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

Infant and Adolescent Hepatitis B Vaccination and Use of Combination Vaccines United States. Elimination of Hepatitis B Virus Transmission United States. Strategy. Prevent perinatal HBV transmission (1984 - selective; 1988 – universal) Routine infant vaccination (1991)

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

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  1. Infant and Adolescent Hepatitis B Vaccination and Use of Combination VaccinesUnited States

  2. Elimination of Hepatitis B Virus Transmission United States Strategy • 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)

  3. 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

  4. Evaluations of HBsAg Screening of Pregnant Women, 1991-2001 Births Reviewed, No. Mothers Screened, (%) Study Year 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)

  5. Identified and Expected Births to HBsAg-Positive Mothers United States, 1993-1999 19042 19250 19252 19617 19919 20254 20861 Expected 7874 8403 8002 8687 8841 8730 9503 Identified

  6. HBsAg Seroprevalence among Pregnant Women by Prenatal Screening Status, Philadelphia, 1991 Prenatal No. of Women HBsAg-positive Screening Tested No. (%) Yes 1555 12 (0.8) No 208 14 (6.7) Source: JAMA 1991;266:2852-5

  7. Elimination of Hepatitis B Virus Transmission United States Strategy • 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)

  8. HepB3, DTP3, and Hib3 Coverage, Among 19-35 Month-Old Children, 1992-2000 DTP3 Routine HepB vaccination recommended Hib3 HepB3

  9. Reported Cases of Acute Hepatitis B in ChildrenUnited States, 1985-2000 5-9 years Routine HepB vaccination recommended 1-4 years

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

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

  12. Elimination of Hepatitis B Virus Transmission United States Strategy • 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)

  13. National vaccination coverage levels of adolescents 13-15 years of age, NHIS

  14. States Requiring Hepatitis B Vaccination Before Middle School Entry, 2001 WASHINGTON MAINE NORTH MONTANA MINNESOTA DAKOTA OREGON VT NH WISCONSIN IDAHO SOUTH MA NEW DAKOTA YORK CT MICHIGAN WYOMING RI IOWA PENNSYLVANIA NEVADA NEBRASKA NJ OHIO IN DE UTAH ILLINOIS DC MD COLORADO WV VIRGINIA MISSOURI KANSAS KENTUCKY CALIFORNIA NO. CAROLINA TENNESSEE 31 of 50 States have HepB immunization requirements OKLAHOMA ARIZONA SO. ARKANSAS NEW CAROLINA MEXICO MS GEORGIA ALABAMA LA TEXAS ALASKA FL HAWAII

  15. Reported cases of acute hepatitis B among 15-18 year olds United States, 1990-2000

  16. Hepatitis B vaccine doses distributed in public sector United States, 1990-2000 Total Monovalent HepB Millions of doses Hib-HepB 18.3% 14.6% 8.5% 0.4%

  17. 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”

  18. HepB Doses Administered Before Age 2 Months Oregon Immunization Registry, 2/99 – 3/00 1200 Joint Statement 1000 Preservative-free HepB available through VFC 800 Hep B given 0-56 days after birth Preservative-free HepB available in hospitals 600 Doses Administered 400 Hep B given 0-5 days after birth 200 0 02 06 10 14 18 22 26 30 34 38 42 46 50 02 06 10 1999 2000 Source: Oregon Immunization ALERT registry Week

  19. Vaccine coverage among infants born to unscreened women, Oregon, 1999-2000 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

  20. 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

  21. 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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