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

1
39th 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 School of Medicine, Department
of Pediatrics Division of Pediatric Infectious
Disease
2
Comparison of Maximum and Current
MorbidityVaccine Preventable Diseases ( VPD) in
the USA

• VPD Max Cases Deaths 2002
  Cases
• Diphtheria 206,939 13,170 1
  
• Pertussis 265,269 5099 9771
• Tetanus 1,733 693 25
  
• Measles 894,134 7575 44
• Mumps 152,209 270
• Rubella 57,686 (10,000 CRS) 18
  ( 1 CRS)
• Polio 21,269 1879 0
  
• H. influenza b 20,000 600
  34
• Varicella 3.9 x 106 120
  9 ( 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 USA
1 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
Recommended Childhood and Adolescent Immunization
ScheduleUnited States 2007-8
Range of recommended ages
Catch-up vaccination
Preadolescent assessment
Vaccine/ Age
4-6 yr
11-12 yr
13-18 yr
Birth
1mo
4mo
6 mo
12 mo
15mo
2mo
18mo
24mo
Hepatitis B
HepB1
HBsAg(-) mom
Hep B Series
HepB2
HepB3
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-V1
MMR-V2
MMR-V2
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)
Injections Cost 1980 - 7 Vaccines 7
30 ( DTP, OPV, MMR ) 1996 - 10 Vaccines
16 330 ( DTP, OPV, MMR, HIB, HBV,
Varicella ) 2000 - 12 Vaccines 24
gt 750 ( DT aP / dT , eIPV, MMR, HIB, HBV,
Varicella Rotavirus, Pnu-conj ) 2005 - 14
Vaccines 25 gt 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
PRACTITIONERS PERSPECTIVE
VAERS
LIABILITY
CONSENT
VIS
IMMUNIZATION REGISTRY
MEDICAID
MANUFACTURERS
FDA
CDC / NIP
VFC
H.E.D.I.S.
STATE DOH
AAP
ACIP
RED BOOK
AAFP
TRACKING / RECALL
CASA
MULTIPLE SHOTS
ADMINISTRATION FEE
SCHEDULE CHANGES
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
Provider Skepticism/ Office Overload
Anti-Vaccine Criticism
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
Provider Skepticism/ Office Overload
Anti-Vaccine Criticism
Vaccine Safety Concerns
15
Most Important Sources of Immunization
Information in Wisconsin
Total MD RN 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
(No Transcript)
17
(No Transcript)
18
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
19
n 7
VAERS Reporting Results
n 52

• Dose 1

RRV Vaccination
Dose 2
n 11
Dose 3
n 4
Interval between RRV Vaccination and
Intussusception (Days)
20
(No Transcript)
21
Wisconsin Chapter AAP Survey
Knowing RRV-TVs safety profile, would you give
it?
COID / ACIP Recommendation to give RRV Routinely
to Infants lt 6 m/o ?
IS about 110,000 first doses of RRV-TV
Iwamoto M, Saari T et al. Peds 2003 112 e6
22
MMR and Autism
B. Taylor et al. ( England ) No Correlation /
Causation of MMR / Autism Lancet. 1999 353 2026
N. Halsey, S. Hyman ( USA ) No evidence MMR
causes Autism / IRB Pediatrics, 2001107 e84
Institute Of Medicine No Association between MMR
and Autism May ,2004 Report
Andrew Wakefield, MD MMR / IRB / Rogue Protein
Autism Theory Autistic Enterocolitis Lancet
1998 351637 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 ) 3511327
C. Gillberg, H. Heijbel ( Sweden ) No
Correlation / Causation of MMR/Autism Autism,
1998 242
Fombonne ( England) No Correlation of MMR with
Autism Lancet. 1998 ( March) 351955
L Dales et al ( California ) No Association of
MMR / Autism JAMA. 2001 ( Mar ) 285 1183
23
Measles Past,Present ,Future

• 750,000 global deaths yearly
  0 by 2010
• 17,500 deaths averted USA since 1963
• lt100 annual USA cases in 1999 thru 2003, all
  imported
• Ireland gt 1600 cases / 2 deaths from MMR
  scare
• Netherlands gt 3000 cases / 3 deaths
• Korea 88 cases ( 1999 ) gt 3,500 cases
  ( 2000 )

24
Thimerosal in Vaccines and Autism
J. Heron et al ( England ) No evidence
thimerosal exposure and NDD Pediatrics 2004
114 577
T. Verstraten et al ( USA ) Safety of Thimerosal
containing vaccines Pediatrics, 2003112 1039
Institute Of Medicine No Association between
Thimerosal and ASD May ,2004 Report
Mark Geier, M.D /David Geier Thimerosal in
Childhood Vaccines and Neurodevelopmental
Disorders. J. Am. Phys and Surg 2003vol 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 25101
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
25
Wisconsin Hospital Policies for Routine Hepatitis
B Birthdosing ( 1993-2003 )
Thimerosal Alert
Thimerosal Free Vaccine

• ALL INFANTS 7/ 1999 8/ 1999 3/ 2000
  7/ 2003_at_
• Hospitals ( Births )
• Overall 81 48 54
• Small ( lt500 ) 55
  55
• Medium ( 500-999 ) 76 47
• Large ( gt1000) 82 64

Hurie MB, Saari TN et al. Pediatrics 1995
96 875-79 Hurie MB, Saari TN, Davis JP.
Pediatrics.2001107 755-8. _at_ Russell A, Saari
TN, Davis JP. 2004 in press
26
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 parents decision to
  withhold vaccination from their child is an
  active decision to subject the child to the
  dangers of disease.

27
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

28
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

29
The most Credible Advocate for Vaccine Safety
is YOU !!