Transcript Present

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
Comparison of Maximum and Current Morbidity:
Vaccine Preventable Diseases ( VPD) in the USA
VPD
Diphtheria
Pertussis
Tetanus
Measles
Mumps
Rubella
Polio
H. influenza b
Varicella
Hepatitis B
Max Cases
Deaths
2002 Cases
206,939
13,170
1
265,269
5099
9771
1,733
693
25
894,134
7575
44
152,209
270
57,686
(~10,000 CRS*)
18 ( 1 CRS*)
21,269
1879
0
20,000
600
34
3.9 x 106
120
9 ( Deaths )
300,000 est
5200
20,000 est
* Congenital Rubella Syndrome
Vaccines and the
provision of immunization services
are now scrutinized more intensely
than the diseases
they are designed to prevent
Expanding Vaccination
Schedule
Vaccine Shortages
Immunization
Advocacy Challenges
Recommended Childhood Immunization Schedule: USA
1980
AGE
Vaccine
2 Mo
4 Mo
6 Mo
Diphtheria , Tetanus Toxoid,
DTwP DTwP DTwP
Pertussis
Polio
Measles, Mumps, Rubella
OPV OPV
12 Mo 15 Mo 18Mo
4-6
yrs
DTwP
DTwP
OPV
OPV
MMR
14 -15
yrs
dT
Recommended Childhood and Adolescent Immunization Schedule:United States 2007-8
Range of recommended ages
Vaccine/ Age
Hepatitis B
Birth 1mo
Catch-up vaccination
2mo
4mo
6 mo
12 mo
Preadolescent assessment
15mo
18mo
24mo
HepB#1 HBsAg(-) mom
HepB#2
Diphtheria,
Tetanus, Pertussis
DTaP
DTaP
H. flu B
Hib
Hib
Hib
Inactivated Polio
eIPV eIPV
PCV13PCV13 PCV13
Influenza
DTaP
DTaP
eIPV
eIPV
MMR-V#1
MMR-V#2
dTaP
MMR-V#2
Influenza ( Yearly )
MCV4
MCV4
RVV5 RVV5 RVV5
Hepatitis A
Td
eIPV
PCV13
Influenza ( Yearly )
Meningococcal
Conjugate
Rotavirus ( PO )
13-18
yr
Hib
Measles Mumps
Rubella, Varicella
Pneumo Conj
11-12
yr
Hep B Series
HepB#3
DTaP
4-6
yr
Hepatitis A Series
Human Papilloma Virus
Vaccines below this line are for select populations
HPV
PCV7
PPV
Expanding Vaccination
Schedule
Vaccine Shortages
Escalating
Vaccine Costs
Immunization
Advocacy Challenges
Private Sector Vaccine Use and Cost
( by 13 years of Age)
1980 - 7 Vaccines
Injections
7
Cost
$30
( DTP, OPV, MMR )
1996 - 10 Vaccines
( DTP, OPV, MMR, HIB, HBV, Varicella )
16
$330
2000 - 12 Vaccines
24
> $750
25
> $900
( DT aP / dT , eIPV, MMR, HIB, HBV, Varicella
Rotavirus, Pnu-conj )
2005 - 14 Vaccines
( DT aP / dTaP , eIPV, MMR, HIB, HBV, Varicella
Influenza, MCV4, Pnu-conj )
Expanding Vaccination
Schedule
Vaccine Shortages
Escalating
Vaccine Costs
Immunization
Advocacy Challenges
Provider Skepticism/
Office Overload
THE IMMUNIZATION PROGRAM
FROM THE PRACTITIONER’S PERSPECTIVE
VAERS
LIABILITY
CONSENT
MANUFACTURERS
H.E.D.I.S.
FDA
VIS
MEDICAID
CDC / NIP
IMMUNIZATION
REGISTRY
VFC
STATE DOH
RED BOOK
AAP
ACIP
AAFP
MULTIPLE SHOTS
SCHEDULE CHANGES
CASA
TRACKING / RECALL
ADMINISTRATION FEE
IMMUNIZATION RECOMMENDATION
“Convincing physicians to pursue
common immunization goals is like
trying to herd cats”
Expanding Vaccination
Schedule
Vaccine Shortages
Escalating
Vaccine Costs
Immunization
Advocacy Challenges
Anti-Vaccine
Criticism
Provider Skepticism/
Office Overload
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?
Expanding Vaccination
Schedule
Vaccine Shortages
Escalating
Vaccine Costs
Immunization
Advocacy Challenges
Anti-Vaccine
Criticism
Provider Skepticism/
Office Overload
Vaccine Safety
Concerns
Most Important Sources of
Immunization Information in Wisconsin
Total MD
Chapter professional newsletters 14
12
State IP Official Updates
9
4
CME meetings
Clinic Resource
MMWR
ID seminars
Word of Mouth
Pharmaceutical reps
Medical Director
7
6
2
2
2
1
1
4
2
0
0
1
0
0
RN
2
5
3
4
2
2
1
1
1
Reedsburg Community Hospital Grand Rounds
Reedsburg, Wisconsin
February 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
20
n=7
VAERS
Reporting
Results
15
Dose 1
n = 52
RRV
10
Vaccination
5
0
//
Dose 2
5
n = 11
0
10
//
Dose 3
5
n=4
//
Interval between RRV Vaccination and Intussusception
(Days)
146
70
60
50
40
30
20
10
0
-10
-20
-30
-40
-50
-60
0
-70
Number of
Cases
10
Wisconsin Chapter AAP Survey
Knowing RRV-TV’s safety profile*, would you give it?
(n=133)
COID / ACIP
Recommendation to give
RRV Routinely to
Infants < 6 m/o ?
Yes
32%
No
68%
* IS about 1:10,000 first doses of RRV-TV
Iwamoto M, Saari T et al. Peds 2003; 112: e6
MMR and Autism
N. Halsey, S. Hyman ( USA )
Institute Of Medicine
No evidence MMR causes
No Association between
Autism / IRB
MMR and Autism
Pediatrics, 2001;107 e84
May ,2004 Report
J. Kaye et al ( England )
No Correlation /
Causation of MMR /
Autism
Brit. Med J. E –Abstract,
2001 ( Feb )
B. Taylor et al. ( England )
No Correlation / Causation of
MMR / Autism
Lancet. 1999; 353: 2026
Andrew Wakefield, MD
MMR / IRB / Rogue
Protein = Autism Theory
“ Autistic Enterocolitis”
P.Peltola et al ( Finland )
No MMR Association with
Autism / IRB
Lancet. 1998 ( May ) 351:1327
Lancet 1998; 351:637
Lancet 1999; 354: 949 ( letter )
C. Gillberg, H. Heijbel
Fombonne ( England)
No Correlation of MMR
with Autism
L Dales et al ( California )
No Association
( Sweden )
Lancet. 1998 ( March):
of MMR / Autism
No Correlation / Causation of
MMR/Autism
351:955
JAMA. 2001 ( Mar ); 285: 1183
Autism, 1998; 2:42
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 )
Thimerosal in Vaccines and Autism
T. Verstraten et al ( USA )
Institute Of Medicine
J. Heron et al ( England )
Safety of Thimerosal
containing vaccines
No Association between
Thimerosal and ASD
No evidence thimerosal
exposure and NDD
Pediatrics, 2003;112: 1039
May ,2004 Report
Pediatrics 2004; 114: 577
N. Andrews et al ( England )
Mark Geier, M.D /David Geier
K. Madsen et al ( Denmark )
No evidence thimerosal
causes NDD
Thimerosal in Childhood
Vaccines and Neurodevelopmental
Disorders….
No Thimerosal Association
with Autism / IRB
Peds, 2004; 114: 584
J. Am. Phys and Surg 2003;vol 8:
P. Stehr-Green ( Sweden)
A. Hviid et al ( Denmark)
Peds. 2003; 112: 604
S. Parker et al ( USA )
No Correlation between
thimerosal and Autism
No evidence for an Association
between Thimerosal and
Autism
No link between Thimerosal
and Autism
JAMA 2003; 290: 1763
Am J Prev Med 2003; 25:101
Peds 2004; 114: 793
Wisconsin Hospital Policies for Routine Hepatitis B Birthdosing
( 1993-2003 )
ALL INFANTS
7/ 1999*
Hospitals ( # Births )
Overall
81%
Small ( <500 )
55%
Medium ( 500-999 )
76%
Large ( >1000)
82%
Thimerosal
Alert
8/ 1999^
Thimerosal
Free Vaccine
3/ 2000 ^
48%
* 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
7/ 2003@
54%
55%
47%
64%
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.
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
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
The most Credible Advocate for
Vaccine Safety is YOU !!