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Putting Vaccine Benefits and Risks into Perspective for Patients and Parents

Putting Vaccine Benefits and Risks into Perspective for Patients and Parents. Material authored by: Gary S. Marshall, MD Professor of Pediatrics Chief, Division of Pediatric Infectious Diseases Director, Pediatric Clinical Trials Unit University of Louisville School of Medicine

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Putting Vaccine Benefits and Risks into Perspective for Patients and Parents

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  1. Putting Vaccine Benefits and Risks into Perspective for Patients and Parents Material authored by: Gary S. Marshall, MD Professor of Pediatrics Chief, Division of Pediatric Infectious Diseases Director, Pediatric Clinical Trials Unit University of Louisville School of Medicine Louisville, Kentucky

  2. From Fear of Disease to Fear of Adverse Events Salk J. Pediatr Infect Dis J. 1987;6:889-893. Infectious Disease News; November, 1998.

  3. A Sampling of Anti-Vaccine Groups National Vaccine Information Center Generation Rescue Concerned Parents For Vaccine Safety Citizens for Healthcare Freedom Vaccine Information Resource Center PAVE: People Advocating Vaccine Education Future Generations Vaccination Alternatives Natural Immunity Information Network Age of Autism Healthy Alternatives The Canary Party Safe Minds ThinkTwice Global Vaccine Institute Marshall GS. The Vaccine Handbook. PCI Books, Inc.; 2012.

  4. Who Are the Vaccine Protestors? Smith PJ, et al. Pediatrics 2004;114:187-195.

  5. Immunization Truths 1. Vaccines are good for public health

  6. Vaccine Programs Initiated Before 1980 Roush SW, et al. JAMA. 2007;298:2155-2163.

  7. Vaccine Programs Initiated After 1980 †Estimates Roush SW, et al. JAMA. 2007;298:2155-2163.

  8. Impact of Childhood Vaccinations Coffield AB, et al. Am J Prev Med. 2001;21:1-9.

  9. Impact of Childhood Vaccinations †DTaP, Hib, IPV, MMR, HepB, varicella (not included: rotavirus, HepA, PCV-7, influenza, MCV-4, HPV) $1 spent = $5 in direct medical costs $11 in societal costs Zhou F, et al. Arch Pediatr Adolesc Med. 2005;159:1136-1144.

  10. Immunization Truths 1. Vaccines are good for public health 2. Public concern about vaccines is pervasive

  11. Parental Concerns About Vaccines Freed GL, et al. Pediatrics. 2010;125:654-659.

  12. Public Concern Is Pervasive Newsweek. July 31, 2000 Time. June 2, 2008

  13. Immunization Truths 1. Vaccines are good for public health 2. Public concern about vaccines is pervasive 3. Fear of vaccines can lead to public harm

  14. Incidence of Pertussis: England and Wales Vaccine uptake 500 81% 93% 31% Incidence per 100,000 0 1940 1990 1965 Gangarosa EJ, et al. Lancet. 1998;351:356-361.

  15. Case Control Studies Data from Kaiser Permanente, Colorado (1996-2008) Glanz JM, et al. Pediatrics. 2009;123:1446-1451. Glanz JM, et al. Arch Pediatr Adol Med. 2010;164:66-70.

  16. 2000 2010 Wakefield AJ, et al. Lancet. 1998;351:637-641.

  17. MMR and Autism: United Kingdom Annual Birth Cohort Kaye JA, et al. Br Med J. 2001;322:460-463.

  18. MMR and Autism: California Dales L, et al. JAMA. 2001;285:1183-1185.

  19. Danish Cohort Study The Past MMR 1,647,504 person-yr No MMR 482,360 person-yr Children born between 01/01/91 and 12/31/98 Population of Denmark Madsen KM, et al. N Engl J Med. 2002;347:1477-1482.

  20. Danish Cohort Study The Past The Present MMR 1,647,504 person-yr Autism: 263 ASD: 345 No MMR 482,360 person-yr Autism: 53 ASD: 77 Children born between 01/01/91 and 12/31/98 Population of Denmark Madsen KM, et al. N Engl J Med. 2002;347:1477-1482.

  21. Danish Cohort Study The Past The Present MMR 1,647,504 person-yr Autism: 263 ASD: 345 No MMR 482,360 person-yr Autism: 53 ASD: 77 Relative risk: Autism: 0.92 (0.68-1.24) ASD: 0.83 (0.65-1.07) Children born between 01/01/91 and 12/31/98 Population of Denmark Madsen KM, et al. N Engl J Med. 2002;347:1477-1482.

  22. 2000 2010 Murch SH, et al. Lancet. 2004;363:750.

  23. 2000 2010 General Medical Council, 2010. http://www.gmc-uk.org/Wakefield_SPM_and_ SANCTION.pdf_32595267.pdf. Accessed March 2012.

  24. 2000 2010 Editorial. Lancet. 2010;375:445.

  25. Consequences of Public Fear Wakefield paper 92 2,000 90 1,800 88 1,600 86 1,400 84 1,200 MMR Vaccine Coverage (%) Confirmed Measles Cases in England and Wales 82 1,000 80 800 78 600 76 400 74 200 72 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Leask J. Nature. 2011;473;443-445. Editorial Team. Eurosurveillance. http://www.eurosurveillance.org/viewarticle.aspx?articleid=18919. Accessed March 2012.

  26. Immunization Truths 1. Vaccines are good for public health 2. Public concern about vaccines is pervasive 3. Fear of vaccines can lead to public harm 4. Vaccines are not 100% safe

  27. Restoring Public Confidence Pre-Clinical Center for Biologics Evaluation and Research Good Manufacturing, Laboratory and Clinical Practices Phased clinical trials Marshall GS. The Vaccine Handbook. PCI Books, Inc.; 2012.

  28. Restoring Public Confidence Licensure and Recommendation Pre-Clinical Center for Biologics Evaluation and Research Good Manufacturing, Laboratory and Clinical Practices Phased clinical trials FDA ACIP AAP AAFP Marshall GS. The Vaccine Handbook. PCI Books, Inc.; 2012.

  29. Restoring Public Confidence Licensure and Recommendation Pre-Clinical Post-Marketing Center for Biologics Evaluation and Research Good Manufacturing, Laboratory and Clinical Practices Phased clinical trials FDA ACIP AAP AAFP Phase 4 studies Pharmacovigilance Vaccine Adverse Event Reporting System Vaccine Safety Datalink CISA Network Brighton Collaboration Ad-hoc committees Marshall GS. The Vaccine Handbook. PCI Books, Inc.; 2012.

  30. How Many Subjects are Needed To Detect Adverse Events? Assumes 5% risk of Type I error and power of 90% Evans D, et al. J Infect Dis. 2009;200:321-328.

  31. Immunization Truths 1. Vaccines are good for public health 2. Public concern about vaccines is pervasive 3. Fear of vaccines can lead to public harm 4. Vaccines are not 100% safe 5. Parents are human

  32. The Power of Box “a” Offit PA. Immunization Action Coalition Web site. http://www.immunize.org/safety/boxa.pdf. Accessed March 2012.

  33. The Power of Box “a” Offit PA. Immunization Action Coalition Web site. http://www.immunize.org/safety/boxa.pdf. Accessed March 2012.

  34. Folk Numeracy 10,000,000 women get a shot 86 develop optic neuritis 6 weeks later 10,000,000 pregnant women get a shot 16,684 have aspontaneous abortion 6 weeks later Shermer M. Sci Amer. http://www.scientificamerican.com/article.cfm?id=why-our- brains-do-not-intuitively-grasp-probabilities. AccessedJanuary 2012. Black S, et al. Lancet. 2009;374:2115-2122.

  35. Folk Numeracy 10,000,000 women get a shot 86 develop optic neuritis 6 weeks later 10,000,000 pregnant women get a shot 16,684 have aspontaneous abortion 6 weeks later If the shot is a placebo! Shermer M. Sci Amer. http://www.scientificamerican.com/article.cfm?id=why-our- brains-do-not-intuitively-grasp-probabilities. AccessedJanuary 2012. Black S, et al. Lancet. 2009;374:2115-2122.

  36. Immunization Truths 1. Vaccines are good for public health 2. Public concern about vaccines is pervasive 3. Fear of vaccines can lead to public harm 4. Vaccines are not 100% safe 5. Parents are human 6. People don’t understand vaccinology

  37. 1982 1 mo 2 mos 4 mos 6 mos 12 mos 15 mos 18 mos 24 mos 4-6 yrs 11-12 yrs 14-18 yrs Age Birth Vaccine Diphtheria, Tetanus, Pertussis Td DTP DTP DTP DTP DTP OPV OPV (OPV) OPV OPV Polio Measles, Mumps, Rubella MMR Childhood Schedule, 1982

  38. Childhood Schedule, 2012

  39. Antigen Burden Offit P. Pediatrics. 2002;109:124-129 Marshall GS. The Vaccine Handbook. PCI Books: 2012.

  40. Alternative Vaccine Schedule Sears RW. The Vaccine Book. Little Brown & Co. 2007.

  41. Alternative Vaccine Schedule Offit P, Moser C. Pediatrics. 2009;123:e164.

  42. Immunization Truths 1. Vaccines are good for public health 2. Public concern about vaccines is pervasive 3. Fear of vaccines can lead to public harm 4. Vaccines are not 100% safe 5. Parents are human 6. People don’t understand vaccinology 7. It’s all about risk perception

  43. Risk Perception Kalb C, et al. Newsweek. 2010;155(22).

  44. Estimated Annual Mortality in the US

  45. Immunization Truths 1. Vaccines are good for public health 2. Public concern about vaccines is pervasive 3. Fear of vaccines can lead to public harm 4. Vaccines are not 100% safe 5. Parents are human 6. People don’t understand vaccinology 7. It’s all about risk perception 8. There are vaccine anti-champions

  46. US Weekly. Oct 27, 2008

  47. Thimerosal

  48. Danish Population-Based Study Thimerosal-containing vaccines removed Madsen KM, et al. Pediatrics. 2003;112:604-606.

  49. Autism in California 4.5 Age of Children, y 12 4.0 8 4 7 x 11 3 6 10 2 3.5 5 9 3.0 2.5 Cases per 1000 Live Births 2.0 1.5 1.0 0.5 x x x x x x x x x x x 0 1989 1991 1993 1995 1997 1999 2001 2002 2003 Year of Birth Adapted from Schechter R, Grether J. Arch Gen Psychiatry. 2008;65:19-24.

  50. Thimerosal in Vaccines FDA. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ UCM096228#t1. Accessed March 2012.

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