Risky Business: Risky Business: Talking to Parents Talking to Parents

about Vaccinesabout VaccinesNC Immunization ConferenceNC Immunization Conference

August 2011August 2011

Kristina Simeonsson, MD, MSPHKristina Simeonsson, MD, MSPH

Karin Hillenbrand, MDKarin Hillenbrand, MDThe Brody School of Medicine at The Brody School of Medicine at

ECUECU

Educational Objectives

Recognize factors that contribute to Recognize factors that contribute to the controversy surrounding the controversy surrounding vaccinesvaccines

Incorporate principles of “risk Incorporate principles of “risk communication” when discussing communication” when discussing immunization with parentsimmunization with parents

Identify the most common concerns Identify the most common concerns parents have about vaccinesparents have about vaccines

Develop an approach for counseling Develop an approach for counseling the vaccine-hesitant parentthe vaccine-hesitant parent

MMR Vaccine Gets a Bad MMR Vaccine Gets a Bad ReputationReputation

Wakefield “study” published in 1998Wakefield “study” published in 1998 Case series of 8 children whose Case series of 8 children whose

symptoms of autism appeared within symptoms of autism appeared within one month of receiving MMR vaccineone month of receiving MMR vaccine

Autism spectrum disorder

Received MMR vaccine 8

Determination of whether MMR Determination of whether MMR vaccine causes autism requires four vaccine causes autism requires four

separate pieces of dataseparate pieces of dataAutism spectrum disorder

No autism spectrum disorder

Received MMR vaccine

A B

Did not receive MMR vaccine C D

Offit PA, Coffin SE; Vaccine 2003

Background: ParentsBackground: Parents

Parents’ perceptions about the dangers Parents’ perceptions about the dangers of vaccines is key in their decision to of vaccines is key in their decision to have their child vaccinatedhave their child vaccinated

Lack of disease awareness prompts Lack of disease awareness prompts greater reluctance to accept adverse greater reluctance to accept adverse reactionsreactions

Consumerism is on the riseConsumerism is on the rise Parents often trust information from Parents often trust information from

the media, regardless of the sourcethe media, regardless of the source

Getting vaccines is a good way to protect my child from disease.

90%

Generally I do what my doctor recommends about vaccines for my child.

88%

I am concerned about serious adverse effects of vaccines.

54%

New vaccines are recommended only if they are as safe as older vaccines.

51%

Parents should have the right to refuse vaccines that are required for school for any reason.

31%

Some vaccines cause autism in healthy children.

25%

My child does not need vaccines for diseases that are not common anymore.

11%

Parental Perspectives on Vaccine

Freed et al, Pediatrics 2010

Background: Providers

Providers vary in their delivery of information about vaccines may be uninformed, dismissive,

disparaging Providers may send mixed messages

invoke policies that conflict with our own science

thimerosal removed publication of flawed studies publication of popular parenting books

Wakefield Study Wakefield Study RetractedRetracted

Case series was not Case series was not consecutiveconsecutive

Data on timing of autistic Data on timing of autistic features and features and gastrointestinal symptoms gastrointestinal symptoms was alteredwas altered

Study was funded by Study was funded by lawyers lawyers

Children were put through Children were put through invasive procedures invasive procedures without appropriate without appropriate consentconsent

Background: MediaBackground: Media Increased access to information and Increased access to information and

misinformationmisinformation Volume of non-science-based material exceeds that Volume of non-science-based material exceeds that

from reliable sourcesfrom reliable sources 24/7 news is a business industry24/7 news is a business industry

Controversy and bad news attract a larger Controversy and bad news attract a larger audienceaudience

““Balanced coverage” can mean giving equal time Balanced coverage” can mean giving equal time to outlier viewsto outlier views

Social networkingSocial networking Celebrity scienceCelebrity science

Pertussis Outbreak in Pertussis Outbreak in Chapel HillChapel HillFebruary 2009February 2009

Cases Of Cases Of Whooping Cough Whooping Cough Plague Chapel Hill-Plague Chapel Hill-Carrboro Schools Carrboro Schools

Whooping Cough Whooping Cough Outbreaks Show Outbreaks Show Vaccine’s Limits Vaccine’s Limits

MMR Controversy in the United MMR Controversy in the United KingdomKingdom

More than 50%More than 50% of of parents interviewed parents interviewed believed that equal believed that equal evidence existed for evidence existed for both sides of the both sides of the debatedebate

Less than 25% Less than 25% were were aware that bulk of aware that bulk of evidence favors evidence favors supporters of the supporters of the vaccinevaccine

Autism spectrum disorder

Received MMR vaccine

8

Hargraves et al, Hargraves et al, Economics and Economics and Research CouncilResearch Council, 2003, 2003

Refusal versus HesitancyRefusal versus Hesitancy

Many parents express concerns about the Many parents express concerns about the safety of vaccines and should not safety of vaccines and should not automatically be categorized as being automatically be categorized as being staunchly anti-vaccinationstaunchly anti-vaccination

Parental Report of Level of Parental Report of Level of Trust of Certain People for Trust of Certain People for Vaccine Safety InformationVaccine Safety Information

A lot Some Not at all

My children’s doctor 76 22 2

Other health care providers 26 70 4

Government experts/officials 23 61 16

Family and friends 15 67 18

Parents who believed their child was harmed by a vaccine

8 65 27

Celebrities 2 24 74

Freed GL et al, Pediatrics 2011

Responding to Parent Responding to Parent ConcernsConcerns

Explore and address parental concernsExplore and address parental concerns May need to discuss vaccines separatelyMay need to discuss vaccines separately

Provide parents with risk and benefit Provide parents with risk and benefit information necessary to make an information necessary to make an informed decisioninformed decision

Correct an misinformation or Correct an misinformation or misperceptions that existmisperceptions that exist 25% of parents falsely believe that the 25% of parents falsely believe that the

immune system could become weakened immune system could become weakened by too many vaccinesby too many vaccines

Diekema D and the Committee on Bioethics, Pediatrics 2005

Communication Communication StrategiesStrategies

Improve communication skills of public Improve communication skills of public and private health leadersand private health leaders

Present information in perspectivePresent information in perspective Avoid obfuscationAvoid obfuscation Admit gaps in knowledgeAdmit gaps in knowledge Be available and candid in answering Be available and candid in answering

questionsquestions Invest in research on what is truly Invest in research on what is truly

driving parents’ questions and concernsdriving parents’ questions and concerns

Cooper LZ, Larson HJ, Katz SL. Pediatrics, 2008

Risk CommunicationRisk Communication

Developed from the need to find Developed from the need to find more effective ways to communicate more effective ways to communicate health riskshealth risks

Goal is to provide information about Goal is to provide information about expected type and magnitude of an expected type and magnitude of an outcome from a behavior or outcome from a behavior or exposureexposure

The purpose of the message is to The purpose of the message is to empower decision-making

Sandman’s Model of Public Perception of Risk

Hazard Scientific estimation of mortality or

morbidity

Outrage Factors that make the public worried,

angry, frightened or otherwise upset

Not All Risks Are Created Not All Risks Are Created EqualEqual

VoluntaryVoluntary FamiliarFamiliar Natural originNatural origin AdultAdult Understood benefitUnderstood benefit

InvoluntaryInvoluntary ExoticExotic ManmadeManmade ChildrenChildren Questionable Questionable

benefitbenefit

Crisis and Emergency Risk CommunicationCenters for Disease Control and Prevention, September 2002

Principles of Emergency Principles of Emergency Risk CommunicationRisk Communication

Stop trying to allay panicStop trying to allay panic Emphasize there is a process in placeEmphasize there is a process in place Don’t over reassureDon’t over reassure Acknowledge uncertaintyAcknowledge uncertainty Acknowledge people’s fearsAcknowledge people’s fears Express wishesExpress wishes Give people things to doGive people things to do Acknowledge the shared miseryAcknowledge the shared misery Give anticipatory guidanceGive anticipatory guidance Address dreaded “what if” questionsAddress dreaded “what if” questions Be a role model and ask more of peopleBe a role model and ask more of people Be regretfulBe regretful

Crisis and Emergency Risk CommunicationCenters for Disease Control and Prevention, September 2002

Principles of Emergency Principles of Emergency Risk CommunicationRisk Communication

Stop trying to allay panicStop trying to allay panic Emphasize there is a process in placeEmphasize there is a process in place Don’t over reassureDon’t over reassure Acknowledge uncertaintyAcknowledge uncertainty Acknowledge people’s fearsAcknowledge people’s fears Express wishesExpress wishes Give people things to doGive people things to do Acknowledge the shared miseryAcknowledge the shared misery Give anticipatory guidanceGive anticipatory guidance Address dreaded “what if” questionsAddress dreaded “what if” questions Be a role model and ask more of peopleBe a role model and ask more of people Be regretfulBe regretful

Emphasize a Process is Emphasize a Process is in Placein Place

There is a process to monitor There is a process to monitor vaccine safety.vaccine safety. pre- and post-licensure vaccine safety pre- and post-licensure vaccine safety

surveillancesurveillance Vaccine trialsVaccine trials Vaccine Safety DatalinkVaccine Safety Datalink Vaccine Adverse Event Reporting System Vaccine Adverse Event Reporting System

Don’t Over ReassureDon’t Over Reassure

Speak openly and honestly about the Speak openly and honestly about the side effects and risks of vaccinesside effects and risks of vaccines

Acknowledge UncertaintyAcknowledge Uncertainty

Offer what you know versus what Offer what you know versus what you don’t knowyou don’t know We don’t know the cause(s) of autism We don’t know the cause(s) of autism We do know multiple independent We do know multiple independent

studies have shown no link between studies have shown no link between autism and MMRautism and MMR

We do know multiple independent We do know multiple independent studies have shown no link between studies have shown no link between thimerosal and autismthimerosal and autism

Acknowledge People’s Acknowledge People’s FearsFears

Even when fear is unjustified…Even when fear is unjustified… it doesn’t respond well to being ignoredit doesn’t respond well to being ignored It doesn’t respond well to criticismIt doesn’t respond well to criticism It doesn’t respond well to statisticsIt doesn’t respond well to statistics

Give People Things to DoGive People Things to Do

Encourage parents to review Encourage parents to review educational material that you trust educational material that you trust and agree to discuss at next visitand agree to discuss at next visit

Provide references that are parent Provide references that are parent and provider friendlyand provider friendly

Refer parents to websites that are Refer parents to websites that are parent and provider friendlyparent and provider friendly

Give Anticipatory Give Anticipatory GuidanceGuidance

If you are aware of future negative If you are aware of future negative outcomes, let people know what to outcomes, let people know what to expectexpect Risks of diseaseRisks of disease Spread of disease to other vulnerable Spread of disease to other vulnerable

individualsindividuals Possibility of isolation / quarantine Possibility of isolation / quarantine

during outbreaksduring outbreaks

Be a Role Model and Ask Be a Role Model and Ask More of PeopleMore of People

May want to mention that you are up May want to mention that you are up to date on your vaccines…to date on your vaccines…

May want to mention that your May want to mention that your children, grandchildren, nieces, children, grandchildren, nieces, nephews, etc. are vaccinatednephews, etc. are vaccinated

Ask people to help you provide a Ask people to help you provide a community where children are safer community where children are safer from diseasesfrom diseases

No Benefit…?No Benefit…?

Vaccines are a victim of their own Vaccines are a victim of their own success!success!

Never seen, rarely hear aboutNever seen, rarely hear about If we give a bunch of children vaccines, If we give a bunch of children vaccines,

and no one catches anything, where’s and no one catches anything, where’s the news in that?the news in that?

Risk Risk fromfrom disease is low disease is low Risk Risk ofof disease is low disease is low

Counseling Counseling ParentsParents

Vaccine Vaccine Information Information Statements Statements (VIS)(VIS)

available from CDC, Immunization Action Coalition

Do we still need Do we still need vaccines?vaccines?

common diseases: serious sequelaecommon diseases: serious sequelae pertussis, pneumococcus, chickenpox, pertussis, pneumococcus, chickenpox,

hepatitishepatitis rare but persistent disease: drop in rare but persistent disease: drop in

vaccine coverage will cause resurgencevaccine coverage will cause resurgence measles, mumps, rubella, H.flu type b, measles, mumps, rubella, H.flu type b,

tetanustetanus disease eliminated from US: “only a disease eliminated from US: “only a

plane ride away”plane ride away” polio, diphtheria, (smallpox)polio, diphtheria, (smallpox)

Too Many Vaccines?

in a national survey of parents: 23% questioned the number of shots

given to children 25% were convinced vaccines weaken

the immune system

Gellin BG, Maibach EW, Marcuse EK. Pediatrics. 2000.

Do multiple vaccines Do multiple vaccines overwhelm the immune overwhelm the immune

system?system? vaccine antigens are a very small vaccine antigens are a very small

subset of the environmental exposures subset of the environmental exposures for the immune systemfor the immune system

ability to respond to extremely large ability to respond to extremely large numbers of distinct microbesnumbers of distinct microbes able to generate protective immune able to generate protective immune

responses to multiple vaccines at onceresponses to multiple vaccines at once vaccinated children get fewer vaccinated children get fewer

infections (both vaccine-preventable infections (both vaccine-preventable and unrelated)and unrelated)

Are infants too young to Are infants too young to get vaccines?get vaccines?

newborns can mount an immune newborns can mount an immune response from birth response from birth

serious diseases may affect serious diseases may affect young infantsyoung infants

Alternative and Delayed Alternative and Delayed SchedulesSchedules

Schedules designed to delay vaccine Schedules designed to delay vaccine administration incur risks: administration incur risks: susceptible to disease for a longer time periodsusceptible to disease for a longer time period no evidence for benefit; unknown effect on no evidence for benefit; unknown effect on

efficacyefficacy increased opportunities for known side effectsincreased opportunities for known side effects some single-ingredient vaccines not availablesome single-ingredient vaccines not available extra visits = extra time and costextra visits = extra time and cost

Isn’t natural immunity Isn’t natural immunity better?better?

YES...YES... immunity after disease follows a immunity after disease follows a

single infection; vaccine immunity single infection; vaccine immunity may require several doses, and/or may require several doses, and/or boostersboosters

Isn’t natural immunity Isn’t natural immunity better?better?

……and NOand NO the cost is pain, discomfort and the the cost is pain, discomfort and the

potential for complications, disability, deathpotential for complications, disability, death vaccines are one of the safest most effective vaccines are one of the safest most effective

disease prevention tools knowndisease prevention tools known

worldwide most deaths from worldwide most deaths from vaccine-preventable diseases occur vaccine-preventable diseases occur in children with healthy immune in children with healthy immune systemssystems

for some diseases immunity from for some diseases immunity from vaccine is superiorvaccine is superior

What about my right to What about my right to decide? The Law in North decide? The Law in North

Carolina Carolina GS 130A-152(a): Every child in this state GS 130A-152(a): Every child in this state

shall be immunized… Parent shall have shall be immunized… Parent shall have the responsibility…the responsibility…

GS 130A-155(a): No child shall attend GS 130A-155(a): No child shall attend school, whether public, private, or school, whether public, private, or religious, or a child care facility unless religious, or a child care facility unless [immunized]…The principal or operator [immunized]…The principal or operator shall not permit the child to attendshall not permit the child to attend

GS 130A-155.1: No person shall attend GS 130A-155.1: No person shall attend college…unless [immunized]college…unless [immunized]

School AttendanceSchool Attendance

Required vaccinesRequired vaccines Diphtheria, tetanus, pertussis – 5 dosesDiphtheria, tetanus, pertussis – 5 doses

Tdap: 6Tdap: 6thth grade; Td booster within 10 yrs: grade; Td booster within 10 yrs: collegecollege

Polio – 4 dosesPolio – 4 doses Measles, Mumps – 2 dosesMeasles, Mumps – 2 doses Rubella – 1 doseRubella – 1 dose Varicella – 1 doseVaricella – 1 dose Hepatitis B – 3 dosesHepatitis B – 3 doses H. influenzae B – 4 (3) dosesH. influenzae B – 4 (3) doses

NCAC 41A .0401

ExemptionsExemptions

Medical (NC 130A-156)Medical (NC 130A-156) Religious (130A-157)Religious (130A-157)

There is no exception to these requirements for the case of a

personal belief or philosophy or a parent or guardian not

founded upon a religious belief. NCAC 41A .0401

Medical ExemptionMedical Exemption permitted when a physician determines permitted when a physician determines

that an immunization may be harmfulthat an immunization may be harmful must be written and signed by a NC must be written and signed by a NC

licensed physicianlicensed physician must correspond to medical must correspond to medical

contraindications specified in NC contraindications specified in NC Immunization rules, Immunization rules, oror receive an receive an approved exception from the State Health approved exception from the State Health DirectorDirector

must maintain documentation in student’s must maintain documentation in student’s permanent recordpermanent record

Religious ExemptionReligious Exemption

““bona fide religious objection”bona fide religious objection” no form for requesting religious no form for requesting religious

exemption in North Carolinaexemption in North Carolina parent must provide a written, signed parent must provide a written, signed

statement of the bona fide beliefs and statement of the bona fide beliefs and their opposition to immunization in the their opposition to immunization in the student’s permanent recordstudent’s permanent record not required to be notarized, signed by a not required to be notarized, signed by a

religious leader, prepared by an attorney, or religious leader, prepared by an attorney, or submitted to the state for reviewsubmitted to the state for review

Religious Objection to Religious Objection to VaccinesVaccines

Member of a religion that prohibits Member of a religion that prohibits vaccinationvaccination Christian ScienceChristian Science

Fetal tissuesFetal tissues some vaccines are made in human cell some vaccines are made in human cell

line cultures; some cell-line cultures line cultures; some cell-line cultures originated from aborted fetal tissue originated from aborted fetal tissue obtained from legal therapeutic obtained from legal therapeutic abortion in the 1960’sabortion in the 1960’s

Porcine additivesPorcine additives Islamic and Jewish lawIslamic and Jewish law

Compulsory vs Compulsory vs MandatoryMandatory

compulsory: people who refuse are compulsory: people who refuse are forcibly vaccinatedforcibly vaccinated right to refuse?right to refuse?

mandatory: people who refuse are mandatory: people who refuse are denied social privileges (like denied social privileges (like attending school)attending school) right to impose the risk on others?right to impose the risk on others?

Offit. Deadly Choices. 2011

Are Vaccines Safe?Are Vaccines Safe?

No vaccine (and no medication) is completely risk No vaccine (and no medication) is completely risk freefree common mild side effects: pain, tenderness, rednesscommon mild side effects: pain, tenderness, redness rare, serious side effects: anaphylaxis, rare, serious side effects: anaphylaxis,

thrombocytopeniathrombocytopenia Act of commission or omission: active or passive Act of commission or omission: active or passive

role? role? Because vaccines are given to healthy children, Because vaccines are given to healthy children,

they must be as safe as possible: they must be as safe as possible:

Benefit must clearly outweigh riskBenefit must clearly outweigh risk

Benefit vs. Risk:Benefit vs. Risk:Hepatitis BHepatitis B

Risk: Risk: anaphylaxis: 1 in 600,000anaphylaxis: 1 in 600,000 no reported deathsno reported deaths

Benefit: Benefit: 5000 deaths/yr; 10,000 with cirrhosis or cancer5000 deaths/yr; 10,000 with cirrhosis or cancer severe and fatal consequences more common in severe and fatal consequences more common in

the youngthe young 1 million people in US infected and 1 million people in US infected and

asymptomaticasymptomatic prior to vaccine, 18,000 children/yr in US prior to vaccine, 18,000 children/yr in US

caught Hepatitis B from someone other than caught Hepatitis B from someone other than their motherstheir mothers

Benefit vs Risk: Benefit vs Risk: RotavirusRotavirus

Risk (RotaShield):Risk (RotaShield): 1 million children vaccinated1 million children vaccinated 102 cases of intussusception: 1 in 10,000102 cases of intussusception: 1 in 10,000 1 death1 death

BenefitBenefit US: 100,000 hospitalizations, 50-100 US: 100,000 hospitalizations, 50-100

deaths/yeardeaths/year per million children: 16,000 hospitalizations, 5-10 per million children: 16,000 hospitalizations, 5-10

deathsdeaths most important cause of life-threatening most important cause of life-threatening

diarrhea worldwidediarrhea worldwide >870,000 children under 5 years die each year>870,000 children under 5 years die each year

Change in risk/benefitChange in risk/benefit

Monitoring for SafetyMonitoring for Safety

Pre-licensure testingPre-licensure testing Post licensure monitoringPost licensure monitoring Lot testingLot testing Vaccine Adverse Event Reporting Vaccine Adverse Event Reporting

System (VAERS)System (VAERS) Clinical Immunization Safety Clinical Immunization Safety

Assessment Centers (CISA)Assessment Centers (CISA) Vaccine Safety Datalink (VSD)Vaccine Safety Datalink (VSD)

Vaccines are not completely Vaccines are not completely safe, but they are as safe as we safe, but they are as safe as we can make them, far safer than can make them, far safer than most medications, and better most medications, and better

than the diseases they preventthan the diseases they prevent

Can vaccines cause Can vaccines cause chronic diseases like…chronic diseases like… infantile spasms? (pertussis)infantile spasms? (pertussis) autism? (measles/MMR)autism? (measles/MMR) diabetes? (Hib, BCG)diabetes? (Hib, BCG) allergies and asthma? (pertussis, tetanus)allergies and asthma? (pertussis, tetanus) multiple sclerosis (Hep B, influenza, multiple sclerosis (Hep B, influenza,

tetanus)tetanus) hemolytic anemia (DTP)hemolytic anemia (DTP) brain damage (polio, Hep B)brain damage (polio, Hep B) ITP (Hep B)ITP (Hep B) chronic arthritis (Hep B, Lyme)chronic arthritis (Hep B, Lyme) SIDS? (Hep B, pertussis)SIDS? (Hep B, pertussis)

                                                                                                                     

                                           

Vaccines and Chronic Vaccines and Chronic DiseaseDisease

Concerns arise because:Concerns arise because: children receive many vaccines during the first 2 yearschildren receive many vaccines during the first 2 years most children in the US are vaccinatedmost children in the US are vaccinated therefore most US children who develop chronic disease therefore most US children who develop chronic disease

during childhood have received vaccines (often recently)during childhood have received vaccines (often recently) BUT:BUT:

sequence sequence consequence consequence not all potential associations have been studied but not all potential associations have been studied but

many havemany have multiple independent studies have shown no link multiple independent studies have shown no link

between chronic disease and vaccinesbetween chronic disease and vaccines no noted trend for an increase or decrease in a disease no noted trend for an increase or decrease in a disease

as vaccination increases or decreases over timeas vaccination increases or decreases over time

MMR and AutismMMR and Autism

Honda H, Shimizu Y, Rutter M. J Child Psych 2005.

Hepatitis B and SIDSHepatitis B and SIDS

                                                

    

Refuting EvidenceRefuting Evidence When disease follows vaccination, it occurs When disease follows vaccination, it occurs

with a rate that can be predicted by chance with a rate that can be predicted by chance alonealone

Cohort and case-control studies show no Cohort and case-control studies show no evidence of causality between vaccines and evidence of causality between vaccines and chronic diseasechronic disease

In some cases, vaccines are probably In some cases, vaccines are probably protective against these diseasesprotective against these diseases

Practitioners must be aware of popular media, Practitioners must be aware of popular media, public health information, and changing public health information, and changing

recommendations, and have access to valid recommendations, and have access to valid alternative sources of information for parents.alternative sources of information for parents.

What About Other What About Other Ingredients in Vaccines?Ingredients in Vaccines?

preservativespreservatives adjuvantsadjuvants stabilizing additivesstabilizing additives manufacturing residualsmanufacturing residuals

antibioticsantibiotics formaldehydeformaldehyde egg proteinegg protein yeastyeast

Additives are present in very small Additives are present in very small amounts, but each is present for a reasonamounts, but each is present for a reason

Preservatives: thimerosalPreservatives: thimerosal mercury-based preservative used since 1930’smercury-based preservative used since 1930’s methylmercury is neurotoxic; vaccines methylmercury is neurotoxic; vaccines

contained ethylmercurycontained ethylmercury FDA modernization act of 1997: assess Hg FDA modernization act of 1997: assess Hg

content of all food and drugscontent of all food and drugs no distinction made between ethyl- and no distinction made between ethyl- and

methylmercurymethylmercury no adverse effects EVER attributed to vaccine no adverse effects EVER attributed to vaccine

thimerosalthimerosal except for some formulations of influenza, no except for some formulations of influenza, no

routine pediatric vaccines in US now contain routine pediatric vaccines in US now contain thimerosal thimerosal

Adjuvants: aluminumAdjuvants: aluminum

adjuvants enhance the immune responseadjuvants enhance the immune response aluminum salts only adjuvant in aluminum salts only adjuvant in

childhood vaccines in USchildhood vaccines in US aluminum is ubiquitous in the aluminum is ubiquitous in the

environment: a major component of the environment: a major component of the earth’s crush, and found in air, food, earth’s crush, and found in air, food, and water. and water. breastmilk and formula contain aluminumbreastmilk and formula contain aluminum

safety well establishedsafety well established

Stabilizers: gelatinStabilizers: gelatin

stabilizers protect viruses from adverse stabilizers protect viruses from adverse conditions (freeze drying, heat)conditions (freeze drying, heat)

all gelatin in vaccines is porcineall gelatin in vaccines is porcine risk of allergic reactionrisk of allergic reaction

most common identifiable cause of acute most common identifiable cause of acute hypersensitivity reaction to vaccineshypersensitivity reaction to vaccines

extremely low, 1 in 2 million dosesextremely low, 1 in 2 million doses history of allergy to foods containing gelatin history of allergy to foods containing gelatin

is a contraindication to vaccines with is a contraindication to vaccines with gelatingelatin

AntibioticsAntibiotics

antibiotics prevent bacterial antibiotics prevent bacterial contamination during manufacturing contamination during manufacturing processprocess

neomycin, polymyxin B, streptomycin, neomycin, polymyxin B, streptomycin, gentamicin; only neomycin is contained gentamicin; only neomycin is contained in vaccines in detectable quantitiesin vaccines in detectable quantities never clearly found to cause allergic never clearly found to cause allergic

reaction to vaccinationreaction to vaccination reaction is delayed type hypersensitivity: reaction is delayed type hypersensitivity:

SQ noduleSQ nodule

FormaldehydeFormaldehyde used to detoxify, sterilize used to detoxify, sterilize essential metabolite for DNA synthesis, but essential metabolite for DNA synthesis, but

known to damage DNA in high concentrationsknown to damage DNA in high concentrations all humans have detectable formaldehyde in all humans have detectable formaldehyde in

bloodblood causes cancerous changes in cells in the lab; causes cancerous changes in cells in the lab;

nevernever shown to be a cause of cancer in man shown to be a cause of cancer in man diluted during manufacture, but residual diluted during manufacture, but residual

amounts found in some vaccinesamounts found in some vaccines amount in vaccines considered safeamount in vaccines considered safe

Egg ProteinEgg Protein

egg allergy occurs in 0.5% of all kids egg allergy occurs in 0.5% of all kids and 5% of atopic kidsand 5% of atopic kids

influenza and yellow fever vaccines influenza and yellow fever vaccines contain egg proteincontain egg protein if anaphylaxis to egg, vaccine is if anaphylaxis to egg, vaccine is

contraindicatedcontraindicated MMR does MMR does not not contain eggcontain egg

YeastYeast

Hepatitis B made in Baker’s yeastHepatitis B made in Baker’s yeast anaphylaxis occurs rarely after anaphylaxis occurs rarely after

HepB vaccination (1 in 600,000)HepB vaccination (1 in 600,000) allergy to yeast allergy to yeast notnot apparently the apparently the

causecause IgE to yeast never found in a recipientIgE to yeast never found in a recipient

These are These are NOT NOT in in vaccines...vaccines...

antifreezeantifreeze aborted human fetus cellsaborted human fetus cells chick embryoschick embryos monkey kidneysmonkey kidneys fetal bovine serumfetal bovine serum

Learn more about additives: vaccine.chop.edu.

Sources for Sources for Vaccine Safety Vaccine Safety

InformationInformation Vaccine Education Center – CHOPVaccine Education Center – CHOP

vaccine.chop.eduvaccine.chop.edu Institute for Vaccine Safety – Johns HopkinsInstitute for Vaccine Safety – Johns Hopkins

www.vaccinesafety.eduwww.vaccinesafety.edu Vaccine Safety and Adverse Events – CDCVaccine Safety and Adverse Events – CDC

www.cdc.gov/vaccinesafety/www.cdc.gov/vaccinesafety/ Vaccine Safety Info for Families – AAP Vaccine Safety Info for Families – AAP

www.aap.org/immunization/families/safety.htmlwww.aap.org/immunization/families/safety.html

An Approach to the An Approach to the Parent Who Refuses Parent Who Refuses

Vaccines…Vaccines… ListenListen Acknowledge fears, and parents’ right to Acknowledge fears, and parents’ right to

decidedecide Identify specific concerns, and provide a Identify specific concerns, and provide a

targeted, accurate responsetargeted, accurate response State your recommendation clearly, but State your recommendation clearly, but

be nonconfrontational. be nonconfrontational. Avoid scientific lecturesAvoid scientific lectures Recommend valid websites and booksRecommend valid websites and books

If parents still refuse?If parents still refuse?

Voice respect for their opinionVoice respect for their opinion Agree to readdress at future visitsAgree to readdress at future visits Give Give somesome vaccines if you can vaccines if you can Document discussion in the Document discussion in the

healthcare record, and status in NCIRhealthcare record, and status in NCIR Remember: All children deserve Remember: All children deserve

quality medical carequality medical care

SummarySummary Many parents have questions or concerns about Many parents have questions or concerns about

childhood vaccines. childhood vaccines. Most parents have great faith in their child’s Most parents have great faith in their child’s

providerprovider Most parents readily accept recommendations Most parents readily accept recommendations

about vaccinationabout vaccination Most parents weigh risk and benefit, and Most parents weigh risk and benefit, and

determine that vaccines are right for their child determine that vaccines are right for their child and for societyand for society

When parents are concerned about vaccines, we When parents are concerned about vaccines, we must find out why and address their concernsmust find out why and address their concerns