Vaccine Safety Workshop

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1 Vaccine Safety Workshop Dean A. Blumberg, MD, FAAP Disclosure speakers bureau: sanofi pasteur Discussion off label use of FDA approved vaccines

2 Vaccine Safety: Outline DB MS DB vaccine-preventable diseases (VPD)» successes: herd immunity» risk of VPD resurgence personal belief exemption rates rising» risk of VPD to unvaccinated & community Vaccine recommendation process Vaccine safety monitoring programs San Diego personal belief exemption clustering and risk of VPD Common parental vaccine safety concerns

3 Vaccine-Preventable Diseases: Baseline 20th Century & Current Morbidity MMWR 1999;48:245, 2013;62(33)

4 Several slides relating to smallpox vaccine and eradication of smallpox

5 What is Herd Immunity?

6 Susceptible Population

7 Herd immunity: Partially Vaccinated Population x x x

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9 Several slides relating to polio vaccine and current resurgence

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12 Permanent Medical Exemptions & Personal Beliefs Exemptions, Kindergarten Students, California 3.5% Percent of Students 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% PME PBE 0.0% Year of Assessment Lee et al NVIC 2010

13 Several slides relating to VPDs and increased risk if not vaccinated

14 Kindergarten PBEs by County

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19 Mark Talks Here

20 Vaccine Adverse Event Myths No credible scientific evidence that vaccines cause: autism multiple sclerosis diabetes asthma inflammatory bowel disease SIDS overwhelm immune system

21 Several slides relating to Dr. Bob and Jenny M

22 Overwhelm Immune System? Infant immune system naïve can respond to thousands of antigens simultaneously Challenges other than vaccines natural environmental exposures» strep throat: >50 antigens» otitis media: >2,000 antigens

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24 Number of Immunogens in Vaccines Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Smallpox ~200 Smallpox ~200 Diphtheria 1 Diphtheria 1 Diphtheria 1 Tetanus 1 Tetanus 1 Tetanus 1 Pert-WC ~3000 Pert-AC 2-5 Pert-WC ~3000 Polio 15 Polio 15 Polio 15 Measles 10 Measles 10 Mumps 9 Mumps 9 Rubella 5 Rubella 5 Hib 2 Varicella 69 PCV 8 Hepatitis B Hepatitis A MCV RV HPV Influenza* Total ~200 Total ~3217 Total ~3041 Total Offit et al, Pediatrics 2002;109:124 *Influenza yearly, new strains every year

25 Number of Immunogens in Vaccines Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Smallpox ~200 Smallpox ~200 Diphtheria 1 Diphtheria 1 Diphtheria 1 Tetanus 1 Tetanus 1 Tetanus 1 Pert-WC ~3000 Pert-AC 2-5 Pert-WC ~3000 Polio 15 Polio 15 Polio 15 Measles 10 Measles 10 Mumps 9 Mumps 9 Rubella 5 Rubella 5 Hib 2 Varicella 69 PCV 8 Hepatitis B Hepatitis A MCV RV HPV Influenza* Total ~200 Total ~3217 Total ~3041 Total Offit et al, Pediatrics 2002;109:124 *Influenza yearly, new strains every year

26 Number of Immunogens in Vaccines Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Smallpox ~200 Smallpox ~200 Diphtheria 1 Diphtheria 1 Diphtheria 1 Tetanus 1 Tetanus 1 Tetanus 1 Pert-WC ~3000 Pert-AC 2-5 Pert-WC ~3000 Polio 15 Polio 15 Polio 15 Measles 10 Measles 10 Mumps 9 Mumps 9 Rubella 5 Rubella 5 Hib 2 Varicella 69 PCV 8 Hepatitis B Hepatitis A MCV RV HPV Influenza* Total ~200 Total ~3217 Total ~3041 Total Offit et al, Pediatrics 2002;109:124 *Influenza yearly, new strains every year

27 Number of Immunogens in Vaccines Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Vaccine Immunogens Smallpox ~200 Smallpox ~200 Diphtheria 1 Diphtheria 1 Diphtheria 1 Tetanus 1 Tetanus 1 Tetanus 1 Pert-WC ~3000 Pert-AC 2-5 Pert-WC ~3000 Polio 15 Polio 15 Polio 15 Measles 10 Measles 10 Mumps 9 Mumps 9 Rubella 5 Rubella 5 Hib 2 Varicella 69 PCV 14 Hepatitis B Hepatitis A MCV RV HPV Influenza* Total ~200 Total ~3217 Total ~3041 Total Offit et al, Pediatrics 2002;109:124 *Influenza yearly, new strains every year

28 Thimerosal Concerns: Neurotoxin? Thimerosal preservative ethylmercury Toxicity data methylmercury 7 well done studies methods» both retrospective & prospective» ecological & cohort» several 100,000 children results: no association

29 Thimerosal Content: US Vaccines Vaccine Trade name Manufacturer Thimerosal Concentration DTaP Tripedia Sanofi Pasteur % Infanrix GlaxoSmithKline 0 Daptacel Sanofi Pasteur 0 DTaP-HepB-IPV Pediarix GlaxoSmithKline 0 Tdap Adacel Sanofi Pasteur 0 Boostrix GlaxoSmithKline 0 ActHIB Sanofi Pasteur 0 PedvaxHIB Merck & Co, Inc 0 Haemophilus influenzae type b conjugate (Hib) Hib/Hepatitis B combo Comvax Merck & Co, Inc 0 Hepatitis B Engerix B GlaxoSmithKline 0 Recombivax HB Merck & Co, Inc 0 Hepatitis A/Hepatitis B Twinrix GlaxoSmithKline <0.0002% Influenza* Various Various Varies

30 Aluminum Concerns Aluminum in vaccines adjuvant maximum amount 0.85 mg/dose Aluminum exposure deodorant food» adults average 7-9 mg/day 200 mg in antacids breast milk» 0.04 mg/l formula» mg/l

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33 MMR & Autism 1998: Wakefield Lancet publication case series» 12 children Biological plausibility: no 10 well done studies methods» both retrospective & prospective» ecological & case control» millions of children results: no association

34 Several slides relating to lancet retraction and rep Bachman

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36 Why Parents Who Planned To Delay/Refuse Vaccine Changed Their Minds Gust et al Pediatr 2009;122:718

37 Parental Immunization Refusal Listen carefully to concerns encourage questions Discuss known risks and benefits risks to unimmunized child Concerns about specific vaccines discuss administer other vaccines Multiple injection concerns modify schedule Revisit discussion in future visits Document

38 Vaccine Safety Discussion Strategies Empathize: acknowledge that there are many conflicting messages in the media Assess level of scientific evidence desired Maximize benefits to their child not a public health discussion vaccines provide protection risk of disease for omitted vaccines Provide appropriate resources

39 Continued Vaccine Refusal Challenges time commitment for discussions» frustration Fire patient from practice/clinic? acknowledge differences» it sounds like you and I have different philosophies agree to disagree on this subject

40 Vaccine Safety Concerns: Resources CDC AAP NNII CHOP

41 MMWR 1999;48:241

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43 Vaccine Safety Communication: Summary Immunization challenges Know the concerns know the facts Discussion patience

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