1. Vaccine Refusal William V. Raszka, Jr., MD University of Vermont College of Medicine 1

2. 2 Disclosure 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

3. Objectives 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 3

4. 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 43 800 10,454 0 12 0 28 202* 100% >99% 95% 100% >99% 100% 95% 99% 20 th Century 2007 Reported Percent Disease Annual Morbidity† Cases†† Decrease Vaccine Preventable Diseases in the US 4

5. 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 Incidence / 100,000 Community Effects of Immunization: invasive vaccine associated pneumococcal disease in adults 5

6. 6 MMWR 2009;58:921

7. Vaccine 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? 7

8. Vaccine 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 8

9. Vaccine 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

10. Vaccine Refusal Rates: 1991-2004 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% 10 Omer SB. NEJM 2009;360:1981

11. Washington State Immunization Exemption Rates by School District; 2008-09 11 www.doh.wa.gov/cfh/Immunize/

12. Parents with objections to vaccines in Vermont County # PracticesTotal Patients w/ Objection % Patients w/ Objection Addison34171761.8% Bennington43915531.4% Caledonia24724320.7% Chittenden9147191511.0% Franklin/Grand Isle42114200.9% Orange54102150.4% Orleans41387100.7% Rutland2204070.3% Washington32314431.9% Windham74625210.5% Windsor134172.1%

13. Parental attitudes toward vaccines (N=1552) Perspective% Agree Getting vaccines protects my children from disease90 I generally do what my doctor recommends about vaccines88 I am concerned about serious adverse effects of vaccines54 New vaccines are recommended only if they are as safe as older ones 51 Parents should be able to refuse vaccines for any reason31 Some vaccines cause autism in healthy children25 I have refused at least one vaccine11 13 Freed GL Pediatrics 2010;125;654-659

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

15. Reasons for increasing parental concern 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 15

16. Reasons 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 16

17. Physician 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

18. Parental Concerns about Vaccines Vaccines – Cause harm69% – Overwhelm the immune system49% Child not at risk for disease37% Disease not serious21% Salmon DA. Arch Pediatr Adolesc Med 2005;159:470-476 Bardenheier B. Arch Pediatr Adolesc Med 2004;158:569-575 Gust DA. Pediatrics 2008;122: 718-725 18

19. Autism Prevalence Rates (ages 6-17) 19 US Department of Education

20. MMR and Autism Rates in Canada Prevalence/10,000 Year of birth 100 MMR coverage rate Fombonne E. Pediatrics 2006;118;e139-e150 20

21. MMR and Autism in Japan Honda J. J Child Psych and Psychiatry 46:6 (2005), pp 572–579 21

22. Measles (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

23. Autism and Thimerosal Thimerosal – A preservative in vaccines – 50% mercury – Metabolized to ethyl mercury Organic mercury toxicity – Central nervous system – Fetal>neonatal>adult 23

24. US Department of Education Schechter R. Arch Gen Psychiatry. 2008;65:19-24 Autism and Thimerosal: USA 24

25. 25 Incidence per 10,000 Stehr-Green. Am J Prev Med 2003;25:101 Removal of thimerosal Thimerosal and Autism: Europe

26. Thimerosal and Neurodevelopmental Outcomes >1000 children – Various amounts of thimerosal No relationship between ethyl mercury exposure and neuropsychological outcomes at 7-10 years Thompson WW. NEJM 2007;357:1281 26

27. 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 27

28. No Need for Vaccines 28 CDC

29. 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):893 29

30. Lack of Efficacy – 3 unimmunized – 1 death 30 CDC MMWR. January 23, 2009; 58:1-3

31. Distrust of Government Oral polio virus – Withdrew a highly successful vaccine Initial rotavirus vaccine – Identified area of concern – Monitored – Withdrew within 6 months 31

32. Overwhelming the immune system YearVaccineProteins 1900Smallpox200 1960Smallpox, diphtheria, tetanus, pertussis, polio 3217 1980Diphtheria, tetanus, pertussis, polio, measles, mumps, rubella 3041 2000Diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, Hib, varicella, pneumococcus, hepatitis B 125 10 12 B cell epitopes 10 18 T cell epitopes 32 Offit PA. Pediatrics 2002;109:124-129

33. Natural disease is either: 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 33 Dermatology Atlas on Line

34. Vaccine Requirements The US is fairly unique in requiring vaccinations 34 The state’s duty to protect the public health vs. An individuals right of free choice

35. Personal belief exemptions include religious, philosophical and any other unspecified non-medical exemption Types of Vaccine Exemptions: 4/16/09 35 www.vaccinesafety.edu/cc-exem.htm All states allow for medical exemptions 48 states allow for religious exemption Approximately ½ allow for philosophical exemption

36. Background rate of exemptions Omer SB. JAMA 2006;296:1757 Exemption rate% 36

37. CDC School Immunization Survey DC US None Reported <1% 2.5-4.9% ≥5% 1.0-2.4% Immunization Exemption Rates: 2005-2006 School Year 37 DC US None Reported <1% 2.5-4.9% ≥5% 1.0-2.4%

38. Immunization 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 38

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

40. CDC vs. Dr. Bob’s alternative vaccine schedule http://health.usnews.com 8 Additional visits MMRV all separated and delayed Hepatitis A and B delayed Polio delayed 40

41. Dr. Bob’s Selective Vaccine Schedule tetanus See selective No: MMRV, Hep A or B, polio, influenza 41 http://health.usnews.com

42. Problems 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 42

43. Prevention Prenatal visits Newborn nursery First visits Waiting room Developing a trusting relationship – Listening and caring – Honesty and openness – Competence and expertise 43

44. Main reasons parents who planned to delay or not get a vaccine changes their mind 44 Gust DA. Pediatrics. 2008 Oct;122:718-25

45. 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

46. National Campaign Social Marketing Evidence based Targeted Independent of vaccine manufacturer influences 46 Associated with a cost

47. Conclusions 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 47