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39 th National Immunization Conference Working with the Public on Vaccine Safety Washington, D.C. March 23, 2005

39 th National Immunization Conference Working with the Public on Vaccine Safety Washington, D.C. March 23, 2005. Educating Health Care Providers about Vaccine Safety Controversies. Thomas N. Saari, M.D., F.A.A.P. University of Wisconsin-Madison

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39 th National Immunization Conference Working with the Public on Vaccine Safety Washington, D.C. March 23, 2005

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  1. 39th National Immunization Conference Working with the Public on Vaccine SafetyWashington, D.C.March 23, 2005 Educating Health Care Providers about Vaccine Safety Controversies Thomas N. Saari, M.D., F.A.A.P. University of Wisconsin-Madison School of Medicine, Department of Pediatrics Division of Pediatric Infectious Disease

  2. Comparison of Maximum and Current Morbidity:Vaccine Preventable Diseases ( VPD) in the USA VPDMax CasesDeaths2002 Cases Diphtheria 206,939 13,1701 Pertussis 265,269 5099 9771 Tetanus 1,733 69325 Measles 894,134 7575 44 Mumps 152,209 270 Rubella 57,686 (~10,000 CRS*) 18( 1 CRS*) Polio 21,26918790 H. influenza b 20,00060034 Varicella 3.9 x 1061209 ( Deaths ) Hepatitis B 300,000 est 5200 20,000 est * Congenital Rubella Syndrome

  3. Vaccines and the provision of immunization services are now scrutinized more intensely than the diseases they are designed to prevent

  4. Expanding Vaccination Schedule Vaccine Shortages Immunization Advocacy Challenges

  5. Recommended Childhood Immunization Schedule: USA1 9 8 0 AGE Vaccine 4-6 yrs 14 -15 yrs 2 Mo 4 Mo 6 Mo 12 Mo 15 Mo 18Mo Diphtheria , Tetanus Toxoid, Pertussis DTwP DTwP DTwP DTwP DTwP dT Polio OPV OPV OPV OPV Measles, Mumps, Rubella MMR

  6. Range of recommended ages Catch-up vaccination Preadolescent assessment Recommended Childhood and Adolescent Immunization Schedule:United States 2007-8 Vaccine/ Age 4-6 yr 11-12 yr 13-18 yr Birth 1mo 2mo 4mo 6 mo 12 mo 15mo 18mo 24mo Hepatitis B HepB#1 HBsAg(-) mom Hep B Series HepB#2 HepB#3 dTaP Td Diphtheria, Tetanus, Pertussis DTaP DTaP DTaP DTaP DTaP Hib Hib Hib Hib H. flu B eIPV Inactivated Polio eIPV eIPV eIPV Measles Mumps Rubella, Varicella MMR-V#1 MMR-V#2 MMR-V#2 eIPV Pneumo Conj PCV13 PCV13 PCV13 PCV13 Influenza Influenza ( Yearly ) Influenza ( Yearly ) Meningococcal Conjugate MCV4 MCV4 Rotavirus ( PO ) RVV5 RVV5 RVV5 Hepatitis A Hepatitis A Series Human Papilloma Virus HPV PCV7 PPV Vaccines below this line are for select populations

  7. Expanding Vaccination Schedule Escalating Vaccine Costs Vaccine Shortages Immunization Advocacy Challenges

  8. Private Sector Vaccine Use and Cost ( by 13 years of Age) InjectionsCost 1980 - 7 Vaccines 7 $30 ( DTP, OPV, MMR ) 1996 - 10 Vaccines 16 $330 ( DTP, OPV, MMR, HIB, HBV, Varicella ) 2000 - 12 Vaccines 24 > $750 ( DT aP / dT , eIPV, MMR, HIB, HBV, Varicella Rotavirus, Pnu-conj ) 2005 - 14 Vaccines 25 > $900 ( DT aP / dTaP , eIPV, MMR, HIB, HBV, Varicella Influenza, MCV4, Pnu-conj )

  9. Expanding Vaccination Schedule Escalating Vaccine Costs Vaccine Shortages Immunization Advocacy Challenges Provider Skepticism/ Office Overload

  10. THE IMMUNIZATION PROGRAM FROM THE PRACTITIONER’S PERSPECTIVE VAERS LIABILITY CONSENT VIS IMMUNIZATION REGISTRY MANUFACTURERS MEDICAID FDA CDC / NIP H.E.D.I.S. VFC STATE DOH AAP ACIP RED BOOK AAFP TRACKING / RECALL CASA MULTIPLE SHOTS SCHEDULE CHANGES ADMINISTRATION FEE IMMUNIZATION RECOMMENDATION

  11. “Convincing physicians to pursue common immunization goals is like trying to herd cats”

  12. Expanding Vaccination Schedule Escalating Vaccine Costs Vaccine Shortages Immunization Advocacy Challenges Anti-Vaccine Criticism Provider Skepticism/ Office Overload

  13. Societal Trends Critical of Vaccine Use • Zero-risk, Blaming / Litigious society • Anti-vaccine movement • Holistic, Naturopathic Roots • Installing “pathogenic” material into Healthy Bodies. • Anti-Authority • Personal Freedoms supercede Community Welfare • Governmental attempt to gain control of Private Lives. • Abuse of the public trust • Capitalism and Conflicts of Interest for Vaccine Manufacturers and National Policy Makers • Information society (Internet websites) • Where is the Truth?

  14. Expanding Vaccination Schedule Escalating Vaccine Costs Vaccine Shortages Immunization Advocacy Challenges Anti-Vaccine Criticism Provider Skepticism/ Office Overload Vaccine Safety Concerns

  15. Most Important Sources of Immunization Information in Wisconsin TotalMDRN Chapter professional newsletters 14 12 2 State IP Official Updates 9 4 5 CME meetings 7 4 3 Clinic Resource 6 2 4 MMWR 2 0 2 ID seminars 2 0 2 Word of Mouth 2 1 1 Pharmaceutical reps 1 0 1 Medical Director 1 0 1

  16. Reedsburg Community Hospital Grand RoundsReedsburg, WisconsinFebruary 10, 2004 Demystifying the Mythology of Vaccine Safety Thomas N. Saari, M.D., F.A.A.P. University of Wisconsin-Madison School of Medicine, Department of Pediatrics Division of Pediatric Infectious Disease

  17. // // // Number of Cases n = 7 VAERS Reporting Results n = 52 RRV Vaccination Dose 1 Dose 2 n = 11 Dose 3 n = 4 Interval between RRV Vaccination and Intussusception (Days)

  18. Wisconsin Chapter AAP Survey Knowing RRV-TV’s safety profile*, would you give it? COID / ACIP Recommendation to give RRV Routinely to Infants < 6 m/o ? * IS about 1:10,000 first doses of RRV-TV Iwamoto M, Saari T et al. Peds 2003; 112: e6

  19. N. Halsey, S. Hyman ( USA ) No evidence MMR causes Autism / IRB Pediatrics, 2001;107 e84 Institute Of Medicine No Association between MMR and Autism May ,2004 Report B. Taylor et al. ( England ) No Correlation / Causation of MMR / Autism Lancet. 1999; 353: 2026 MMR and Autism Andrew Wakefield, MD MMR / IRB / Rogue Protein = Autism Theory “ Autistic Enterocolitis” Lancet 1998; 351:637 Lancet 1999; 354: 949 ( letter ) J. Kaye et al ( England ) No Correlation / Causation of MMR / Autism Brit. Med J. E –Abstract, 2001 ( Feb ) P.Peltola et al ( Finland ) No MMR Association with Autism / IRB Lancet. 1998 ( May ) 351:1327 C. Gillberg, H. Heijbel ( Sweden ) No Correlation / Causation of MMR/Autism Autism, 1998; 2:42 Fombonne ( England) No Correlation of MMR with Autism Lancet. 1998 ( March): 351:955 L Dales et al ( California ) No Association of MMR / Autism JAMA. 2001 ( Mar ); 285: 1183

  20. Measles: Past,Present ,Future 750,000 global deaths yearly 0 by 2010 17,500 deaths averted USA since 1963 <100 annual USA cases in 1999 thru 2003, all imported Ireland > 1600 cases / 2 deaths from MMR scare Netherlands > 3000 cases / 3 deaths Korea 88 cases ( 1999 ) > 3,500 cases ( 2000 )

  21. T. Verstraten et al ( USA ) Safety of Thimerosal containing vaccines Pediatrics, 2003;112: 1039 Institute Of Medicine No Association between Thimerosal and ASD May ,2004 Report J. Heron et al ( England ) No evidence thimerosal exposure and NDD Pediatrics 2004; 114: 577 Thimerosal in Vaccines and Autism Mark Geier, M.D /David Geier Thimerosal in Childhood Vaccines and Neurodevelopmental Disorders…. J. Am. Phys and Surg 2003;vol 8: N. Andrews et al ( England ) No evidence thimerosal causes NDD Peds, 2004; 114: 584 K. Madsen et al ( Denmark ) No Thimerosal Association with Autism / IRB Peds. 2003; 112: 604 P. Stehr-Green ( Sweden) No evidence for an Association between Thimerosal and Autism Am J Prev Med 2003; 25:101 S. Parker et al ( USA ) No link between Thimerosal and Autism Peds 2004; 114: 793 A. Hviid et al ( Denmark) No Correlation between thimerosal and Autism JAMA 2003; 290: 1763

  22. Wisconsin Hospital Policies for Routine Hepatitis B Birthdosing ( 1993-2003 ) Thimerosal Alert Thimerosal Free Vaccine ALL INFANTS7/ 1999* 8/ 1999^3/ 2000^ 7/ 2003@ Hospitals ( # Births ) Overall 81% 48% 54% Small ( <500 ) 55% 55% Medium ( 500-999 ) 76% 47% Large ( >1000) 82% 64% * Hurie MB, Saari TN et al. Pediatrics 1995; 96: 875-79 ^ Hurie MB, Saari TN, Davis JP. Pediatrics.2001;107: 755-8. @ Russell A, Saari TN, Davis JP. 2004 in press

  23. Key Messages About Immunization Safety Vaccination is one of the most important ways in which parents can keep their child safe ( car seats, bike helmets). Vaccines are safe and closely scrutinized ( VAERS, VSD, CISA ) to make them safer ( DTwP DTaP, OPV IPV, ceasation of rotavirus vaccine ). Disease risks are much, much greater than the risk of vaccination. A parent’s decision to withhold vaccination from their child is an active decision to subject the child to the dangers of disease.

  24. Key Messages About Immunization Safety Delaying vaccination is risky ( vaccine schedules are designed to maximize protection at the most vulnerable age) Diseases spread in homes and schools where vaccination is suboptimal ( exemptors endanger school and household contacts who cannot be vaccinated ). Most parents who are concerned about vaccine safety worry about one vaccine, not all. Take the time to address the specific concern Reputable resources to learn about vaccine safety are readily available

  25. Reputable Vaccine Information Resources National Network for Immunization Information www.immunizationinfo.org National Immunization Program www.cdc.gov/nip American Academy of Pediatrics www.aap.org Immunization Action Coalition www.immunize.org American Public Health Association www.apha.org Institute for Vaccine Safety ( Johns Hopkins Univ.) www.vaccinesafety.edu Infectious Diseases Society of America www.idsociety.org Vaccine Education Center www.vaccine.chop.edu

  26. The most Credible Advocate for Vaccine Safety is YOU !!

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