infant and adolescent hepatitis b vaccination and use of combination vaccines united states
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Infant and Adolescent Hepatitis B Vaccination
and Use of Combination Vaccines
United States
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• Prevent perinatal HBV transmission (1984 - selective; 1988 – universal)
• Routine infant vaccination (1991)
• Catch-up vaccination
•11-12 year-old children (1995)
•All children <19 years of age (1997)
•Adults in high risk groups (1982)
Elimination of Hepatitis B Virus Transmission United States
Elimination of Hepatitis B Virus Transmission United States
Strategy
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Key Elements of Perinatal Hepatitis B Prevention Program, United States
• Testing all pregnant women for HBsAg
• Reporting of HBsAg-seropositive women
• Case-management and tracking to assure:
– HBIG and hepatitis B vaccine at birth
– completion of vaccine series by age 6 months
– post-vaccination serologic testing
– identification and vaccination of susceptible HH/sex contacts
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Evaluations of HBsAg ScreeningEvaluations of HBsAg Screening
of Pregnant Women, 1991-2001of Pregnant Women, 1991-2001
Study YearBirths
Reviewed, No.
MothersScreened, (%)
New York 1991 607 (96)Kansas 1992 412 (84)National 1993 3,982 (84)Washington 1994 4,031 (96)Ohio 1994 394 (96)Illinois 1994-5 1,361 (91)California 1995 5,414 (96)Florida 1995 365 (88)North Carolina 1997-98 4726 (92)Delaware 1999 N/A (91)8 states (EID sites) 2001 5135 (96.5)
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Identified and Expected Births to HBsAg-Positive Mothers United States, 1993-1999
0
20
40
60
80
100
1993 1994 1995 1996 1997 1998 1999
Year
Perc
ent
Iden
tifi
ed
0
5000
10000
15000
20000
Expe
cted
Num
ber
7874 8403 8002 8687 8841 8730 9503
19042 19250 19252 19617 19919 20254 20861
Expected
Identified
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HBsAg Seroprevalence among Pregnant Women HBsAg Seroprevalence among Pregnant Women by Prenatal Screening Status, Philadelphia, 1991by Prenatal Screening Status, Philadelphia, 1991
Prenatal Screening
No. of WomenTested No. (%)
HBsAg-positive
Yes 1555 12 (0.8)
No 208 14 (6.7)
Source: JAMA 1991;266:2852-5
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• Prevent perinatal HBV transmission (1984 - selective; 1988 – universal)
• Routine infant vaccination (1991)Routine infant vaccination (1991)• Catch-up vaccination
•11-12 year-old children (1995)
•All children <19 years of age (1997)
•Adults in high risk groups (1982)
Elimination of Hepatitis B Virus Transmission United States
Elimination of Hepatitis B Virus Transmission United States
Strategy
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HepB3, DTP3, and Hib3 Coverage, Among 19-35 Month-Old Children, 1992-2000
0102030405060708090
100
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
Year
Cov
erag
e, %
Routine HepB vaccination
recommended
HepB3
Hib3
DTP3
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Reported Cases of Acute Hepatitis B in ChildrenUnited States, 1985-2000
0
50
100
150
200
1985 1987 1989 1991 1993 1995 1997 1999Year
Rep
orte
d C
ases
Routine HepB vaccination
recommended1-4 years
5-9 years
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Estimated Non-Perinatal HBV Infections Estimated Non-Perinatal HBV Infections Among Children <10 Years of Age Among Children <10 Years of Age
United States, 1991United States, 1991
Racial/ Ethnic Group
Population (millions)
I ncidence
Per 100,000 (95% CI )
Annual
I nf ections, No. (95% CI )
Non-Asian 36.6 24 (9-62)
8,680 (3,310-22,770)
Asian 1.2 605 (471-783)
7,280 (5,670-9,420)
Total 37.8 42 (24-85)
15,950 (8,980-32,190)
Source: Armstrong, et al. Pediatrics 2001; in press
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Age of Acquisition for Persons with Age of Acquisition for Persons with Chronic HBV Infection, United StatesChronic HBV Infection, United StatesAge of Acquisition for Persons with Age of Acquisition for Persons with Chronic HBV Infection, United StatesChronic HBV Infection, United States
Newborn, 18%Newborn, 18%
Children, 18%Children, 18%
Adolescent, 6%Adolescent, 6%
Adult, 59%Adult, 59%
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• Prevent perinatal HBV transmission (1984 - selective; 1988 – universal)
• Routine infant vaccination (1991)
• Catch-up vaccinationCatch-up vaccination
•11-12 year-old children (1995)11-12 year-old children (1995)•All children <19 years of age All children <19 years of age (1997)(1997)
•Adults in high risk groups (1982)
Elimination of Hepatitis B Virus Transmission United States
Elimination of Hepatitis B Virus Transmission United States
Strategy
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National vaccination coverage levels of adolescents 13-15 years of age, NHIS
48
89
45
93
60
91
45
92
0102030405060708090
100
3+ Hep B 2+ MMR 1+ Varicella 1+ Td
Per
cen
t C
ove
rag
e
1997
1998
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ALASKA
CALIFORNIA
IDAHO
OREGON
WASHINGTON
MONTANA
WYOMING
UTAH
COLORADO
ARIZONANEW
MEXICO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH
DAKOTA
NORTH
DAKOTAMINNESOTA
WISCONSIN
IOWA
ILLINOIS
OHIOIN
KENTUCKY
WV
VIRGINIA
GEORGIA
FL
ALABAMA
MS
MISSOURI
ARKANSAS
LA
NEVADA
HAWAII
MICHIGAN
PENNSYLVANIA
NJ
NEW
YORK CT
MA
VT
NH
MAINE
TENNESSEE
CAROLINA
SO.
MD
DE
RI
States Requiring Hepatitis B Vaccination
Before Middle School Entry, 2001
NO.
CAROLINA
DC
31 of 50 States have HepB immunization requirements
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Reported cases of acute hepatitis B among 15-18 year oldsUnited States, 1990-2000
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Hepatitis B vaccine doses distributed in public sector United States, 1990-2000
0
5
10
15
20
Mill
ion
s of
dose
s Total
Monovalent HepB
Hib-HepB
0.4%8.5% 14.6% 18.3%
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Thimerosal: Changes in Hepatitis B Vaccine Recommendations, July 1999
Joint PHS-AAP Statement“Clinicians and parents can take
advantage of the flexibility within the existing schedule…to postpone the first dose of hepatitis B vaccine from birth until 2 to 6 months of age…”
AAP“If thimerosol-free vaccine is not
available, hepatitis B virus vaccination should be initiated at 6 months of age”
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HepB Doses Administered Before Age 2 MonthsOregon Immunization Registry, 2/99 – 3/00
0
200
400
600
800
1000
1200
02 06 10 14 18 22 26 30 34 38 42 46 50 02 06 10
Source: Oregon Immunization ALERT registry
Doses A
dm
inis
tere
d
Hep B given 0-56 days after birth
Hep B given0-5 days after birth
Joint Statement
Preservative-freeHepB available
in hospitals
Preservative-free HepB available through VFC
1999 2000Week
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Vaccine coverage among infants born to unscreened women, Oregon, 1999-2000
0
20
40
60
80
100
Apr-J un
1999
Aug-Oct
1999
Apr-J un
2000
HepB received<12 hours afterbirth
HepB receivedbefore discharge
July 11, 1999: CDC/AAP announcement to defer vaccination of infants born to HBsAg neg women No change in recs for unscreened women
August 28, 1999: Resume previous policies
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Why Should Birth Dose Be Given to All Infants?
• “Safety net” – If all get birth dose, eliminates missed immunoprophylaxis for infants born to HBsAg-positive mothers (a medical error)
• Assures immunoprophylaxis for infants born to unscreened women (10x more likely to be HBsAg-positive)
• May reduce number of doses that need to be given simultaneously with other vaccines
• May increase likelihood that the Hep B series will be given on schedule
• Conveys the importance of vaccination to parents
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Hepatitis B Combination VaccinesConcerns
• Requires use of 4 dose schedule to prevent perinatal HBV transmission – Potential to decrease use of birth dose – Increased cost/cost-effectiveness data? – Safety data?
• Need to assure adequate immunogenicity of all vaccine components in schedules used in developed and developing countries (w/ and w/o birth dose)
• Increased vaccine cost per dose– requires increased attention to vaccine wastage– smaller vaccine vials – increased need for cold chain
capacity• Could displace local DTP production
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