1. Prevention of Perinatal and Childhood Hepatitis B Virus Infections Background on Where We’ve Been Lisa Jacques-Carroll, MSW Immunization Services Division, CDC

2. Hepatitis B: Burden of Disease - United States  ~60,000 new infections in 2004  200,000-300,000 new infections per year before hepatitis B vaccination programs  1 of 20 persons have been infected with hepatitis B virus (HBV) during their lifetime (about 12.5 million)  1 of 200 persons have chronic HBV infection (~1.25 million)  4000-5000 deaths from HBV related chronic liver disease (cirrhosis, liver cancer)

3. Chronic Liver Disease Caused by HBV Infection

4. Consequences of HBV Infection in Infants and Young Children ~90% of infants and 30% of children <5 yrs who acquire HBV infection become chronically infected~90% of infants and 30% of children <5 yrs who acquire HBV infection become chronically infected ~25% of those with chronic infection die prematurely of liver cancer or cirrhosis~25% of those with chronic infection die prematurely of liver cancer or cirrhosis

5. Newborn 18% Children 18% Adolescent 6% Adult 59% Sources: National Health and Nutrition Examination Survey III N Engl J Med 1989;321:1301-5 N Engl J Med 1989;321:1301-5 Pediatrics 1992;89:269-73 Pediatrics 1992;89:269-73 Pediatrics 1995;96:1113-6 Pediatrics 1995;96:1113-6 Estimated Age at Infection of Persons with Chronic HBV Infection Before Childhood Vaccination, US

6. Modes of HBV Transmission in Early Childhood Vertical transmission from mother to infant Vertical transmission from mother to infant Horizontal transmission from infected household contact to child Horizontal transmission from infected household contact to child  Both modes of transmission can be prevented by vaccination of newborns!

7. Vaccine Efficacy in Preventing Vertical HBV Transmission Without immunoprophylaxis, ~40% of infants of Hepatitis B Surface Antigen (HBsAg) positive mothers develop chronic HBV infectionWithout immunoprophylaxis, ~40% of infants of Hepatitis B Surface Antigen (HBsAg) positive mothers develop chronic HBV infection Immunoprophylaxis includes:Immunoprophylaxis includes: hepatitis B vaccine & Hepatitis B Immune Globulin (HBIG) at birthhepatitis B vaccine & Hepatitis B Immune Globulin (HBIG) at birth This is 85%-95% effective in preventing vertical HBV transmission; hepatitis B vaccine alone at birth prevents transmission in 70-95% of infantsThis is 85%-95% effective in preventing vertical HBV transmission; hepatitis B vaccine alone at birth prevents transmission in 70-95% of infants

8. Vaccine Efficacy in Preventing Horizontal HBV Transmission Before implementation of perinatal hepatitis B prevention programs, studies show:Before implementation of perinatal hepatitis B prevention programs, studies show: 61%-66% of children with chronic HBV infection were born to HBsAg-negative mothers61%-66% of children with chronic HBV infection were born to HBsAg-negative mothers Children likely were infected by household contacts*Children likely were infected by household contacts* Birth dose of hepatitis B vaccine will prevent these early childhood infectionsBirth dose of hepatitis B vaccine will prevent these early childhood infections *Pediatrics 1995; 96:1113-6; Pediatrics, 2001, 108:5, 1123-28

9. Strategy to Eliminate HBV Transmission in the United States Universal vaccination of infants beginning at birthUniversal vaccination of infants beginning at birth Prevention of perinatal HBV infectionPrevention of perinatal HBV infection Screen all pregnant women for HBsAgScreen all pregnant women for HBsAg Immunoprophylaxis of infants born to HBsAg-positive and unknown status womenImmunoprophylaxis of infants born to HBsAg-positive and unknown status women Vaccination of all previously unvaccinated children and adolescents < 19 yearsVaccination of all previously unvaccinated children and adolescents < 19 years Vaccination of previously unvaccinated adults in high risk groupsVaccination of previously unvaccinated adults in high risk groups

10. Reported Acute Hepatitis B Incidence by Age Group: US, 1990-2004 ≥20 years 12-19 years <12 years 71% decline 94% decline Year Cases per 100,000

11. Gaps in Prevention of Perinatal and Early Childhood Hepatitis B Virus Infections <50% of expected infants born to HBsAg-positive mothers are identified for case-management by public health<50% of expected infants born to HBsAg-positive mothers are identified for case-management by public health Medical errors in identifying and managing:Medical errors in identifying and managing: infants born to HBsAg-positive mothersinfants born to HBsAg-positive mothers infants born to mothers w/unknown HBsAg statusinfants born to mothers w/unknown HBsAg status <50% of all infants receive first dose at birth<50% of all infants receive first dose at birth

12. Identified and Expected Births to HBsAg-Positive Mothers, US, 1993-2003 Expected number Percent identified Source: National Immunization Program, CDC 48% 23,827 19,043 41%

13. Case Management Public health ensures case management of infants born to HBsAg-positive or unknown status women Post-exposure prophylaxis Hepatitis B series If mother is HBsAg-positive, serologic testing for hepatitis B status and immunity Case reviews show higher completion of prophylaxis, vaccine series, and testing among case managed infants* *Sources: Alabama Department of Public Health, 2004; MMWR 1996; 45:584-7

14. Medical Errors in Prevention of Perinatal HBV Transmission During July 1999-October 2002, public health reported more than 500 medical errorsDuring July 1999-October 2002, public health reported more than 500 medical errors Examples:Examples: Infants born to HBsAg-positive mothers did not receive hepatitis B vaccine and HBIG within 12 hrs of birthInfants born to HBsAg-positive mothers did not receive hepatitis B vaccine and HBIG within 12 hrs of birth Infants of mothers with unknown HBsAg status did not receive hepatitis B vaccine within 12 hrs of birthInfants of mothers with unknown HBsAg status did not receive hepatitis B vaccine within 12 hrs of birth HBsAg screening test results were misordered, misinterpreted, mistranscribed, or miscommunicatedHBsAg screening test results were misordered, misinterpreted, mistranscribed, or miscommunicated Incorrect hepatitis B screening tests orderedIncorrect hepatitis B screening tests ordered Source: Immunization Action Coalition

15. Perinatal Hepatitis B Death Michigan, 1999 3 month old baby girl died of fulminant hepatitis B Mother tested HBsAg positive during pregnancy Prenatal care provider: Made a transcription error and reported mother as “hepatitis negative” to the hospital Used 1966 prenatal form Did not report HBsAg positive test (Michigan law) Hospital staff: Relied on provider’s prenatal record Suspended routine birth dose of Hepatitis B vaccine due to thimerosal concern

16. Recent Errors in Large, Urban Hospital 2004-2005 Hospital failed to provide HBIG and birth dose of hepatitis B to 4 infants born to HBsAg-positive women Hospital received notification that the HBsAg-positive woman would deliver at their facility in 3 of the 4 cases Hospital cited transcription errors, delayed receipt of lab results, and other mistakes as reasons for these medical errors

17. Receipt of Hepatitis B Vaccine at Birth Among Infants Born to Women with Unknown HBsAg Status* StudyYear # infants identified Rec’d Prophylaxis National199364022% Washington199412553% California199520020% Florida19953829% Ohio19953566% Oregon20004319% Michigan20005714% State health department surveys of hospital records * State health department surveys of hospital records

18. Proportion of Infants Receiving Hepatitis B Vaccine Birth Dose, 1999-2004 46.0% 53.7% Source: CDC, National Immunization Survey Hepatitis B Vaccine 0-2 Days from Birth

19. Hepatitis B Vaccine Birth Dose Coverage*, 2004 <30 30-39 9 No. of states Coverage % 7 40-49 50-59 5 60-6915 70-795 >802 0-2 days from birth * 0-2 days from birth 7

20. Rationale for Hepatitis B Vaccine Birth Dose for All Infants Provides “safety net” for prevention of perinatal HBV infections Provides “safety net” for prevention of perinatal HBV infections Prevents early childhood HBV infections, including infections among children born to HBsAg-negative women Prevents early childhood HBV infections, including infections among children born to HBsAg-negative women Associated with higher rates of on-time completion of hepatitis B vaccine series, and at times, with higher completion rates of other vaccines Associated with higher rates of on-time completion of hepatitis B vaccine series, and at times, with higher completion rates of other vaccines

21. Perinatal and Childhood HBV Infections, Summary Substantial progress in implementing routine infant hepatitis B vaccinationSubstantial progress in implementing routine infant hepatitis B vaccination New HBV infections in children declined 94%New HBV infections in children declined 94% Gaps in eliminating transmission remainGaps in eliminating transmission remain New ACIP recommendations address these gapsNew ACIP recommendations address these gaps