4
Immunization

Hepatitis B is a vaccine-preventable disease for which a safe and effective vaccine has been available for nearly three decades. The first part of this chapter reviews current federal vaccination recommendations and state vaccination requirements for hepatitis B. It also summarizes what is known about hepatitis B vaccination rates in specific populations (for example, infants, children, and adults, including subgroups of at-risk adults, such as incarcerated people and occupationally exposed people). The committee identified missed opportunities for hepatitis B vaccination and makes recommendations to increase the vaccination rate among various populations.

A vaccine for hepatitis C does not exist. The second part of this chapter summarizes current efforts to develop a hepatitis C vaccine and challenges that have been encountered. The committee makes a recommendation about hepatitis C vaccine development.

HEPATITIS B VACCINE

The first hepatitis B vaccine, a plasma-derived vaccine, was licensed by the US Food and Drug Administration (FDA) in 1981 (IOM, 1994). By the late 1980s, the plasma-derived vaccine was replaced with a recombinant version, which expresses the hepatitis B surface antigen (HBsAg) and is produced in Saccharomyces cerevisiae (common baker’s yeast). The recombinant vaccine was licensed by FDA in 1986 and is the type of hepatitis B vaccine currently used in the United States. It is an anticancer vaccine: by preventing hepatitis B, it prevents hepatocellular carcinoma.



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4 Immunization H epatitis B is a vaccine-preventable disease for which a safe and ef- fective vaccine has been available for nearly three decades. The first part of this chapter reviews current federal vaccination recommenda- tions and state vaccination requirements for hepatitis B. It also summarizes what is known about hepatitis B vaccination rates in specific populations (for example, infants, children, and adults, including subgroups of at-risk adults, such as incarcerated people and occupationally exposed people). The committee identified missed opportunities for hepatitis B vaccination and makes recommendations to increase the vaccination rate among vari- ous populations. A vaccine for hepatitis C does not exist. The second part of this chapter summarizes current efforts to develop a hepatitis C vaccine and challenges that have been encountered. The committee makes a recommendation about hepatitis C vaccine development. HEPATITIS B vACCINE The first hepatitis B vaccine, a plasma-derived vaccine, was licensed by the US Food and Drug Administration (FDA) in 1981 (IOM, 1994). By the late 1980s, the plasma-derived vaccine was replaced with a recombinant version, which expresses the hepatitis B surface antigen (HBsAg) and is produced in Saccharomyces cerevisiae (common baker’s yeast). The recom- binant vaccine was licensed by FDA in 1986 and is the type of hepatitis B vaccine currently used in the United States. It is an anticancer vaccine: by preventing hepatitis B, it prevents hepatocellular carcinoma. 0

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0 HEPATITIS AND LIVER CANCER Hepatitis B vaccine is available both as single-antigen formulations and as multiantigen formulations in fixed combination with other vac- cines (Mast et al., 2005). The two single-antigen vaccines are Recom- bivax HB® (Merck & Co., Inc., Whitehouse Station, NJ) and Engerix-B® (GlaxoSmithKline Biologicals, Rixensart, Belgium). Of the three licensed combination vaccines, Twinrix® (GlaxoSmithKline Biologicals, Rixensart, Belgium) is used for vaccination of adults, and Comvax® (Merck & Co., Inc., Whitehouse Station, NJ) and Pediarix® (GlaxoSmithKline Biologicals, Rixensart, Belgium) are used for vaccination of infants and young children. Twinrix contains recombinant HBsAg and inactivated hepatitis A virus. Comvax contains recombinant HBsAg and Haemophilus influenzae type b (Hib) polyribosylribitol phosphate conjugated to Neisseria meningitidis outer-membrane protein complex. Pediarix contains recombinant HBsAg, diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), and inactivated poliovirus. The hepatitis B vaccine is administered in a three-dose series: two priming doses administered 1 month apart and a third dose administered 6 months after the second (Mast and Ward, 2008). Alternative schedules have been used successfully. Administration of the three-dose series results in protective concentrations of anti-HBs in more than 95% of healthy infants, children, and adolescents and in more than 90% of healthy adults aged 40 years old and younger. Immunogenicity drops below 90% in adults over the age of 40 years. The hepatitis B vaccine has a pre-exposure efficacy of 80–100% and a postexposure efficacy of 70–95%, depending on whether hepatitis B immune globulin (HBIG) is given with the vaccine. The duration of immunity appears to be long-lasting, and booster doses of the vaccine are not routinely recommended (Mast and Ward, 2008). HBIG is derived from plasma and is used prophylactically to prevent infection with the hepatitis B virus (HBV). It provides passively acquired antibody to hepatitis B surface antigen (anti-HBsAg) and temporary protec- tion (3–6 months). HBIG is typically used as an adjunct to hepatitis B vac- cine for postexposure immunoprophylaxis to prevent HBV infection (Mast et al., 2005). HBIG administered alone is the primary means of protection after an HBV exposure for people who do not respond to hepatitis B vac- cination. It is also used after liver transplantation for end-stage hepatitis B to prevent recurrence of the disease in the transplanted liver. Current vaccination Recommendations, Requirements, and Rates The Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the US Department of Health and Human Services and the US Centers for Disease Control and Prevention (CDC) on the con- trol of vaccine-preventable diseases. It develops written recommendations

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 IMMUNIZATION for the routine administration of vaccines to children and adults in the civilian population. The ACIP recommendations for who should receive the hepatitis B vaccine are summarized in Box 4-1. The American Academy of Pediatrics in its Report of the Committee on Infectious Diseases follows the ACIP recommendations for the hepatitis B vaccine (American Academy of Pediatrics, 2009). Perinatal vaccination ACIP first recommended universal hepatitis B vaccination of infants in 1991 (ACIP, 1991). Despite the recommendation, each year about 1,000 newborns in the United States acquire chronic HBV infection (Ward, 2008), a number that has not declined in the last decade. That constitutes an im- portant gap that needs to be addressed in future prevention efforts. ACIP currently recommends that the first dose—that is, the birth dose—be administered before hospital discharge in infants born to HbsAg- negative women and within 12 hours of birth in infants born to women who are HbsAg-positive or of unknown status (Mast et al., 2005). It also recommends that infants born to HBsAg-positive mothers should be given HBIG within 12 hours of birth. There is no evidence of appreciable ben- efit if HBIG is administered more than 72 hours after birth. The timely identification of HBsAg-positive mothers to prevent perinatal transmis- sion underscores the need for rapid hepatitis B tests (discussed further in Chapter 5). The hepatitis B vaccine series should be completed by the age of 18 months (see Table 4-1). Depending on which type of vaccine (single- antigen or combination) is administered, the series can consist of three or four vaccinations. Current ACIP hepatitis B vaccine recommendations for preterm infants who weigh less than 2,000 g are summarized in Table 4-2. For preterm infants, the first dose of the vaccine is given within 12 hours of birth if the mother is HBsAg-positive or is of unknown status. If the mother is known to be HbsAg-negative, the first dose is administered at the age of 1 month or at hospital discharge (Mast et al., 2005). The preterm-infant schedule is based on the recognition that preterm infants have a decreased response to hepatitis B vaccine administered before the age of 1 month. Data from National Immunization Surveys demonstrate that national newborn hepatitis B vaccination coverage did not change appreciably after implementation of the 2005 ACIP hepatitis B vaccination recommenda- tion (CDC, 2009b). Using National Immunization Survey data that were collected before implementation of the 2005 ACIP hepatitis B vaccination recommendation, CDC estimated that the national newborn hepatitis B vaccination coverage was 46%, 47.9%, and 42.8% at the age of 1 day in the 2004, 2005, and 2006 surveys (CDC, 2008c, 2009b). Using data

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 HEPATITIS AND LIVER CANCER BOX 4-1 Summary of ACIP Hepatitis B Vaccination Recommendations Vaccination of infants At birth • nfants born to mothers who are HbsAg-positive should receive hepa- I titis B vaccine and HBIG within 12 hours of birth. • nfants born to mothers whose HBsAg status is unknown should re- I ceive hepatitis B vaccine within 12 hours of birth. The mother should have blood drawn as soon as possible to determine her HBsAg status; if she is HbsAg-positive, the infant should receive HBIG as soon as possible (no later than the age of 1 week). • ull-term infants who are medically stable, weigh over 2,000 g, and F are born to HBsAg-negative mothers should receive single-antigen hepatitis B vaccine before hospital discharge. • reterm infants weighing less than 2,000 g and born to HbsAg- P negative mothers should receive the first dose of vaccine 1 month after birth or at hospital discharge. After the birth dose • ll infants should complete the hepatitis B vaccine series with either A single-antigen vaccine or combination vaccine according to a recom- mended vaccination schedule. • nfants born to HBsAg-positive mothers should be tested for HBsAg I and antibody to HBsAg after completion of the hepatitis B vaccine series at the age of 9–18 months. Vaccination of children and adolescents • ll unvaccinated children and adolescents less than 19 years old A should receive the hepatitis B vaccine series. from the 2007 National Immunization Survey, which were collected after implementation of the 2005 ACIP recommendation, CDC estimates that the national newborn hepatitis B vaccine coverage was 46% at the age of 1 day (CDC, 2009b). As noted above, despite the ACIP recommendation to vaccinate all newborns, about 1,000 newborns each year become chronically infected with HBV. Even with the ACIP recommendation, birth doses of the hepati-

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 IMMUNIZATION Vaccination of adults Persons at risk for infection by sexual exposure • ex partners of HbsAg-positive persons. S • exually active persons who are not in a long-term, mutually mo- S nogamous relationship (for example, persons with more than one sex partner during the previous 6 months). • ersons seeking evaluation or treatment for a sexually transmitted P disease. • en who have sex with men. M Persons at risk for infection by percutaneous or mucosal exposure to blood • Current or recent injection-drug users. • Household contacts of HBsAg-positive persons. • esidents and staff of facilities for developmentally disabled R persons. • ealth-care and public-safety workers who have a reasonably antici- H pated risk of exposure to blood or blood-contaminated body fluids. • ersons with end-stage renal disease, including predialysis, hemodi- P alysis, peritoneal-dialysis, and home-dialysis patients. • Incarcerated persons. Others • nternational travelers to regions that have high or intermediate levels I (HBsAg prevalence of at least 2%) of endemic HBV infection. • Persons who have chronic liver disease. • Persons who have HIV infection. • ll other persons who are seeking protection from HBV infection. A Abbreviations: ACIP, Advisory Committee on Immunization Practices; HBsAg, hepatitis B surface antigen; HBIG, hepatitis B immune globulin. SOURCE: Adapted from Mast et al., 2005, 2006. tis B vaccine are being missed or delayed, which the committee believes is due to the lack of a delivery-room policy for hepatitis B vaccination. Miss- ing or delaying the birth dose for infants born to HBsAg-positive women substantially increases the risk that they will develop chronic hepatitis B. To reduce the incidence of perinatal HBV infections, the committee offers the following recommendation:

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 HEPATITIS AND LIVER CANCER TABLE 4-1 Hepatitis B Vaccine Schedules for Newborns, by Maternal HBsAg Status—ACIP Recommendations Maternal Single-Antigen (Stand-alone) Single Antigen (Stand-alone) + HbsAg Status vaccine Combination vaccine Dose Age Dose Age 1a 1a Positive Birth (up to 12 hours) Birth (up to 12 hours) HBIGb Birth (up to 12 hours) HBIG Birth (up to 12 hours) 2 1–2 months 2 2 months 3c 6 months 3 4 months 4c 6 months (Pediarix) or 12–15 months (Comvax) 1a Unknownd 1a Birth (up to 12 hours) Birth (up to 12 hours) 2 1–2 months 2 2 months 3c 6 months 3 4 months 4c 6 months (Pediarix) or 12–15 months (Comvax) 1a,e 1a,e Negative Birth (before Birth (before discharge) discharge) 2 1–2 months 2 2 months 3c 6–18 months 3 4 months 4c 6 months (Pediarix) or 12–15 months (Comvax) aRecombivax HB or Engerix-B should be used for the birth dose. Comvax and Pediarix cannot be administered at birth or before the age of 6 weeks. bHBIG (0.5 mL) administered intramuscularly in a separate site from vaccine. cFinal dose in vaccine series should not be administered before the age of 24 weeks. dMothers should have blood drawn and tested for HBsAg as soon as possible after admis- sion for delivery; if mother is found to be HbsAg-positive, infant should receive HBIG as soon as possible but no later than the age of 7 days. eOn a case-by-case basis and only in rare circumstances, first dose may be delayed until after hospital discharge for an infant who weighs ≤2,000 g and whose mother is HbsAg-negative, but only if physician’s order to withhold birth dose and copy of mother’s original HBsAg- negative laboratory report are documented in infant’s medical record. Abbreviations: HBsAg, hepatitis B surface antigen; ACIP, Advisory Committee on Immuniza- Immuniza- tion Practices; HBIG, hepatitis B immune globulin. HBIG, SOURCE: Mast et al., 2005.

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 IMMUNIZATION TABLE 4-2 Hepatitis B Immunization Management of Preterm Infants Who Weigh Less Than 2,000 g, by Maternal HBsAg Status—ACIP Recommendations Maternal HBsAg Status Recommendation Positive HBIG + hepatitis B vaccine (within 12 hours of birth) Continue vaccine series beginning at age of 1–2 months according to recommended schedule for infants born to HBsAg-positive mothers (see Table 4-1) Do not count birth dose as part of vaccine series Test for HBsAg and antibody to HBsAg after completion of vaccine series at age of 9–18 months (that is, next well-child visit) Unknown HBIG + hepatitis B vaccine (within 12 hours of birth) Test mother for HBsAg Continue vaccine series beginning at age of 1–2 months according to recommended schedule based on mother’s HBsAg result (see Table 4-1) Do not count birth dose as part of vaccine series Negative Delay first dose of hepatitis B vaccine until age of 1 month or hospital discharge Complete vaccine series (see Table 4-1) Abbreviations: ACIP, Advisory Committee on Immunization Practices; HBIG, hepatitis B im- mune globulin; HBsAg, hepatitis B surface antigen. SOURCE: Mast et al., 2005. Recommendation 4-1. All infants weighing at least 2,000 grams and born to hepatitis B surface antigen-positive women should receive single-antigen hepatitis B vaccine and hepatitis B immune globulin in the delivery room as soon as they are stable and washed. The recom- mendations of the Advisory Committee on Immunization Practices should remain in effect for all other infants. Administration of prophylaxis in the delivery room is not novel. In the United States, vitamin K prophylaxis for vitamin K–deficiency bleeding and tetracycline or erythromycin for prophylaxis of neonatal gonococcal infections are routinely given to infants in the delivery room (American Academy of Pediatrics, 1961, 1980; Workowski and Berman, 2006). The World Health Organization recommends that the birth dose of the hepatitis B vaccine be administered as soon after birth as possible (WHO, 2006). A pilot project in The Lao People’s Democratic Republic demonstrated almost 100% coverage when the hepatitis B vaccine was administered in

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 HEPATITIS AND LIVER CANCER the delivery room (WHO, 2006). When mothers were asked to take their newborns to a vaccination room for their hepatitis B vaccine birth dose, vaccine coverage was low. Childhood vaccination ACIP recommends that unvaccinated children and adults under 19 years old be given the hepatitis B vaccine series (Mast et al., 2005). Stud- ies have found racial and ethnic disparities in childhood vaccination rates: Asian and Pacific Islander (API), Hispanic, and black children had lower vaccination rates than non-Hispanic white children (CDC, 2000; Darling et al., 2005; Jenkins et al., 2000; Morita et al., 2008; Szilagyi et al., 2002). However, when poverty was controlled for, the estimates did not remain sig- nificantly lower for any racial or ethnic population than for non-Hispanic white children (CDC, 2009c). Studies have also found geographic variability in vaccination cover- age (Darling et al., 2005; Morita et al., 2008; Szilagyi et al., 2002). The disparities are seen state by state and within regions. For instance, in 2008, Maryland had the highest percentage of children who were up to date1 on their vaccinations with a rate of 82.3%, compared with Montana with a rate of 59.2% (CDC, 2009c). Szilagyi et al. (2002) looked at the use of reminder and recall interventions by primary-care providers to increase immunization rates for children under 2 years old. Before the intervention, the baseline geographic disparity was an 18% difference between inner- city children (55%) and suburban children (73%). Within 3 years of the establishment of the intervention, the vaccination rates had increased in all areas, including 84% in the inner city and 88% in the suburbs. All but three states—Alabama, Montana, and South Dakota—have a childhood hepatitis B vaccination mandate for daycare or school en- try (Immunization Action Coalition, 2009). A retrospective cohort study of Chicago public-school children found that the hepatitis B vaccination school-entry mandate led to an increase in the vaccination rate among all children and substantially decreased the disparity in the vaccination rate between white children and black and Hispanic children (Morita et al., 2008). Before the school-entry mandate, the study found immunizations rates in non-Hispanic white, black, and Hispanic children of 89%, 76%, and 74%, respectively. After the mandate was enacted, the rates changed to 1 The immunization series used in these data includes the following vaccinations—4 or more doses of DTaP, 3 or more doses of poliovirus vaccine, 1 or more dose of any measles-contain- ing vaccine, 3 or more doses of Hib vaccine, 3 or more doses of hepatitis B vaccine, as well as 1 or more dose of varicella vaccine (CDC, 2009c).

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 IMMUNIZATION 88%, 81%, and 87%, respectively. Although a disparity in the vaccinations rates persisted, the gap was narrowed (Szilagyi et al., 2002). Other studies also have found that school-entry mandates are effec- tive in increasing hepatitis B vaccination rates (CDC, 2001b; Koff, 2000; Olshen et al., 2007; Zimet et al., 2008) although such mandates may not be as effective in children in daycare (Stanwyck et al., 2004). CDC (2007) found that about 75% of states reported at least 95% hepatitis B vaccination coverage of children in kindergarten in 2006–2007. Another study reported that hepatitis B vaccine series coverage for children 19–35 months old in 2000–2002 ranged from 49% to 82%, depending on the state (Luman et al., 2005). Special attention needs to be given to vaccination coverage of foreign- born children from countries that have a high prevalence of hepatitis B; because of their high risk of prior infection, laboratory testing is indicated to determine HBV-infection status. Recommendation 4-2. All states should mandate that the hepatitis B vaccine series be completed or in progress as a requirement for school attendance. Parents of foreign-born children from HBV-endemic countries should be given information about testing for HBV and should have their children tested before vaccination. Adult vaccination Hepatitis B vaccination for adults is recommended to high-risk populations—people at risk for HBV infection from infected household contacts and sex partners, from occupational exposure to infected blood or body fluids, and from travel to regions with high or intermediate levels of endemic HBV infection (Mast et al., 2006). The estimated chance that an acute HBV infection will become chronic decreases with increasing age (see Table 4-3). The probability that an acute HBV infection in a 1-year-old will become chronic is 88.5%, but only 9.0% in a 19-year-old (Edmunds et al., 1993). Universal hepatitis B vaccination for adults is not recommended (that is, people born before 1991 do not need to receive the hepatitis B vac- cine unless they are at risk for HBV infection). It is not cost-effective; that is, the health benefits achieved do not justify the cost compared with other potential health-care interventions (Gold et al., 1996). Interventions in the United States that cost less than $100,000 per quality adjusted life year (QALY) gained are generally considered to be cost-effective (Owens, 1998; WHO, 2009). Universal hepatitis B vaccination is not cost-effective even in adult Asians and Pacific Islanders, who have a higher prevalence of HBV

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 HEPATITIS AND LIVER CANCER TABLE 4-3 Estimated Chance That an Acute Hepatitis B Infection Becomes Chronic with Age Estimated Chance That Acute HBv Infection Age (years) Becomes Chronic (%) 1 88.5 2 52.5 3 41.3 4 34.6 5 29.8 6 26.1 7 23.3 8 20.9 9 19.0 10 17.3 11 15.9 12 14.7 13 13.6 14 13.0 15 11.7 16 11.0 17 10.3 18 9.6 19 9.0 NOTE: Calculated using a formula from Edmunds et al., 1993. infection than the general US population (Hutton et al., 2007). However, ring vaccination—vaccination of the close contacts of people found to be chronically infected with HBV—is cost-effective (Hutton et al., 2007). Figure 4-1 shows estimated cost effectiveness of hepatitis B vaccination for different age groups and different incidences of acute hepatitis B. The leftmost line of the graph represents a recent estimate of acute HBV inci- dence in the general US population (Hutton et al., 2007). This estimate is expressed as the annual percentage of people in the population who acquire acute HBV infection. At that incidence, hepatitis B vaccination of adults in the general US population costs more than $100,000 per QALY gained, and is not considered to be cost-effective. In 2004, just over half (54.6%) the adults at high risk for HBV infection had received the hepatitis B vaccine, including about 75% of health-care workers and 64% of public-safety workers for whom vaccination is recom- mended (CDC, 2006; Simard et al., 2007). Of adults with acute hepatitis B, 61% reported having missed an opportunity for vaccination (Williams et al., 2005). Low coverage of high-risk adults is attributed to the lack of dedicated vaccine programs, limited vaccine supply, inadequate funding, and noncompliance by the involved populations (Mast et al., 2006).

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 IMMUNIZATION 50 40 Age of Person Vaccinated 30 Cost per QALY Gained >$200,000 $150,000-$200,000 20 $100,000-$150,000 0.0050% 0.0150% 0.0250% 0.0350% 0.0450% 0.0550% 0.0650% 0.0750% $50,000-$100,000 $0-$50,000 Annual Incidence of Acute HBV Infection FIGuRE 4-1 Estimated cost of adult hepatitis B vaccination per quality adjusted life year (QALY) gained for different age groups and different rates of acute hepatitis B virus (HBV) infection incidence. Incidence is expressed as the annual percentage of the population becoming acutely infected with HBV (for example, incidence of 0.005% means that 5 persons per 100,000 are acutely infected with HBV each year, and incidence of 0.075% means that 75 persons per 100,000 are acutely infected with HBV Figure 4-1, editable different levels of cost per QALY gained. In- each year). Shadings show terventions are more cost-effective as one moves down (lower age) and to the right (higher incidence). Interventions that cost less than approximately $100,000 per QALY gained are generally considered cost-effective in the United States (Owens, 1998; WHO, 2009). The leftmost line, incidence of 0.0050%, is based on a recent estimate of acute hepatitis B incidence in the general US population (Hutton et al., 2007). Analysis performed by D. Hutton using the model developed in Hutton et al., 2007. Adults at Risk from Sexual Exposure In a national sample of 500 sexually- transmitted-disease (STD) clinics, the percentage that offered the hepatitis B vaccine increased from 25% to 45% (p = 0.02) from 1997 to 2001, and the percentage of the clinics that considered all patients eligible for the vac- cine rose from 9% to 26% (p = 0.023) during the same period (Gilbert et al., 2005). However, declining hepatitis B vaccination rates were reported in a study of six STD clinics in the United States (Harris et al., 2007). The researchers collected data on patient visits and hepatitis B vaccinations for

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 HEPATITIS AND LIVER CANCER sis (March 2001–July 2002), pneumococcal conjugate (September 2001– March 2003 and February 2004–September 2004), measles–mumps–rubella (October 2001–July 2002), and varicella (October 2001–August 2002) (Jacobson et al., 2006). Although there has not been a national shortage of the hepatitis B vaccine, temporary supply problems occurred with this vaccine in 2008 (adult and dialysis formulations of Recombivax HB) and 2009 (pediatric formulations of Recombivax HB and Pediatric Engerix-B) (CDC, 2009a). A shortage was avoided because other manufacturers were able to provide an adequate supply of the vaccine in adult and dialysis formulations, and CDC released doses of pediatric vaccine from its stockpile. Recommendation 4-6. The federal government should work to ensure an adequate, accessible, and sustainable hepatitis B vaccine supply. HEPATITIS C vACCINE Efforts are going on to develop a vaccine for hepatitis C, and several candidates are in phase I and phase II clinical trials (Inchauspe and Michel, 2007). Although some vaccines are being developed to treat people with chronic HCV infection (that is, therapeutic vaccines), this section focuses on vaccines to prevent chronic HCV infection. An incomplete understanding of how chronic HCV infection is spontaneously controlled in some people and antigenic variability of the virus remain barriers to development of a vaccine to prevent chronic hepatitis C. Feasibility of Preventing Chronic Hepatitis C The outcomes of HCV infections in humans and chimpanzees suggest that it may be possible to develop a vaccine to prevent HCV infection. Spontaneous clearance of the virus in 15–45% of persons after acute HCV infection demonstrates that immunity can prevent chronic infection and its long-term consequences, such as cirrhosis and hepatocellular carcinoma (HCC) (Alter et al., 1992; Barrera et al., 1995; Villano et al., 1999; Vogt et al., 1999). It also seems that immunity can be conditioned by prior ex- posure: humans and chimpanzees that recover from HCV infection appear to control a second infection better (the peak of viremia is lower than in the initial infection, and the chance of recovery is greater compared with that in persons not previously infected) (Lanford et al., 2004; Major et al., 2002; Mehta et al., 2002). In addition, IDUs who recovered from earlier HCV infections and have continuing HCV exposure have substantially less viremia than those who have similar exposure but had no earlier infection

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 IMMUNIZATION (Mehta et al., 2002). Some hepatitis C vaccine candidates have shown similar potential (Forns et al., 2000; Weiner et al., 2001). Although those clinical observations suggest that it is possible to de- velop a vaccine to prevent chronic HCV infection, there are important chal- lenges. Immunity produced by natural infection does not prevent reinfection (that is, it is not sterilizing); such immunity reduces the frequency of chronic infection but does not prevent it (Farci et al., 1992). Moreover, the im- munologic correlates of those critical clinical outcomes are not sufficiently understood for rational design or evaluation of vaccine products. Marked genetic variability in some HCV epitopes creates an especially formidable challenge if immunity to them is necessary for protection. Need for a vaccine to Prevent Chronic Hepatitis C Although HCV infections occur in the general population of the United States and other economically developed countries, the incidence is prob- ably too low to justify universal HCV vaccination. A hepatitis C vaccine is most likely to benefit populations that are at highest risk, include IDUs, health-care workers who perform high-risk procedures, and some men who report high-risk sexual practices with other men. A vaccine that prevents chronic HCV infection not only might reduce the likelihood of long-term disease, such as cirrhosis or HCC, but might reduce the likelihood of secondary transmission by reducing the infection reservoir. It may not be possible to produce a vaccine that prevents HCV infection, but a product that prevents acute HCV infections from becoming chronic would probably achieve many of the same benefits. In cases where acute HCV infection does not resolve within a few months, early treatment can prevent most cases from evolving into chronic HCV infection. However, because most acute HCV infections are not recognized, a vaccine is further likely to be of great- est benefit to populations in whom acute infection is rarely recognized and treated (for example, IDUs). Cost Effectiveness of a Hepatitis C vaccine Estimates of the cost effectiveness of hepatitis C vaccination depend on a number of factors, including the cost of the vaccine, the target popu- lation’s incidence, and projections of its effectiveness and duration. Several studies have evaluated the potential cost effectiveness of an HCV vaccine that prevents acute (and chronic) infection. Krahn et al. (2005) calculated that if a hepatitis C vaccine with 80% efficacy was available, had a dura- tion of effectiveness equivalent to that of the hepatitis B vaccine, and was cost-equivalent to that of the current hepatitis A vaccine ($51 per dose plus administration fees), it would be cost saving to vaccinate IDUs. The authors

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 HEPATITIS AND LIVER CANCER also reported that vaccination of average-risk school-age children with such a vaccine would be cost-effective. The cost would be about $18,000 per QALY gained. Massad et al. (2009), on the basis of HCV incidence data for Sao Paolo, Brazil, calculated that a 100% effective hepatitis C vaccine that provides lifelong immunity and costs $300 per dose would cost $748,991 per death averted. If only high-risk people (for example, IDUs) were vacci- nated, the cost would be $131,305 per death averted. If the hepatitis C vac- cine had only 80% efficacy and lifelong duration, it would cost $242,667 per death averted if given only to high-risk people. The committee recognizes the need for a safe, effective, and affordable hepatitis C vaccine. Such a vaccine could substantially enhance hepatitis C prevention efforts. Recommendation 4-7. Studies to develop a vaccine to prevent chronic hepatitis C virus infection should continue. REFERENCES ACIP (Advisory Committee on Immunization Practices). 1991. Hepatitis B virus: A com- prehensive strategy for eliminating transmission in the United States through univer- sal childhood vaccination. Recommendations of the immunization practices advisory committee (ACIP). Morbidity and Morality Weekly: Recommendations and Reports 40(RR-13):1-25. Allred, N. J., K. M. Shaw, T. A. Santibanez, D. L. Rickert, and J. M. Santoli. 2005. Parental vaccine safety concerns: Results from the national immunization survey, 2001-2002. American Journal of Preventive Medicine 28(2):221-224. Allred, N. J., J. M. Stevenson, M. Kolasa, D. L. Bartlett, R. Schieber, K. S. Enger, and A. Shefer. 2006. Using registry data to evaluate the 2004 pneumococcal conjugate vaccine shortage. American Journal of Preventive Medicine 30(4):347-350. Alter, M. J., H. S. Margolis, K. Krawczynski, F. N. Judson, A. Mares, W. J. Alexander, P. Y. Hu, J. K. Miller, M. A. Gerber, R. E. Sampliner, et al. 1992. The natural history of com- com- munity-acquired hepatitis C in the United States. The sentinel counties chronic non-A, non-B hepatitis study team. New England Journal of Medicine 327(27):1899-1905. Altice, F. L., R. D. Bruce, M. R. Walton, and M. I. Buitrago. 2005. Adherence to hepatitis B virus vaccination at syringe exchange sites. Journal of Urban Health 82(1):151-161. American Academy of Pediatrics. 1961. Vitamin K compounds and the water-soluble ana- logues: Use in therapy and prophylaxis in pediatrics. Pediatrics 28:501-507. ———. 1980. Prophylaxis and treatment of neonatal gonococcal infections. Pediatrics 65(5): 1047-1048. ———. 2008. State legislation report. http://www.aap.org/advocacy/statelegrpt.pdf (accessed August 21, 2009). ———. 2009. Section 3. Summaries of infectious diseases: hepatitis B. Edited by L. K. Pickering, C. J. Baker, D. W. Kimberlin, and S. S. Long, Red book: 00 report of the committee on infectious diseases. Elk Grove Village, IL: American Academy of Pediatrics. Ashton, M. R., R. L. Cook, H. C. Wiesenfeld, M. A. Krohn, T. Zamborsky, S. H. Scholle, and G. E. Switzer. 2002. Primary care physician attitudes regarding sexually transmitted diseases. Sexually Transmitted Diseases 29(4):246-251.

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