Infant and Adolescent Hepatitis B Vaccination and Use of Combination Vaccines United States

Prevent perinatal HBV transmission ( selective; 1988 – universal) Routine infant vaccination (1991) Catch-up vaccination 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 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 Screening of Pregnant Women, of Pregnant Women, StudyYear Births Reviewed, No. Mothers Screened, (%) New York (96) Kansas (84) National19933,982(84) Washington19944,031(96) Ohio (96) Illinois ,361(91) California19955,414(96) Florida (88) North Carolina (92) Delaware1999N/A(91) 8 states (EID sites) (96.5)

Identified and Expected Births to HBsAg-Positive Mothers United States, Expected Identified

HBsAg Seroprevalence among Pregnant Women by Prenatal Screening Status, Philadelphia, 1991 Prenatal Screening No. of Women TestedNo. (%) HBsAg-positive Yes (0.8) No20814 (6.7) Source: JAMA 1991;266:2852-5

Prevent perinatal HBV transmission ( selective; 1988 – universal) Routine infant vaccination (1991)Routine infant vaccination (1991) Catch-up vaccination 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 Strategy

HepB3, DTP3, and Hib3 Coverage, Among Month-Old Children, Routine HepB vaccination recommended HepB3 Hib3 DTP3

Reported Cases of Acute Hepatitis B in Children United States, Routine HepB vaccination recommended 1-4 years 5-9 years

Estimated Non-Perinatal HBV Infections Among Children <10 Years of Age United States, 1991 Source: Armstrong, et al. Pediatrics 2001; in press

Age of Acquisition for Persons with Chronic HBV Infection, United States Age of Acquisition for Persons with Chronic HBV Infection, United States Newborn, 18% Children, 18% Adolescent, 6% Adult, 59%

Prevent perinatal HBV transmission ( selective; 1988 – universal) Routine infant vaccination (1991) Catch-up vaccinationCatch-up vaccination year-old children (1995)11-12 year-old children (1995) All children <19 years of age (1997)All children <19 years of age (1997) Adults in high risk groups (1982) Elimination of Hepatitis B Virus Transmission United States Strategy

National vaccination coverage levels of adolescents years of age, NHIS

ALASKA CALIFORNIA IDAHO OREGON WASHINGTON MONTANA WYOMING UTAH COLORADO ARIZONA NEW MEXICO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA WISCONSIN IOWA ILLINOIS OHIO IN 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 year olds United States,

Hepatitis B vaccine doses distributed in public sector United States, Millions of doses 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”

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Vaccine coverage among infants born to unscreened women, Oregon, 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 Vaccines Concerns 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