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

  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

  4. Smallpox Diphtheria Measles Mumps Pertussis Polio (Paralytic) Rubella Congenital Rubella Syndrome Tetanus Haemophilusinfluenzae 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% Vaccine Preventable Diseases in the US 20th Century 2007 Reported Percent Disease Annual Morbidity†Cases††Decrease

  5. 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% Incidence / 100,000 1998 1999 2000 2001 2002 2003 2004 2005 2006 Community Effects of Immunization: invasive vaccine associated pneumococcal disease in adults Year

  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?

  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

  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 *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% Omer SB. NEJM 2009;360:1981

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

  12. Parents with objections to vaccines in Vermont

  13. Parental attitudes toward vaccines (N=1552) 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 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

  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

  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 *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 harm 69% • Overwhelm the immune system 49% • Child not at risk for disease 37% • Disease not serious 21% Salmon DA. ArchPediatrAdolesc Med 2005;159:470-476 Bardenheier B. Arch PediatrAdolesc Med 2004;158:569-575 Gust DA. Pediatrics 2008;122: 718-725

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

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

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

  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

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

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

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

  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

  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

  28. No Need for Vaccines 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

  30. Lack of Efficacy 3 unimmunized 1 death 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

  32. Overwhelming the immune system 1012 B cell epitopes 1018 T cell epitopes 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 Dermatology Atlas on Line

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

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

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

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

  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

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

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

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

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

  44. Main reasons parents who planned to delay or not get a vaccine changes their mind 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 *Ed Marcuse; University of Washington. Personal communication

  46. National Campaign • Social Marketing • Evidence based • Targeted • Independent of vaccine manufacturer influences 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