, such as varicella vaccine or live attenuat-ed influenza vaccine, may present a challenge.Fragmentation of patient care makes it more likely thatproviders will not have complete immunization recordsfor patients currently in their care. This can lead toincomplete immunization and overimmunization.

Missed visits and missed opportunities for immu-nization when necessary vaccines are not administeredat a visit are also notable barriers to timely completionof immunization requirements. When health careproviders have routinely assessed a patient's immu-nization status and notified patients and parents aboutvaccinations that were due (reminders) or overdue(recalls), immunization rates have improved.Reminder/recall systems can be time-consuming andcost-intensive, and they are used infrequently." Greateruse of electronic medical record systems should makereminder/recall systems more efficient.

Immunization registries are computerized databasesthat consolidate vaccination data from multiple healthcare providers within a defined geographic area andcan generate reminder and recall notices. Currently,48% of children younger than 6 years old participatein an immunization registry.'^ One national healthobjective calls for a participation rate of 95% of chil-dren younger than 6 years old by the year 2010.'

Patient and ParentBarriers to ImmunizationPatients or their parents or guardians may lackknowledge about immunizations, be fearful of vac-

cine safety, or lack transportation. They may beunaware of the threat of vaccine-preventable dis-eases or that safe and effective vaccines are availableagainst these diseases. Complicated immunizationschedules, fragmented care records, inconvenientclinic hours, long wait times for immunizations,transportation problems, and cost are other exam-ples of logistical barriers to immunization. Onestudy found that mothers in rural West Virginia weremore likely to have fully immunized children if theyfelt that the clinic they attended was "supportive,"which included variables such as staff who wouldclarify immunization schedules, convenient officehours, and limited wait time for immunizations.'

The VFC program has funded immunizations foruninsured and Medicaid-insured children since itsinception in 1994, but not all underinsured childrencan visit their usual source of health care and receivethese vaccines at no cost. Even low-income parentsof children who qualify for immunizations through aVFC program at their usual source of care may notbe aware of this program, and these parents contin-ue to cite cost as a barrier to immunization.'^Families who might qualify for free vaccinationsmay face other barriers such as transportation prob-lems. To limit additional patient trips to health careproviders, all eligible physicians should become VFCproviders so that immunizations can be given at thechild's medical "home." However, children who havehealth insurance that does not cover immunizationsmust continue to receive their vaccinations at publicor federally funded health clinics.

SolutionsDespite the many barriers described above, researchhas shown that some interventions can—and do—improve immunization rates (TABLE 1). In diverseadult populations, one of the strongest predictors ofinfluenza immunization is a physician's recommenda-tion to receive the vaccine.'""'̂ In low-income pediatricpopulations, enrollment in the Special SupplementalNutrition Program for Women, Infants and Children(WIC)—which offers programs to educate parentsabout the importance of immunizations—improvesimmunization rates among both urban and nonurbanpediatric populations.'^-'"

Educational resources for parents who declinevaccination because of antivaccine misinformationcan be found both in print and on the Internet.Providers should tell parents about Web sites thatpresent more balanced and useful information on the

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TflBIF 1 ,

Barriers

Knowledge deficits

• Patients and families

• Providers

Fragmented care

Vaccine shortages

Missed visits, missed opportunities

AAFP = American Academy of Family PhysSupplemental Nutrition Program for Wome

Barriers and solutions to vaccination

Solutions

• Education through WIC, community outreach, provider recommendation. Web sites

• Recognized sources of information/guidelines (AAFP, AAP, and CDC Web sites, AAP Red Book,

Shots software from vi/ww.lmmunizationEd.org)

• Immunization registries

• Improved vaccine infrastructure

• Fair reimbursement for vaccines

• Reminder/recall systems

• Fair reimbursement for vaccination

• Standing orders

• Shared responsibility for identifying needed vaccines with nursing personnel

during vital signs or through smart electronic records

• Combination vaccines to decrease number of shots required at a visit

icians; AAP = American Academy of Pediatrics; CDC = Centers for Disease Control and Prevention; WIC = Specialn, Infants and Children.

risks and benefits of vaccination as well as links toother sources. Among these Web sites are the following:

• American Association of Pediatrics (AAP):www.aap.org

• US Centers for Disease Control and Pre-vention (CDC): www.cdc.gov/nip

• Society of Teachers of Family Medicine'sGroup on Immunization Education (GIE):www.ImmunizationEd.org

• Vaccine Information Center at the Children'sHospital of Philadelphia: www.chop.edu

• Immunization Action Coalition (IAC):www.vaccineinformation.org

Parents opposed to immunizations are often dis-trustful of "official" sources but may be more willingto accept information from their personal physicianwho takes time to listen to their concerns andrespond in a thoughtful manner.

Immunization registries are being developed in allstates and in the District of Columbia.'' In 2002, 43%of all US children had at least 2 immunizations record-ed in a registry. However, about 40% of children in theregistries had incomplete or missing data on adminis-tered doses of vaccine.'' Lack of time or staff to enterdata as well as possible transcription errors may makesome physicians hesitant to use these systems; howev-er, they save time when immunization records arerequested for school or camp forms and improveimmunization rates." Another study also showed thatcomplete computerization of paper immunizationrecords saved both time and money."

The Task Force on Community PreventiveServices recommended or strongly recommendedimplementation of the following measures toincrease immunization rates'̂ ":

• Reminder/recall systems for patients, families,and providers

• Requirement of vaccination as a prerequisitefor enrollment in school and childcare

• Decreases in out-of-pocket costs for patients/families

• Assessment of—and collection of feedbackregarding—immunization rates for individualproviders

• Issuance of standing orders for adult immunization• Provision of immunization services in homes

and WIC settings• Implementation of multicomponent interven-

tions that expand access to services and provideeducation to target populations.

Interventions tailored to the culture of aprovider's practice and its patients should increaseimmunization rates. A study of tailored standingorders, reminders, and express vaccination servicesin inner-city clinics found that these measures led toan increase in influenza immunization

Communicating the Benefitsand Risks of VaccinesThe benefits of immunization are often obvious tohealth care providers; however, patients, parents, andthe general public may have questions or concerns.

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As knowledge of the devastation caused by manyvaccine-preventable diseases fades from public mem-ory, attention shifts to the occasionally seriousadverse events that may follow immunization. Thedissemination of (mis)information and anecdotalreports of alleged vaccine reactions by the media, theInternet, and antivaccine groups causes parents,patients, and even some health care providers toquestion the justification for immunizations.^^ Somephysicians may be reluctant to administer immuniza-tions because of liability concerns. An Ohio studydemonstrated that liability concerns influenced thedecisions of 9% of family physicians and 23% ofpediatricians in their choice of polio vaccines."Consequently, vaccines have become victims of theirown success. If a loss of confidence in the vaccinedevelops, then an outbreak of disease may ensue,resulting in resumption of vaccine use."

Public Perceptions of Vaccine SafetyParents of incompletely immunized British childrenwere likely to report that immunization was riskier fortheir child than was nonimmunization due to concernsabout vaccine-related side effects, the belief that theirchild was not at risk for the disease, or the belief thatthe disease was not serious." In the United States, con-cerns about vaccine safety are more common amongparents of underimmunized children, but many par-ents of fully immunized children have also expressedsuch concerns." Most family physicians and almost allpediatricians reported at least 1 vaccine refusal fromparents during the year 2000.̂ "̂ A Canadian studyfound that most mothers would accept a 1:100,000 to1:1,000,000 risk for a severe vaccine side effect; how-ever, 14% would not tolerate any serious risk."

Common MisconceptionsAbout VaccinesMost parents support immunizations for their chil-dren, but misconceptions do exist. Some parentsbelieve that the administration of too many immu-nizations will weaken their child's immune system^'or cause chronic diseases such as asthma, autism,diabetes mellitus (DM), or multiple sclerosis (MS).^'Some believe that vaccine-preventable diseases hadalready begun to disappear prior to the use of vac-cines or that there are "hot lots" of vaccines thathave a greater frequency and/or severity of adverseevents.^' Others believe that vaccines are not "natu-ral" and thus prefer disease-induced immunity.Individuals often use cognitive shortcuts or heuris-

tics to simplify complex decisions and judgments.•"'Parents who are nonvaccinators may believe theycan control their child's susceptibility to disease,have doubts about the reliability of vaccine informa-tion, prefer errors of omission over errors of com-mission, or rely on herd immunity to protect theirchild.^' TABLE 2 summarizes heuristic factors thataffect vaccine-related risk perception.™

Multiple Vaccines and the Immune SystemAlmost 25% of parents believe that "children getmore immunizations than are good for them."^*However, most parents and many providers may notrealize that the actual number of antigens in thesevaccines has decreased. For example, the olderwhole-cell pertussis vaccine had approximately 3000antigens compared with 1 to 7 for newer acellularpertussis vaccines.-"^ Rather than weakening theimmune system, vaccines may prevent infections thatpredispose individuals to serious diseases. For exam-ple, varicella is often complicated by necrotizinggroup A beta-hemolytic streptococcal fasciitis inchildren or by pneumonia in adults.^^

Explaining Vaccine Benefits and RisksPhysicians serve as the primary source of immuniza-tion information for most parents and patients. Inone national survey, 84% of respondents indicatedthat they received immunization information from adoctor.^* Physicians must accurately portray the ben-efits of immunization while acknowledging that vac-cines are not always effective and—in rare cases—may be accompanied by serious adverse events.Providers should inform patients that vaccines arebiologic agents intended to stimulate immunity andcommonly cause local reactions such as redness,swelling, and soreness at the injection site.

Physicians or other providers must provide thecurrent Vaccine Information Statement (VIS) eachtime they administer a vaccine covered under theNational Vaccine Injury Compensation Program(www.hrsa.gov/vaccinecompensation/table.htm) orpurchased through a CDC grant." They must record ineach patient's medical record the date of administra-tion, the vaccine manufacturer, the lot number, and thename and business address of the provider, along withthe edition of the VIS that was given to the patient andthe date on which the vaccine was administered.^^Copies of each VIS can be obtained from the CDC atwww.cdc.gov/nip/publications/vis or the ImmunizationAction Coalition at www.immunize.org. Because physi-

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TflRI F •) .

Factors or heuristic processes that affect vaccine acceptance

Factors or Processes That May Decrease Vaccine Acceptance

Factor

Compression

1 Omission (not taking action) bias

versus commission (action) bias

Ambiguity aversion

Voiuntary, controllable risi<s

Naturai risi<s

Frightening or memorabie risks

Avaiiabiiity

• Freeioading

Comment

Overestimate frequency of rare risks (eg, vaccine reactions) and underestimate frequency of common

risks (eg, morbidity and mortality from vaccine-preventabie diseases).

May lead to vaccine refusai by parent who thinks, "if my child gets a vaccine reaction, it's my fauit;

if my chiid gets a disease, it's an act of God or Nature." The parent feels isss iiable or guiity from an

act of omission than from an act of commission.

Known risks may be more acceptable than unknown risks of iesser magnitude, eg, risks of disease

vs new vaccine.

More acceptable than involuntary risks, eg, some oppose mandatory immunizations, citing lack of choice.

More acceptable than man-made risks, eg, risk for natural disease is more acceptable than

man-made vaccine-related risk.

Frightening risks are less acceptable than less frightening or memorable risks, eg, dying from a shark

attack is more frightening than an automobile accident.

An event that is available (accessible or easily remembered) can lead to overestimation of its frequency.

eg, sensationalized media reports alleging vaccine injury.

Vaccine refusers rely on high vaccination rate and herd immunity to protect their unvaccinated loved ones.

However, this increases the risk for everyone.

Factors or Processes That May Increase Vaccine Acceptance

Factor

; Bandwagoning

Aitruism

Comment

Vaccinate because everyone else is.

Accept personal risk to benefit community or society.

Ball LK, ct al. Pediatrics. 1998;1O1:453-458.Copyright © 2005, Society of Teachers of Family Medicine. Used with permission.

dans and nurses cite time as the most common barrierto communicating with patients about vaccine risksand benefits,̂ '' providing the appropriate VIS before avisit or while a patient and his or her parent(s) are wait-ing may facilitate subsequent discussions.

Addressing Parents' ConcernsParents who refuse immunization for their childrenmay have personal, cultural, religious, or experientialreasons for their refusal. Physicians should acknowl-edge parents' concerns and respectfully try to correctany misinformation. Allowing parents to express theirconcerns will increase their willingness to listen to thephysician's views. In some cases, parents may be will-ing to accept partial vaccination or to allow the physi-cian to gradually administer vaccinations if they areprovided slowly over several visits. If a patient orhis/her parents continue to refuse vaccination, then thephysician should document the discussion in the med-ical record. Some physicians may wish to have parents(or children if they are legally able to give consent) signa statement acknowledging that vaccinations wererefused. A sample form can be obtained fromwww.cispimmunize.org/pro/pdf/Refusalto Vaccinate_

2pageform.pdf. The CDC pamphlet Six CommonMisconceptions Ahout Vaccination and How to Respondto Them can be obtained from www.cdc.gov/nip/publications/6mishome.htm.

When parents exhibit omission bias (TABLE 2),the physician may reframe the issue from the child'spoint of view. One investigator found that "individu-als opposed to vaccination could be persuaded to vac-cinate if they placed themselves in the child's positionand then asked themselves whether they preferred agreater or lesser chance of death, and whether it mat-tered if the outcome occurred as the result of some-one's act or omission."^" Parents may subsequentlyacknowledge that, from the child's point of view, itwould not matter whether injury resulted from a nat-urally occurring disease or a vaccine injury.

Parents who refuse immunization because theybelieve that immunization of other children protectstheir child ("freeloading") should be informed thatsuch action actually increases the risk for diseasewith respect to not only their child but also others'vaccinated children. A Colorado study demonstratedthat children exempted from vaccines were at least22 times more likely to acquire measles and almost

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6 times more likely to develop pertussis than werevaccinated children.^^

Common Vaccine RisksPain, swelling, and redness at the injection site arecommon local reactions following immunization.Sterile abscesses occasionally occur after injection ofinactivated vaccines.̂ ^ Fever and irritability are com-mon systemic reactions that may be attenuated by giv-ing acetaminophen. More reports of fever, redness,swelling, and pain at the injection site have been madeafter the fourth dose than the first dose of each of thelicensed DTaP vaccines. Swelling of the entire thigh orupper arm that lasts for a mean of 4 days has occurredin 2% to 3% of children after their fourth or fifthdose of the same DTaP.'*̂ However, local reactions tovaccines or their components usually are not consid-ered contraindications for vaccine administration.

Uncommon Vaccine RisksAllergic reactions occur infrequently after immu-nizations. For example, the rate of anaphylaxis afterhepatitis B vaccine is 1 in 600,000.^^ Yeast proteinsmay cause this reaction." Gelatin, a vaccine stabiliz-er, is used in the production of the MMR and vari-cella vaccines. However, persons with a history offood allergy to gelatin rarely develop anaphylaxisafter vaccine administration.^^ The MMR vaccine—but not the influenza vaccine—may be given to per-sons with egg allergy. Neomycin is used in the pro-duction of the MMR, varicella, inactivatedpoliovirus vaccines, and some combination vaccines(eg, HAV/HBV and DTaP/IPV/HBV) and may causea delayed-type local hypersensitivity reaction 48 to96 hours after administration.^^

Febrile seizures, persistent crying that lasts 3hours or more, and hypotonic-hyporesponsiveepisodes have been reported very rarely after DTaP.̂ "

TABLES 3 AND 4 compare the risks for wildmeasles, mumps, rubella, and varicella disease with therisks for adverse events reported after administrationof the MMR and varicella vaccines.""'" The temporalrelation of adverse events to vaccine administrationdoes not prove causation. TABLES 3 AND 4 also citethe efficacy of the vaccines in preventing disease.

Controversial and Unproven RisksChronic diseases such as autism often are attributed tovaccines because immunizations are given at a time inchildren's lives when the signs and symptoms of thosediseases first become apparent. Parents are under-

standably frustrated by the lack of an identifiablecause of their child's autism and, in their search foranswers, may allege that vaccines caused their child'sillness because of the temporal relationship betweenimmunization and disease manifestation.

Well-controlled studies have not documented acausal relation between administration of theMMR vaccine and development of autism. A studyby Wakefield et al of 12 children with gastrointesti-nal diseases and developmental regression hypoth-esized that such a causal relation might exist."However, Taylor et al conducted a study thatincluded 498 autistic children in the North Thameshealth district of the United Kingdom and found nocausal association between MMR vaccine andautism." Patja et al did not identify any cases ofautism associated with almost 3 million doses ofMMR vaccine given to 1.8 million individuals inFinland over 14 years.'''' Madsen et al compared therecords of more than 400,000 Danish children whoreceived MMR vaccine with those of more than90,000 unvaccinated children.''' The investigatorsdid not find any increase in the relative risk forautistic disorder in vaccinated children over thatfor unvaccinated children.^''

Allegations also have been made that hepatitis Bvaccine causes chronic fatigue syndrome, MS, orother autoimmune disorders." The Nurses' HealthStudy in the United States evaluated more than200,000 women and did not find an associationbetween hepatitis B vaccine and MS." A Europeanstudy found that administration of the tetanus,hepatitis B, or influenza vaccines did not increasethe risk for short-term relapse in MS patients."

Vaccines have not been shown to increase therisk for type 1 DM.^'-" A Swedish study found thatvaccination against tuberculosis, smallpox, tetanus,pertussis, rubella, or mumps did not increase therisk for type 1 DM.*" A Vaccine Safety Datalinkproject of the CDC did not find an increased risk fortype 1 DM with any of the routinely recommendedchildhood vaccines, including those for DTaP, hepa-titis B, Hib, MMR, and varicella." A Danish studydid not find any significant association of type 1DM with Hib, DTaP, MMR, or oral polio vaccines.'^"

Concern also has been expressed that thimerosal,an ethyl mercury-containing vaccine preservative,might lead to greater mercury exposure in infantsreceiving multiple thimerosal-containing vaccines.However, multiple epidemiologic studies have notfound a causal association between autistic-

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I. Risks and Sequelae

Risk of acquiring diseasei Highest number

of US cases

1

1

1 Recent number

' of US cases

! Transmission routei

Rate of transmission to

j susceptible household, contacts

Risk of sequelae

j Case-fatality rate

: Encephalitis

1 Subacute sclerosing

; panencephaiitis

1 Pneumonia

Thrombocytopenia

j Orchitis

' Anaphylaxis

1 Vaccine efficacy

Measles, mumps, and rubella disease and vaccine fact sheet

Measles Disease

894,134 in 1941'

66 in 200?

Droplet spray

90%'

1-3 deaths/I 000

measles cases'''

1-2 cases/1000

measles cases'

8.5 cases/1 million

measles cases"

1%-6%=

Copyright © 2005, Society of Teachers of Faniily Medicine'Maldonado Y. In: Behrman ct alMMWR Morh Mortal Wkly RepAmerican Academy of Pediatrics;

eds. Nelson Textbook of2006:5S;883-903; 'Picke

Mumps Disease

152,209 in 1968'

314 in 2005'

Direct contact.airborne droplets.and fomites'

1.6-3.8 per

10,000 cases'

2% fatality if

patient develops

encephalitis'

2.5 cases per 1000

mumps cases'

14%-35%

adolescent

and adult men'

Used with permission.Pediatrics. Philadelphia,

Rubella Disease

12 million in 1964-1965':57,686 in 1969 (20,000cases of congenital rubellain 1964-1965)'

11in2005''"

(1 case of congenitalrubella in 2005F

Direct contact.nasopharyngeal dropletcontact, or transplacental

50%-60% of susceptiblefamily members andalmost 100% inclosed populations'

1 death per 30,000 cases

due to 20% fatality from

encephalitis'

1/5000-1/6000 rubella

cases'*

20 total cases of progressive

rubella panencephalitis

since 1974'

1/3000 rubella cases'̂

Measles, Mumps, Rubella Vaccine

No cases of congenital rubella

reported after immunization ofpregnant women, but the theoreticalmaximum risk is 2% vs at least 30%risk after wild rubella infection infirst trimester*

1 death not attributed to vaccine."

Fatal measles pneumonitis in one

21-year-old man with advanced HIV

<1 case/million doses'

0-0.7 cases/million doses'

2 cases/million doses"

0.5-40 cases/million recipients'

0.3 case/million doses"

5 cases/million doses:

none were fatal"

95% with single dose at 12 months of

age

>99% if receive 2 doses separated by

at least 4 weeks and first dose given

>12 months of age'

Pa: WB Saunders Co; 2004; ^Centers for Disease Control and Prevention.ing LD, ed. Red Book: 2003 Report of the Committee on Infectious Diseases. Elk Grove Villat-e, III:

2003; 'Feikin DR, et al. JAMA. 2000;284:3145-3150; 'Gershon A. In: Mandell et al.Diseases. Philadelphia, Pa: Churchill Livingstone; 2000; "Patja A, et al. Pediatr Infect Dis ]. 2OOO;19:1127-1134; 'BaumPrinciples and Practice of Infectious Diseases. Philadelphia,Pa: Churchill Livingstone; 2000.

^ds. Principles and Practice of InfectiousSG, Litman N. In: Mandell et al, eds.

spectrum disorders and thimerosal-containingvaccines."* '̂ The Institute of Medicine concludedthat "the evidence favors rejection of a causal rela-tionship between thimerosal-containing vaccinesand autism."" Common childhood vaccines now

contain either no thimerosal or trace amounts of it.Hepatitis B vaccines, Hib vaccine, and all brands ofDTaP vaccine have formulations that are availablefor infants that contain either no thimerosal or traceamounts of it. There is no thimerosal in the inacti-

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TABLE 4 i = r r - ' =

1 Risks and Sequelae

Risk of acquiring disease

Average number of US cases/yearRate of transmission tosusceptible contactsTransmission route

Risk of sequelae

• Localized rash

Generalized varicella-like rash

; Invasive group A streptococcal disease

Anaphylaxis

Herpes zoster (children <20 years old)

Thrombocytopenia

Arthropathy

Cerebellar ataxia

i Encephalitis

Pneumonia

i Congenital varicella syndrome

Deaths

Vaccine effectiveness

Varicella disease and vaccine fact

Varicella Disease

3.7 million (1980-1990)'90%'

Direct contact or airborne spread respiratorytract secretions; transplacental passage

100%

5.2/100,000 with varicella vs

0.09/100,000 without varicella"

68/100,000 person-year'

l%-2%^

1/4000 cases'

0.1%-0.2%'

1/400 adult cases'

0.4% between 0 and 12 weeks'

2% between 13 and 20 weeks

2-3/100,000 cases*

sheet

Varicella Vaccine

3 confirmed cases secondary to transmission

in immunocompetent persons'-'

3%-5%-'

3%-5%'

lease from 1995-1998 in VAERS=*

30 nonfatal cases in VAERS'*

2.6/100,000 doses'

0.3/100,000 doses in VAERS=*

0.5/100,000 doses in VAERS=*

0.4/100,000 doses in VAERS'*

0.3/100,000 doses in VAERS''*

0.2/100,000 doses in VAERS''*

14 from 1995-1998 in VAERS=*

Vaccine not confirmed as cause

70%-85% against mild infection'

>95% against moderate to severe disease'

•̂ VAERS is the Vaccine Adverse Event Reporting System, a passive surveillance system. Data from VAERS do not prove association of an adverse event with thevaccine, but may prompt further investigation. The VAERS reporting rate is adverse event per estimated vaccine doses sold.*̂'ACIP. MMWR Recomm Rep. l996;45(RR-11):l-36; ^Laupland KB, et al. Pediatrics. 2000;105:e(30; 'Pickering LD, ed. Red Book: 2003 Report of the Committeeon Infectious Diseases. Elk Grove Village, 111; American Academy of Pediatrics; 2003; ^Myers MG, et al. In: Behrman et al, eds. Nelson Textbook of Pediatrics.Philadelphia, Pa: WB Saunders Co; 2004; 'Whiteley RJ. In: Mandell et al, eds. Principles and Practice of Infectious Diseases. Philadelphia, Pa: Churchill Livingstone;2000; 'Wise RP, et al. JAMA. 2000;284:1271-1279.

Copyright © 2005 Society of Teachers of Eaniily Medicine. Used with permission.

vated poliovirus, MMR, varicella, pneumococcalconjugate, or MCV4 vaccines. Pediatric and adultinfluenza vaccines that contain trace amounts ofthimerosal are now available in unit doses.

Reporting Vaccine Adverse EventsManufacturers, state health coordinators, healthcare providers, and parents may submit reports ofadverse events to the Vaccine Adverse EventReporting System (VAERS) by calling 800-822-7967, visiting the VAERS Web site (http://vaers.hhs.gov), or using a form found in thePhysicians' Desk Reference. Definitions of injuriesthat may merit compensation and further informa-tion regarding eligibility and documentation ofclaims may be obtained from the National VaccineInjury Compensation Program at 800-338-2382 orat www.hrsa.gov/vaccinecompensation/.

ConclusionAH physicians who provide vaccinations should assessand develop approaches to increase immunizationrates in their own practices. They should educatethemselves and other health care providers in theirpractices about current vaccine recommendations(including contraindications) and educate patientsand families about the benefits and risks of immuniza-tions. In this age of information and disinformation,the importance of properly communicating the bene-fits and risks of vaccines cannot be overstated.Physicians should not dismiss parents' concerns out ofhand. Exploring the reasons for these concerns andsharing accurate information can go a long waytoward alleviating parental anxiety. Providing basicimmunization information is not only good medicine,but the appropriate VIS must be provided each time avaccine is administered.

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