Transcript Surveillance For Hepatitis B

Thimerosal –Related Changes in
Vaccination Recommendations and
Hepatitis B Vaccine
Coverage Among United States Children
Harold S. Margolis, MD
Anthony Fiore, MD, MPH
Division of Viral Hepatitis
Centers for Disease Control and Prevention
Thimerosal and Vaccines
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Vaccine preservative that contains mercury
Until 1999, used in hepatitis B vaccine, some DTaP,
Hib and influenza vaccines
1999 FDA review: For some infants, mercury
exposure from vaccines exceeds FDA, but not EPA,
ATDSDR, or WHO guidelines
Concerns discussed among CDC, FDA and AAP
representatives late June 1999
No health effects from mercury in vaccines
identified
Quick fix: Hepatitis B vaccine could be “deferred”
for infants born to HBsAg negative women until 2
months old
Changes in Infant Vaccination
Recommendations Related to Thimerosal
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July 1999: Joint Statement on Thimerosal in Vaccines
(AAP/USPHS)
 Defer vaccination of infants born to HBsAg negative women
until 2-6 months old
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September 1999 : Thimerosal-free hepatitis B vaccine
distribution begins
 Resume previous vaccination practices
 Vaccinate newborns at birth or by age 2 months
December 2000: Sufficient supply of preservative-free
hepatitis B vaccines for all U.S. newborns
National Immunization Survey
• Standard for assessing national vaccine
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coverage since 1994
34,000 households per year complete telephone
interview
Target group: 19-35 month old children
Provider verification of vaccination
Largest ongoing telephone survey in the United
States
Percentage Received
3 Doses
Hepatitis B Vaccine 3 Dose Coverage Among
19-35 Month Old Children, by Year of Survey,
1990-2001*
100
82
80
84
87
88
90
89
68
60
37
40
20
8
16
0
1992 1993 1994 1995 1996 1997 1998 1999 2000 2001
Year
*Source: National Immunization Survey
Percentage of Children Who Received
Hepatitis B Vaccine at Birth, by State, 1998
VT
Overall: 55%
Range: 26% - 82%
>70%
SO.
50-69%
<50%
Source: National Immunization Survey, 19-35 month olds
Percentage of Children Who Received
Hepatitis B Vaccine at Birth, by State, 2001
VT
Overall: 45%
Range: 16% - 73%
>70%
SO.
50-69%
<50%
Source: National Immunization Survey, 19-35 month olds
Preliminary data
Defining the Effects of Thimerosal- Related
Changes in Immunization Recommendations
National Immunization Survey, 2001
• Determine hepatitis B vaccine coverage (3
dose and birth dose) coverage among
children born before, during and after
recommendations changes
• Compare changes in coverage for hepatitis
B vaccine with other infant vaccines
Methods
• Children born February 1998-May 2000
• Divided into 3 groups:
- Group 1: born Feb 1998 - Jun 1999
- Group 2: born Jul 1999 - Dec 1999
- Group 3: born Jan 2000 - May 2000
• Only vaccinations given before 19 months
counted to adjust for differences in age
Hepatitis B Vaccine Birth Dose Coverage (<7 days after
birth), 19 month old children, United States
Percentage received birth dose
Preliminary data, 2001 National Immunization Survey
100
90
80
70
60
50
40
30
20
10
0
Joint Statement
59.4
†
25
†
15.3
Feb98-Jun99
† Significantly
Thimerosal-free vaccine
Jul99-Dec99
Birth time period
Jan00-May00
lower (p<0.05) compared to children born before 7/1/99
Hepatitis B vaccine birth dose coverage ( < 1 day after
birth) among 19 month old children, United States
Percent received birth dose
Preliminary data, 2001 National Immunization Survey
100
90
80
70
60
50
40
30
20
10
0
Joint Statement
44.8
†
†
12
Feb98-Jun99
Birth
† Significantly
Thimerosal-free vaccine
timeJul99-Dec99
period
lower (p<0.05) compared to children born before 7/1/99
19
Jan00-May00
Hepatitis B Vaccine Coverage (>3 doses) Among
19 Month Old Children, United States
Preliminary data, 2001 National Immunization Survey
Percentage received 3
or more doses
Joint Statement
100
90
80
70
60
50
40
30
20
10
0
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87.6
79.7
Feb98-Jun99
† Significantly
Thimerosal-free vaccine
Jul99-Dec99
Birth
time period
lower (p<0.05) compared to children born before
83.6
Jan00-May00
Inadequate Vaccination (2 doses) Among 19
Month Old Children, United States, 2001
National Immunization Survey
Received 0 doses
Received 1 or 2 doses
Thimerosal-free vaccine
24
Percent
20
16
Joint Statement
21.3%†
16.4%†
12.4%
12
8
4
0
†
Feb98-Jun99
Jul99-Dec99
†
Jan00-May00
Birth time period
† Significantly
different (p<0.05) compared to children born before 7/1/99
Vaccination Coverage for Other
Infant Vaccines, 2001 NIS
• Coverage for DTaP, IPV, Hib, MMR, varicella
and 4:3:1:3 increased or stayed the same
compared to 2000*
• No difference in coverage among 2001 time
periods for DTP, IPV, Hib, MMR, 4:3:1:3
– Significant increase for varicella coverage
*Source: MMWR 2002
Conclusions
For infants participating in the 2001 NIS
(born February 1998 – May 2000):
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Hepatitis B birth dose and 3 dose coverage
decreased significantly after thimerosal-related
recommendations
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Hepatitis B vaccine birth dose and 3 dose vaccine
coverage remained lower than baseline even after
preservative-free vaccine was made available
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Vaccine coverage for other infant vaccines was not
reduced after thimerosal recommendations
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Reductions in birth dose coverage may have led to
reductions in 3 dose coverage at 19 months
Limitations
• NIS 2001 dataset not yet complete (expected
February 2003)
• Need to determine if children who did not receive
birth dose were same children who did not who
did not complete series
• HBsAg status of mothers not available from NIS
data
• Vaccine coverage for children born after both
preservative-free vaccines licensed not yet
available (2002 NIS)
HepB Doses Administered Before Age 2 Months
Oregon Immunization Registry, 2/99 – 3/00
Doses Administered
1200
Joint Statement
1000
800
600
400
200
Hep B given
0-56 days after birth
Preservative-free
HepB available
through VFC
Preservative-free
HepB available
in hospitals
Hep B given
0-5 days after birth
0
1999
Week
Source: Oregon Immunization ALERT registry
2000
Effects on Prevention of Perinatal HBV
Infection
Prevention of Perinatal and Early
Childhood HBV Infection
Ensure hospital standing orders that require:
• Documented HBsAg status or testing for mothers of all
newborns before discharge
• Routine postexposure prophylaxis for infants of HBsAgpositive mothers
• Newborn vaccination of infants born to mothers without
prenatal HBsAg testing
• Newborn vaccination of infants at high risk of early
childhood HBV infection
Effect of Thimerosal Recommendations on Hospital
Policies for Newborn Hepatitis B Vaccination
Maternal HBsAg
status
Before
Jan-June ‘99
Statement
Jul-Oct ‘99
Nov-Dec ‘99
Positive
98%
86%
91%
Unknown
87%
60%
67%
Negative
85%
17%
34%
National Survey of Hospitals (n=773)
After
Fulminant Hepatitis B, Michigan, 1999
• Mother: 15 year old primagravida, Hmong teenager
• Prenatal care: 10 visits, HBsAg (+) -- not reported to
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health department
July 1999 - hospital discontinued routine newborn
hepatitis B vaccination
September 2, 1999 = term birth. Infant received no
hepatitis B vaccine. Prenatal record = “hepatitis
negative”.
November 29,1999 = first dose hepatitis B vaccine
Fulminant Hepatitis B, Michigan, 1999
• December 14, 1999: infant admitted to hospital with
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jaundice, diarrhea. Dx = HBV acute liver failure
December 17, 1999: infant died awaiting liver
transplantation
Further work-up showed infant was HBeAg-negative with
precore stop codon
Fall 2000 – mother dies from ectopic pregnancy
Proportion of MICHIGAN infants born to women
of unknown status vaccinated, 1999-2000
60
50
40
Vaccinated before
D/C
Vaccinated w/in 12
hours
30
20
P<0.001
10
0
Mar-Apr 99
Jul15-Sep15
99
Mar-Apr 00
Effect of Thimerosal Recommendations on
Birth Dose for Infants of Mothers with
Unknown HBsAg Status, Oregon
• Identified infants born to mothers with unknown
HBsAg status – used electronic birth certificate data
– 3 time periods: before, after, thimerosal free
• Reviewed charts = 64% of hospitals & 40% of births
• Identified 308 mothers (1.9% of births)
– 298 with adequate data
– 147 (49%) remained unknown HBsAg at discharge
Hospitals Policy to Hepatitis B Vaccine to All
Newborns Before Discharge (n=53)
100
89
80
70
74
60
40
20
4
0
Prior to July
1999
Immediately
after AAP
statement
Apr-00
May-01
Proportion of OREGON infants born to women
of unknown status vaccinated, 1999-2000
90
80
70
60
50
40
30
20
Vaccinated before
D/C
Vaccinated w/in 12
hours
P<0.001
10
0
Apr-Jun 99
Aug-Oct 99
Apr-Jun 00
States Report Hundreds of Medical Errors in
Perinatal Hepatitis B Prevention
Avoid tragic mistakes—vaccinate newborns against HBV in the
hospital
By Teresa A. Anderson, DDS, MPH, and Deborah L. Wexler, MD*
Other Effects on Immunization
Your resource for Thimerosal claims
Get a free case assesment!
Parker and Waichman has filed a Class
Action Lawsuit against manufacturers of
vaccines containing Thimerosal. Visit
www.vaccineclassaction.com for more
information.
It is estimated that 17 percent of US children under the age of 18 are suffering
from learning and/or behavioral disabilities. California's Department of
Developmental Services reported a 20 percent increase over the previous year
for diagnoses of level-one autism. Level-one autism is the number one
disability in the state of California, accounting for 35 percent of all new cases.
Of the 16,802 persons with level-one autism in the California system, twothirds of them are between the ages of birth and 13.
To see if you have an Thimerosal related case, click here
AAP News Vol. 22 No. 1 January 2003, p. 4
WASHINGTON REPORT
Thimerosal cases in Oregon dismissed
Marjorie Tharp
Washington Correspondent
An Oregon judge has dismissed most of the class action lawsuits filed in
that state alleging injury from thimerosal in vaccines, including the case
that named not only manufacturers, but also a pediatrician.
This is the second time a judge has tossed out a case. Earlier this
summer, a federal court in Texas dismissed another thimerosal-related
class action lawsuit but said the plaintiffs could still sue for loss of
consortium or companionship. At press time, however, more than a
dozen states had individual or class action lawsuits pending.
The suits have been filed by or on behalf of families who believe their
children were injured by vaccines containing thimerosal, a mercurycontaining preservative. Although no evidence of harm existed, the
Academy and the federal government called for manufacturers to
remove thimerosal as a precautionary measure in 1999.
Institute of Medicine Immunization Safety Review
Thimerosal-Containing Vaccines and
Neurodevelopmental Disorders
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Biologic Plausibility
“….although the hypothesis that exposure to thimerosol-containing
vaccines could be associated with neurodevelopmental disorders is not
established and rests on indirect and incomplete information, primarily
from analogies with methylmercury and levels of maximum mercury
exposure given children in vaccines, the hypothesis is biologically
plausible.”
Causality
“….the evidence is inadequate to accept or reject a causal relationship
between exposure to thimerosal from vaccines and the
neurodevelopmental disorders of autism, ADHD, and speech or
language delay.”
Significance Assessment
National Academy Press, 2001
Institute of Medicine Immunization Safety Review
Thimerosal-Containing Vaccines and
Neurodevelopmental Disorders
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Significance Assessment
– First.
The diseases prevented by the vaccines under discussion are
serious and important
– Second. Understanding the risks of thimerosal is important because of
the need for its continued use.
– Third. Many countries still depend on the use of thimerosal in multidose vaccine supply
– Fourth. Lessons can be learned from the decision making process
surrounding policy changes for hepatitis B immunization
– Finally. Concerns about adverse events from thimerosal have the
potential to erode trust in immunization
National Academy Press, 2001
Comments
• Rapid changes in vaccination recommendations must be
accompanied by effective communication messages
• Changes in immunization policy should be evidence
based – the risks of childhood HBV infection were ignored
by decision makers
• Communication about immunization policy changes must
come from organizations that are seen by practitioners
that immunize children as their soure of information
– The AAP/PHS Joint statement differed from the AAP
statement with respect to hepatitis B vaccination
Acknowedgements
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Ann Thomas
Beth Bell
Eric Mast
Beth Luman
Tara Strine
Hussain Yusuf
Lawrence Barker
Nancy Fasano
Thomas Saari