Vaccine RefusalVaccine Refusal

William V. Raszka, Jr., MDUniversity of Vermont College of Medicine

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2

DisclosureDisclosure• Neither I nor any member of my immediate family has a

financial relationship or interest (currently or within the past 12 months) with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

• The opinions presented are my own and do not necessarily reflect those of Fletcher Allen Health Care, University of Vermont College of Medicine, or the Vermont Children’s Hospital

• No unapproved use of pharmaceutical agents are discussed

ObjectivesObjectives

• Describe the epidemiology of vaccine concerns

• Review the reasons for vaccine concerns or refusal

• Analyze the data on vaccine safety• Discuss means to allay parental concerns

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Smallpox

Diphtheria

Measles

Mumps

Pertussis

Polio (Paralytic)

Rubella

Congenital Rubella Syndrome

Tetanus

Haemophilus influenzae

29,005

21,053

530,217

162,344

200,752

16,316

47,745

152

580

20,000

0

0

43

800

10,454

0

12

0

28

202*

100%

100%

>99%

>99%

95%

100%

>99%

100%

95%

99%

20th Century 2007 Reported PercentDisease Annual Morbidity† Cases†† Decrease

Vaccine Preventable Diseases in the Vaccine Preventable Diseases in the USUS

4

Year

70

60

50

40

30

20

10

0

PCV7 licensed

≥80 yo: -90%65-79 yo: -88%50-64 yo: -80%18-49 yo: -88%

1998 1999 2000 2001 2002 2003 2004 2005 2006

Inci

denc

e /

100,

000

Community Effects of Immunization: invasive vaccine Community Effects of Immunization: invasive vaccine associated pneumococcal disease in adultsassociated pneumococcal disease in adults

5

6MMWR 2009;58:921

Vaccine RefusalVaccine Refusal

• How many of you have personal experience with someone who has deferred at least one vaccine?

• How many of you have personal experience with someone who has refused at least one vaccine?

• How many of you have personal experience with someone who has refused all vaccines?

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Vaccine Refusal: Scope of the problemVaccine Refusal: Scope of the problem

• 2004:– 92% report at least one vaccine refusal in past

year*– 50% had a family refuse all vaccines^

• 2006– 2-3% refuse vaccines^^

• 2008– 20% defer or refuse some vaccines**

*Freed JL. Am J Prev Med 2004^Flanagan-Klygis EA. Arch Pediatr Adolesc Med 2005**Gust DA Pediatrics 2008^^Omer SB. JAMA 2006;296:1757

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Vaccine Refusal: Scope of the ProblemVaccine Refusal: Scope of the Problem

• 2010*– 2921 parents of 19-35 month old children– 21.8% delayed a vaccine

• 2011^– 11,206 parents of 24-35 month old children– 25.8% delayed a vaccine– 8.2% refused a vaccine– 5.8% delayed and refused a vaccine

9*Smith PJ. Public Health Rep 2010;125:534^Smith PJ. Public Health Rep 2011;126 (Suppl 2):135

Vaccine Refusal Rates:Vaccine Refusal Rates:1991-20041991-2004

• Mean state wide non medical exemptions– Rates rose from 0.98%-1.48%

• Among states with religious exemptions– Rates steady at 1%

• Among states with philosophical exemptions– Rate rose from .99% to 2.54%

10Omer SB. NEJM 2009;360:1981

Washington State Immunization Washington State Immunization Exemption Rates by School District; 2008-Exemption Rates by School District; 2008-

0909

11www.doh.wa.gov/cfh/Immunize/

Parents with objections to vaccines in Parents with objections to vaccines in VermontVermont

 County

# Practices Total Patients Total Patientsw/ Objection

% Patientsw/ Objection

Addison 3 4171 76 1.8%

Bennington 4 3915 53 1.4%

Caledonia 2 4724 32 0.7%

Chittenden 9 14719 151 1.0%

Franklin/Grand Isle 4 2114 20 0.9%

Orange 5 4102 15 0.4%

Orleans 4 1387 10 0.7%

Rutland 2 2040 7 0.3%

Washington 3 2314 43 1.9%

Windham 7 4625 21 0.5%

Windsor 1 341 7 2.1%

Parental attitudes toward vaccines Parental attitudes toward vaccines (N=1552)(N=1552)

Perspective % Agree

Getting vaccines protects my children from disease 90

I generally do what my doctor recommends about vaccines 88

I am concerned about serious adverse effects of vaccines 54

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

51

Parents should be able to refuse vaccines for any reason 31

Some vaccines cause autism in healthy children 25

I have refused at least one vaccine 11

13Freed GL Pediatrics 2010;125;654-659

Parents With Doubts About VaccinesParents With Doubts About Vaccines

• At least one vaccine concern (28.1%)– Unsure: vaccinated their child although they were

not sure it was the best thing to do (8.9%)– Delayed a vaccination (13.4%)– Refused: to get a vaccination (6.0%)

• Concerns associated with increased age, income, and education

• Varicella vaccine and no specific vaccine gave the greatest concern

14Gust DA. Pediatrics. 2008 Oct;122:718-25

Reasons for increasing parental Reasons for increasing parental concern and vaccine refusalconcern and vaccine refusal

• Vaccines are given to healthy children– Perceived risk of disease has diminished– Acceptable risk associated with the vaccine has

diminished• Safety is relative not absolute

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Reasons for increasing refusalReasons for increasing refusal

• Different definitions of causality– Medical – Legal– Cannot prove no association between a vaccine and an adverse event exists

• Power of the anecdote over science

Insert video

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Physician response to vaccine refusalPhysician response to vaccine refusal

• What should be done?• 2005*– 1004 Pediatricians• 54% faced vaccine refusal• 39% would dismiss from practice

• 2011^– 133 pediatricians in CT• >30% have dismissed

17*Flanagan-Klygis. Arch Pediatr Adolesc Med 2005;159:929^Leib S. Publ Health Rec 2011;126 (suppl 2):13

Parental Concerns about VaccinesParental Concerns about Vaccines

• Vaccines – Cause harm 69%– Overwhelm the immune system 49%

• Child not at risk for disease 37%• Disease not serious 21%

Salmon DA. Arch Pediatr Adolesc Med 2005;159:470-476 Bardenheier B. Arch Pediatr Adolesc Med 2004;158:569-575Gust DA. Pediatrics 2008;122: 718-725

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Autism Prevalence Rates (ages 6-17)Autism Prevalence Rates (ages 6-17)

19US Department of Education

MMR and Autism Rates in CanadaMMR and Autism Rates in CanadaPr

eval

ence

/10,

000

Year of birth

100

MM

R co

vera

ge ra

te

Fombonne E. Pediatrics 2006;118;e139-e15020

MMR and Autism in JapanMMR and Autism in Japan

Honda J. J Child Psych and Psychiatry 46:6 (2005), pp 572–57921

Measles (MMR) and AutismMeasles (MMR) and Autism

• Institute of Medicine – Rejects an association

• National Vaccine Compensation Board– Rejects an association

Institute of Medicine. Immunization Safety Review: Vaccines and Autism 2004 22

Autism and ThimerosalAutism and Thimerosal

• Thimerosal– A preservative in vaccines– 50% mercury– Metabolized to ethyl mercury

• Organic mercury toxicity– Central nervous system– Fetal>neonatal>adult

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US Department of EducationSchechter R. Arch Gen Psychiatry. 2008;65:19-24

Autism and Thimerosal: USAAutism and Thimerosal: USA

24

25

Inci

denc

e pe

r 10,

000

Stehr-Green. Am J Prev Med 2003;25:101

Removal of thimerosal

Thimerosal and Autism: EuropeThimerosal and Autism: Europe

Thimerosal and Neurodevelopmental Thimerosal and Neurodevelopmental OutcomesOutcomes

• >1000 children– Various amounts of thimerosal

• No relationship between ethyl mercury exposure and neuropsychological outcomes at 7-10 years

Thompson WW. NEJM 2007;357:128126

Other Vaccine Ingredients Other Vaccine Ingredients

• Aluminum– 295-1225 µg in vaccines at two month visit– Soy formula: 450 to 930 µg/L

• Formaldehyde– Trace amounts– Less than usually detected in infants

• “Anti-freeze”– Polyethylene glycol in many products– Ethylene glycol

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No Need for VaccinesNo Need for Vaccines

28CDC

Measles in the US: Jan-July 2008

• 131 cases– 76% < 20 years old– 91% unvaccinated– 89% imported or

associated with importation

MMWR 2008;57(33):89329

Lack of Efficacy

– 3 unimmunized– 1 death

30CDCMMWR. January 23, 2009; 58:1-3

Distrust of GovernmentDistrust of Government

• Oral polio virus– Withdrew a highly successful vaccine

• Initial rotavirus vaccine– Identified area of concern– Monitored– Withdrew within 6 months

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Overwhelming the immune systemOverwhelming the immune systemYear Vaccine Proteins

1900 Smallpox 200

1960 Smallpox, diphtheria, tetanus, pertussis, polio

3217

1980 Diphtheria, tetanus, pertussis, polio, measles, mumps, rubella

3041

2000 Diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, Hib, varicella, pneumococcus, hepatitis B

125

1012 B cell epitopes1018 T cell epitopes

32Offit PA. Pediatrics 2002;109:124-129

Natural disease is either:Natural disease is either: a) better or b) not serious a) better or b) not serious

• Complications of VZV in the USA– 11,000 hospitalizations• Bacterial superinfections

– Encephalitis (1/100,000)– Ataxia (1/4000)– Congenital varicella (2%)– 100 deaths/year • 50% in children

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Dermatology Atlas on Line

Vaccine RequirementsVaccine Requirements

• The US is fairly unique in requiring vaccinations

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The state’s duty to protect the public healthvs.

An individuals right of free choice

Personal belief exemptions include religious, philosophical and any other unspecified non-medical exemption

Types of Vaccine Exemptions:Types of Vaccine Exemptions: 4/16/094/16/09

35www.vaccinesafety.edu/cc-exem.htm

All states allow for medical exemptions48 states allow for religious exemptionApproximately ½ allow for philosophical exemption

Background rate of exemptionsBackground rate of exemptions

Omer SB. JAMA 2006;296:1757

Exem

ption

rate

%

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CDC School Immunization Survey

DC

US

None Reported<1%

2.5-4.9%≥5%

1.0-2.4%

Immunization Exemption Rates:Immunization Exemption Rates: 2005-2006 School Year 2005-2006 School Year

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DCUS

None Reported<1%

2.5-4.9%≥5%

1.0-2.4%

Immunization Exemptions and Risk of DiseaseImmunization Exemptions and Risk of Disease

• Pertussis– States with philosophical exemptions:• 2.06 (1.8-2.4) rate over religious only*

– Individuals who refused immunizations:• 22.8 (6.7-77.5) risk of disease^

• Varicella– Refusal associated with 8.6 (2.2-33.3) risk of

disease**

*Omer SB. JAMA 2006;296:1757^Glanz JM. Pediatrics. 2009;123:1446-51**Glanz JM. Arch Pediatr Adolesc Med 2010:164:66

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Measles and Refusal to Vaccinate• Vancouver Olympics

– 2 Canadians, 1 American– 16 people in Vancouver

• ½ in one unvaccinated household

• San Diego 2008– Unvaccinated 7 year old acquired

measles in Switzerland– 839 exposed people

• 73 were unvaccinated children– 25 whose parents chose not to get

them vaccinated– 48 children under 12 months too

young to be vaccinated• 11 additional cases

– $10, 376/case– $775 per quarantined child

39Sugerman, DE. Pediatrics. 2010 Apr;125:747-55,

CDC vs. Dr. Bob’s alternative vaccine schedule

http://health.usnews.com

8 Additional visitsMMRV all separated and delayedHepatitis A and B delayedPolio delayed

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Dr. Bob’s Selective Vaccine ScheduleDr. Bob’s Selective Vaccine Schedule

tetanus

Seeselective

No: MMRV, Hep A or B, polio, influenza

41http://health.usnews.com

Problems with Selective Vaccine SchedulesProblems with Selective Vaccine Schedules

• Reinforce unfounded fears • Encourage parents to hide in the herd• Fail to distinguish between good and bad

science• Leave infants and children vulnerable to

vaccine-preventable disease• Add to implementation costs• Consume vast amounts of physician time

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PreventionPrevention

• Prenatal visits• Newborn nursery• First visits• Waiting room• Developing a trusting relationship– Listening and caring– Honesty and openness– Competence and expertise

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Main reasons parents who planned to delay or Main reasons parents who planned to delay or not get a vaccine changes their mindnot get a vaccine changes their mind

44Gust DA. Pediatrics. 2008 Oct;122:718-25

AAA Approach*AAA Approach*

• Ask:– Do you have any questions about vaccines?

• Acknowledge:– I know you want to do what is best for your child, so

do I! Many parents feel bombarded with conflicting information and do not know whom to believe

• Advise:– To help you make a fully informed decision about

immunizations, here are some science-based information sources, unrelated to drug companies

45*Ed Marcuse; University of Washington. Personal communication

National CampaignNational Campaign

• Social Marketing• Evidence based• Targeted• Independent of vaccine manufacturer

influences

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Associated with a cost

ConclusionsConclusions

• Parents risk-benefit view of vaccines has changed• Parents remain concerned about long term

neurologic sequelae of vaccines• Many parents want increased flexibility– At a cost of increased office visits– Increased physician time– Minimum availability of some single agent vaccines

• Prevention and patience may be key

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