Infant and Adolescent Hepatitis B Vaccination

and Use of Combination Vaccines

United States

• 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

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

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)

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

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

• 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

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

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

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

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%

• 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

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

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

Reported cases of acute hepatitis B among 15-18 year oldsUnited States, 1990-2000

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%

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”

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

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

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

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