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October 11, 2005 Walter A. Orenstein, M.D. Professor of Medicine and Pediatrics Director, Emory Vaccine Policy and Development

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Vaccine Safety Controversies AAP – General Session. October 11, 2005 Walter A. Orenstein, M.D. Professor of Medicine and Pediatrics Director, Emory Vaccine Policy and Development Associate Director, Emory Vaccine Center.

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slide1

Vaccine Safety Controversies

AAP – General Session

October 11, 2005

Walter A. Orenstein, M.D.

Professor of Medicine and Pediatrics

Director, Emory Vaccine Policy and Development

Associate Director, Emory Vaccine Center

slide3
Physician Reports of Parental Vaccine Safety Concerns in 2000- Results of a National Survey of Pediatricians+

+ Freed GL et al. Am J Prev Med 2004;26:11-14

++ Response from pediatricians and family physicians combined

major vaccine safety concerns
Major Vaccine Safety Concerns

Autism and thimerosal

Autism and MMR

Multiple immunizations and

Diabetes

Asthma

Heterologous infections

MCV4 and GBS

california estimated prevalence of autism and estimated mercury exposure in vaccines
California Estimated Prevalence of Autism and Estimated Mercury Exposure in Vaccines

From Stehr-Green P et al. Am J Prev Med 2003; 25:101-106

thimerosal and autism characteristic findings in autism and in mercury poisoning
Thimerosal and AutismCharacteristic findings in Autism and in Mercury Poisoning†

† Nelson KB, Bauman ML. Pediatrics 2003; 111: 674-679

all mercury is not the same
All Mercury is Not the Same
  • Major toxicity – methyl Hg
  • Ethyl mercury – shorter ½ life
    • Less associated with neurotoxicity
slide8
Blood Mercury Concentrations in Infants Aged 2 Months (diamonds) and 6 Months (squares) by Time of Sampling

All values <29 nMOL/L safety limit

Lancet 2002; 360: 1737-1741

incidence rate of autism in sweden cumulative thimerosal in vaccines
Incidence Rate of Autism in Sweden & Cumulative Thimerosal in Vaccines

From Stehr-Green P et al. Am J Prev Med 2003; 25:101-106

methodologic evaluation of studies addressing link of autism and thimerosal
Methodologic Evaluation of Studies Addressing Link of Autism and Thimerosal†

† Parker SK et al. Pediatrics 2004; 114:793-804

institute of medicine immunization safety review vaccines and autism
Institute of MedicineImmunization Safety Review Vaccines and Autism†
  • The Committee concludes that the evidence favors rejection of a causal relationship between 1) thimerosal-containing vaccines and autism and 2) MMR vaccine and autism.

† Immunization Safety Review Committee, Institute of Medicine,

National Academies Press, 2004

institute of medicine immunization safety review vaccines and autism1
Institute of MedicineImmunization Safety Review Vaccines and Autism†
  • In the absence of experimental or human evidence that vaccination (either the MMR vaccine or the preservative thimerosal) affects metabolic, developmental, immune, or other physiological or molecular mechanisms that are causally related to the development of autism, the Committee concludes that the hypotheses generated to date are theoretical only.

† Immunization Safety Review Committee, Institute of Medicine,

National Academies Press, 2004

maximum content of mercury in vaccines children receive through 6 months of age
Maximum Content of Mercury in Vaccines Children Receive Through 6 months of Age

† Ball LK et al. Pediatrics 2001; 107:1147-1154

†† www.fda.gov/cber/vaccine/thimerosal.htm, accessed 7/6/05

children receiving autism services by quarter california 2002 2005
Children Receiving Autism Services by Quarter, California, 2002-2005

California Department of Developmental Services

From Steve Cochi, MD, acting director, NIP/CDC provided for the National Immunization Awareness Month press

briefing held at the National Press Club on July 26, 2005

linking autism and mmr i
Linking Autism and MMR* — I
  • Report of 12 cases of autism and bowel disease, 8 after MMR
  • Ileal-lymphonodular hyperplasia
  • Speculated measles-caused bowel disease
  • Leak of toxins

*Lancet 1998;351:637-41

linking autism and mmr ii
Linking Autism and MMR* — II
  • Other information used to support link of autism and MMR
    • Detection of measles virus in bowel (Molecular Pathology 2002; 55: 84-90)
    • Detection of measles virus in lymphocytes*
    • Statistical correlation of natural measles† and mumps infections in same year

*Digestive Diseases and Sciences 2000;45:723-729

†Gastroenterology 1999;118:796-803

studies against mmr and autism link
Studies Against MMR and Autism Link
  • Ecologic – no clustering of onset or diagnosis around vaccination†
    • Regressive evaluated separately
    • No relationship to inflammatory bowel disease‡
    • Studies failing to detect measles virus in bowel (in IBD cases)

†BMJ 2002; 324: 393-6

‡Archives Pediatr Adolesc Med 2001; 155: 354-9

danish mmr autism study
Danish MMR/Autism Study

Results – Adjusted RR (95% CI)*

Aut DisOther Spect Dis

Overall 0.92 (.68-1.24) 0.83 (.63-1.07)

Age at vac 0.56-1.20 0.62-1.09

Time from vac 0.39-1.38 0.31-1.18

Yr of vac 0.73-1.35 0.71-1.13

* age, sex, calendar period, bw, gest age, mat educ, family SES

N Engl J Med 2002; 347: 1477-82

slide19
Percentage of Children Receiving MMR in Second Year of Life and Caseload of Children With Autism, by Year of Birth,California, 1980-1994*

*JAMA 2001, 285: 1183 - 1185

number of immunogenic proteins and polysaccharides in vaccines since 1960
Number of Immunogenic Proteins and Polysaccharides in Vaccines Since 1960†

TOTAL

†From Pediatrics 2002; 109: 124-129

theoretical calculation of number of antigens an infant can respond to at one time
Theoretical Calculation of Number of Antigens an Infant can Respond to at One Time†
  • 10,000 vaccines
    • Assuming 107 B cells/ul
    • And 103 epitopes per vaccine

†From Pediatrics 2002; 109: 124-129

iom conclusions on multiple antigens
IOM Conclusions on Multiple Antigens†
  • Evidence favored rejection of a causal relationship between multiple immunizations and increased risk for infections and type 1 diabetes
  • Evidence insufficient to accept or reject a causal relationship for allergic disorders including asthma
  • Did not recommend a policy review of current recommendations

† Institute of Medicine – Immunization Safety Review: multiple immunizations and immune dysfunction. 2/20/02

slide23
Relative Risk of Developing Asthma by Immunizations Received and Correcting for Medical Care Utilization†

†Pediatr Infect Dis J 2002; 21: 498-509

Also see Pediatrics 2003; 111: 653-659

2 HMOs

meningococcal conjugate vaccine and guillain barr syndrome gbs i
Meningococcal Conjugate Vaccine and Guillain Barré Syndrome (GBS) - I†
  • Incidence of meningococcal disease ~1/100,000
  • 5 cases of GBS in 17-18 year olds within 2-5 weeks post vaccination reported to VAERS
  • 2.5 million doses distributed to date
  • According to CDC, rate similar to what might be expected by coincidence, within 6 weeks of vaccination. However, timing of concern.

†Source: MMWR Dispatch Vol. 54, October 6, 2005. Available at www.cdc.gov

meningococcal conjugate vaccine and guillain barr syndrome gbs ii
Meningococcal Conjugate Vaccine and Guillain Barré Syndrome (GBS) - II†
  • No cases of GBS in 110,000 MCV4 recipients in VSD
  • According to CDC, no changes in vaccine recommendations at present
  • Please report any cases of GBS or other neurologic illnesses that follow MCV4 to VAERS
  • Please inform adolescents and caregivers of ongoing investigation into this issue.

†Source: MMWR Dispatch Vol. 54, October 6, 2005. Available at www.cdc.gov

conclusions
Conclusions
  • The best available evidence does not support a role for thimerosal or MMR in causing autism
  • The infant immune system should be able to respond to many vaccines simultaneously
  • Epidemiologic studies have not found a relationship between multiple immunizations and other infections, type 1 diabetes, and asthma
  • Ongoing studies to evaluate MCV4 and GBS
danish immunization and diabetes study
Danish Immunization and Diabetes Study†

† N Engl J Med 2004; 350: 1398-04

biological mechanisms supporting a role for vaccines in causing heterologous infections
Biological Mechanisms Supporting a Role for Vaccines in Causing Heterologous Infections+

Immune interference

T-cell cross reactivity

Carrier induced epitope suppression

Competition for antigen presentation (peptide competition for binding to MHC molecules or competition between T cells for the same antigen presenting cells)

+ Stratton K, Wilson CB, McCormick MC, editors. Immunization Safety Review.

Multiple Immunizations and Immune Dysfunction. Institute of Medicine

www.iom.edu/imsafety

study of heterologous infectious disease hospitalizations and vaccines denmark
Study of Heterologous Infectious Disease Hospitalizations and Vaccines, Denmark+
  • 2,900,464 person years of follow-up; 83,317 cases identified
  • 42 possible associations (6 vaccines and 7 infectious disease categories)
  • Only 1 positive association – Hib and URI RR 1.05 95% CI (1.01-1.08)
  • Within positive associations expected by chance

+ Hviid A et al. JAMA 2005; 294:699-705

useful websites with information on vaccine safety i
Useful Websites with Information on Vaccine Safety I

National Immunization Program

www.cdc.gov/nip

American Academy of Pediatrics

www.aap.org

Immunization Action Coalition

www.immunize.org

Children’s Hospital of Philadelphia Vaccine Education Center

www.chop.edu/vaccine

useful websites with information on vaccine safety ii
Useful Websites with Information on Vaccine Safety II

Institute of Medicine

www.IOM.edu/imsafety

National Partnership for Immunization

www.partnersforimmunization.org

National Network for Immunization Information

www.immunizationinfo.org

Institute for Vaccine Safety

www.vaccinesafety.edu

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