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B Candidate Disease Profiles and Data 127

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128 RANKING VACCINES: A Prioritization Framework Influenza disease profile BOX B-1 Influenza Infectious Agent: Orthomyxoviruses, RNA viruses that infect birds and mammals. Three genera cause influenza: Influenza A, which is the most common cause of disease and has varying serotypes; Influenza B, which has only one serotype; and Influenza C, the least common. Routes of Transmission: Airborne aerosols and direct contact with se- cretions or contaminated surfaces. Health Effects: Influenza illness typically begins with chills or fever. The illness often involves cough, sore throat, nasal congestion, muscle aches, headache, and fatigue. It typically lasts for several days. In contrast with common colds, influenza usually has high fever with sudden onset and extreme fatigue. Influenza can also cause pneumonia either directly or through secondary bacterial infection. Incidence, Prevalence, and Mortality: Influenza causes annual seasonal epidemics throughout the world as well as periodic pandemics. In the United States influenza has been estimated to cause an average of approximately 36,000 annual deaths during 1990–1999 and 226,000 an- nual hospitalizations during 1979–2001.

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129 Appendix B The incidence (or attack rate) varies from year to year and is highest in children aged 0 to 4 years old and in the elderly aged 65 years and older. One paper from the Centers for Disease Control and Prevention estimated seasonal influenza attack rates in the United States ranging from 6.6 percent in healthy young adults to 20 percent in the youngest children. The 2009 pandemic influenza virus A (H1N1) infected an esti- mated 11 to 21 percent of the populations where the incidence could be studied. The highest incidence (34–43 percent) occurred in school-aged children. The severity of the disease, in terms of hospitalizations and pneumonia, was similar to that of recent seasonal influenza strains. Prevention and Treatment: Annual influenza vaccination is the primary tool for prevention. The vaccine is reformulated each year to prevent the strains of the virus that the World Health Organization predicts will be most prevalent during the coming year. In addition, antiviral treatment is most effective when initiated within 48 hours of symptom onset and has typically been directed to persons at high risk of complications due to influenza. Vaccine: In the United States, vaccination has been recommended for all persons 6 months and older since 2006. Two types of vaccines are produced: inactivated (for intramuscular administration) and live attenu- ated (for intranasal administration).

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130 RANKING VACCINES: A Prioritization Framework Tuberculosis disease profile BOX B-2 Tuberculosis Infectious Agent: Mycobacteria in the M. tuberculosis complex, primarily M. tuberculosis, M. bovis, and M. africanum. Routes of Transmission: Inhaling droplet nuclei in airborne aerosols gen- erated by coughing or sneezing by individuals with pulmonary tubercu- losis and consuming contaminated, unpasteurized cow’s milk. Health Effects: In a small proportion of newly infected individuals, espe- cially infants, initial infection progresses rapidly—in weeks to months—to primary tuberculosis, which often disseminates to blood, bone, and other distant sites. Pulmonary tuberculosis produces cough, fever, night sweats, fatigue, and weight loss; it often goes undiagnosed for a number of months, during which time infection is transmitted to others, espe- cially to close contacts, such as household members. However, infection in the lung can be contained by the immune system and remains latent; fewer than 10 percent of latently infected individuals subsequently de- velop reactivation pulmonary tuberculosis, generally when age, malnu- trition, HIV infection, or other conditions suppress the immune system and thereby allow latent infection to reactivate. Incidence, Prevalence, and Mortality: Approximately one-third of the world’s population is estimated to be latently infected with M. tuber- culosis, but only a small proportion of these individuals will develop tuberculosis. WHO estimated that in 2010, 8.8 million people developed tuberculosis worldwide, yielding an incidence of 128 cases per 100,000 people. About 650,000 cases were caused by multi-drug-resistant strains of M. tuberculosis, and 1.4 million with tuberculosis died of the

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131 Appendix B disease. The incidence rate, number of cases, and deaths from tubercu- losis has been declining in recent years, mainly due to increased at- tention and resources devoted to diagnosing cases and assuring that patients receive and complete the lengthy treatment regimen. Prevention: In most wealthy countries with low incidence rates, preven- tion of tuberculosis primarily rests on prompt diagnosis, correct multi- drug treatment, and ensuring completion of treatment among those with pulmonary tuberculosis. Latent infected individuals are also treated with drugs, especially those at high risk of reactivation tuberculosis, such as HIV-infected individuals. In poor countries with high incidence rates of tuberculosis, prevention of tuberculosis, while also dependent on prompt diagnosis, correct treatment, and ensuring completion of treatment, primarily rests on targeting all infants with a single dose of the vaccine, given shortly after birth. Treatment: Successful treatment of tuberculosis requires multiple drugs (at least three) given for a lengthy time period (9 to 12 months), even though the patient is usually asymptomatic (and non-infectious) after a few weeks of treatment. Treatment of latently infected individuals to prevent reactivation tuberculosis is generally accomplished with a single drug (example, isoniazid), also given for an extended period of time (6 to 12 months). Vaccine: Bacille Calmette-Guerin (BCG) vaccine is widely used at birth throughout South Africa, where there is a high burden of pediatric HIV infection. BCG is given to all newborns as soon as possible after birth to protect infants infected with tuberculosis from progressing to the more dangerous forms of meningeal and miliary tuberculosis.

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132 RANKING VACCINES: A Prioritization Framework Group B streptococcus disease profile BOX B-3 Group B Streptococcus Infectious Agent: Group B Streptococcus (Streptococcus agalactiae) is a gram-positive organism found as a normal inhabitant of the gas- trointestinal and genital tract of humans. The majority of the disease is caused by five serotypes. Routes of Transmission: Transmission from mother to infant occurs in utero or at the time of delivery. Exposure to GBS in the hospital, at home, or in the community may result in late-onset disease. Health Effects: Group B Streptococcus (Streptococcus agalactiae) is a leading cause of disease in young children. There are two distinct pre- sentations: Early-onset disease (days of life 0–6) is the result of vertical transmission from a colonized mother, and late-onset disease (days of life 7–89) is acquired from either the mother or environmental sources. Early-onset disease is characterized by sepsis or meningitis with a high mortality rate. Late-onset disease often presents as meningitis with a somewhat lower mortality rate but with prominent sequelae. Incidence, Prevalence, and Mortality: Group B Streptococcus is the most common cause of sepsis and meningitis in infants from developed countries and one of the most common causes in infants globally. The mean invasive GBS disease incidence is 0.53 per 1,000 live births. The mean incidence of early-onset disease is 0.43 per 1,000 live births, with

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133 Appendix B the highest incidence reported from Africa: 0.53 per 1,000 live births. The mean incidence of late-onset disease (7–89 days) is 0.24 per 1,000 live births. Incidence is again highest in Africa, at 0.7 per 1,000 live births. Typically, early-onset disease is more likely to cause mortality (case fatality rate of 12.1 percent) than the late-onset disease (case fatal- ity rate of 6.8 percent). Prevention: Currently, to control group B streptococcus intrapartum antibitotics are administered to pregnant women with either known risk factors for group B streptococcos or documented carriage of the bac- teria. This approach was widely adopted in the United States and many developed countries and resulted in substantial declines in disease in in- fants younger than 7 days. In the United States, culture-based screening is used to identify candidates for chemoprophylaxis, but implementing this strategy has been a difficult in low- and middle-income countries. Treatment: Supportive care and antibiotics are needed for the success- ful treatment of GBS in infants. Benzylpenicillin or amoxicillin combined with aminoglycosides is the mainstay of therapy at the onset when GBS is suspected. When GBS is confirmed, benzylpenicillin or amoxicillin can be used as a single agent. Treatment duration for sepsis is generally 10 days, but meningitis is treated for a minimum of 14 days, with more pro- longed therapy in complicated cases. Vaccine: A vaccine is not currently available for group B streptococcal infection.

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U.S. Population Data Femalea Population Life Table Health Productivity 134 Living Life Years Life Expectancy Standard Life Hourly Wage Rated Age Group N (lx) (nLx) (ex) Expectancyb (ex) HUI2c *(<15 parents) <1 2,183,518 100,000 99,452 80.9 86.5 0.99 $17.90 1–4 8,456,004 99,391 397,326 80.4 85.7 0.99 $17.97 5–9 10,228,540 99,292 496,309 76.5 81.7 0.99 $23.50 10–14 10,309,899 99,232 495,991 71.6 76.8 0.99 $24.57 15–19 10,910,307 99,164 495,387 66.6 71.8 0.99 $8.45 20–24 10,862,866 98,991 494,371 61.7 66.9 0.99 $10.90 25–29 10,634,528 98,758 493,104 56.9 62 0.95 $16.40 30–34 10,326,394 98,484 491,541 52 57.1 0.90 $16.47 35–39 10,441,258 98,133 489,384 47.2 52.2 0.86 $18.20 40–44 10,944,157 97,621 486,111 42.4 47.3 0.86 $18.20 45–49 11,697,857 96,823 481,067 37.7 42.5 0.84 $18.50 50–54 11,270,132 95,603 473,634 33.2 37.8 0.84 $18.50 55–59 9,904,308 93,850 463,085 28.8 33.1 0.81 $18.70 60–64 8,297,733 91,384 447,776 24.5 28.5 0.81 $18.70 65–69 6,266,131 87,726 425,003 20.4 24 0.83 $16.07 70–74 4,919,414 82,275 391,682 16.6 19.7 0.83 $16.00 75–79 4,159,980 74,398 344,041 13.1 15.5 0.82 $16.00 80–84 3,493,449 63,218 278,259 9.9 11.8 0.82 $16.00 85–89 2,397,331 48,086 195,937 7.3 8.5 0.82 $16.00 90–94 1,194,178 30,289 104,147 5.1 5.8 0.82 $15.00 95–99 422,524 14,523 38,597 3.4 3.8 0.82 $15.00

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Malea Population Life Table Health Productivity Living Life Years Life Expectancy Standard Life Hourly Wage Rated Age Group N (lx) (nLx) (ex) Expectancyb (ex) HUI2c *(<15 parents) <1 2,294,679 100,000 99,348 76 79.6 0.99 $17.90 1–4 8,889,066 99,276 396,817 75.6 78.8 0.99 $17.97 5–9 10,753,934 99,156 495,604 71.7 74.9 0.99 $23.50 10–14 10,838,788 99,085 495,185 66.7 69.9 0.99 $24.57 15–19 11,472,812 98,989 493,905 61.8 65 0.99 $9.25 20–24 11,374,397 98,573 491,150 57 60.1 0.99 $11.45 25–29 11,021,998 97,887 487,775 52.4 55.2 0.95 $17.90 30–34 10,581,472 97,223 484,373 47.7 50.4 0.92 $17.97 35–39 10,547,351 96,526 480,477 43.1 45.6 0.88 $23.50 40–44 10,872,790 95,665 475,151 38.4 40.8 0.88 $23.50 45–49 11,447,885 94,396 467,208 33.9 36.1 0.86 $24.57 50–54 10,825,136 92,487 455,327 29.6 31.5 0.86 $24.57 55–59 9,393,752 89,643 438,424 25.4 27.1 0.83 $24.62 60–64 7,674,399 85,726 415,226 21.5 23 0.83 $24.65 65–69 5,587,609 80,364 383,132 17.7 18.9 0.86 $20.90 70–74 4,156,592 72,889 339,373 14.3 15.2 0.86 $19.00 75–79 3,219,109 62,860 281,766 11.2 11.7 0.84 $19.00 80–84 2,359,608 49,846 209,856 8.4 8.7 0.84 $19.00 85–89 1,318,716 34,096 131,028 6.2 6.3 0.84 $19.00 90–94 486,989 18,315 58,224 4.4 4.4 0.84 $18.00 95–99 112,289 7,198 17,589 3 3 0.84 $18.00 a The country life tables are available from WHO Global Health Observatory Data Repository (http://bit.ly/HyByvk). 135 b Standard life expectancy depicts the life expectancy for the Japanese population. Data available through WHO Global Health Observatory Data Repository (http://bit.ly/Ho2VI3). c HUI-2 scores are derived from: Fryback, D. G., N. C. Dunham, M. Palta, J. Hanmer, J. Buechner, D. Cherepanov, S. Herrington, R. D. Hays, R. M. Kaplan, and T. G. Ganiats. 2007. U.S. norms for six generic health-related quality-of-life indexes from the National Health Measurement study. Medical Care 45(12):1162–1170. d Hourly wage rate was gathered from the Bureau of Labor Statistics Wages. The parents’ wage rate was used for children under the age of 15 years.

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U.S. data for influenza 136 Disease Burden Female Target Vaccine Annual Vaccine Herd Population Age Population Incidence Ratea Case Fatality Coverage Effectivenessb Immunity Groups (N) (% of N) (per 100,000) Ratea (%) (%) (%) Thresholdc (%) ( <1) 2,183,518 100% 20,300 0.004 30% 60% 100% (1–19) 39,904,750 100% 11,947 0.002 20% 70% 100% (20–64) 94,379,233 100% 6,600 0.05 40% 75% 100% ( >65) 22,853,007 100% 9,000 1.17 60% 40% 100% Male Target Annual Vaccine Vaccine Herd Population Age Population Incidence Ratea Case Fatality Coverage Effectivenessb Immunity Groups (N) (% of N) (per 100,000) Ratea (%) (%) (%) Thresholdc (%) ( <1) 2,294,679 100% 20,300 0.004 30% 60% 100% (1–19) 41,954,600 100% 11,947 0.002 20% 70% 100% (20–64) 93,739,180 100% 6,600 0.05 40% 75% 100% ( >65) 17,240,912 100% 9,000 1.17 60% 40% 100% a Molinari, N. A., I. R. Ortega-Sanchez, M. L. Messonnier, W. W. Thompson, P. M. Wortley, E. Weintraub, C. B. and Bridges. 2007. The annual impact of seasonal influenza in the US: Measuring disease burden and costs. Vaccine 25(27):5086–5096. b Allison, M. A., M. F. Daley, L. A. Crane, J. Barrow, B. L. Beaty, N. Allred, S. Berman, and A. Kempe. 2006. Influenza vaccine effectiveness in healthy 6- to 21-month-old children during the 2003–2004 season. Journal of Pediatrics 149(6):755–762. e751; Nichol, K. L. 2003. The efficacy, effectiveness and cost-effectiveness of inactivated influenza virus vaccines. Vaccine 21(16):1769–1775; Vu, T., S. Farish, M. Jenkins, H. and Kelly. 2002. A meta-analysis of effectiveness of influenza vaccine in persons aged 65 years and over living in the community. Vaccine 20(13–14):1831– 1836. c Herd immunity threshold is assumed to be at 100 percent due to the infectious nature of Influenza.

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Disease Morbidity and Vaccine Complications Percent Disutilitya Disability Durationc Disease Morbidity of Cases (Toll) Weightb (Years) Influenza Illness Without 59.5% 0.09 0.01 0.0137 Outpatient Visit Influenza Illness With 40.0% 0.13 0.1 0.0137 Outpatient Visit Influenza Hospitalization 0.5% 0.2 0.3 0.0137 a Probability Disutility Disability Durationc Vaccine Complications per Dose (Toll) Weightb (Years) Guillain-Barré Syndrome 0.000001 0.35 0.44 0.137 Systemic Reaction 0.011 0.25 0.1 0.0027 (Fever or Achiness) Anaphylaxis 0.00000025 0.25 0.44 0.0027 a Disutility (toll) is the one-time disutility associated with the specific health state. Fryback, D. G., N. C. Dunham, M. Palta, J. Hanmer, J. Buechner, D. Cherepanov, S. Herrington, R. D. Hays, R. M. Kaplan, and T. G. Ganiats. 2007. U.S. norms for six generic health-related quality-of-life indexes from the National Health Measurement study. Medical Care 45(12):1162–1170. b Mathers, C. D., A. D. Lopez, C. J. L. and Murray. 2006. The burden of disease and mortality by condition: data, methods, and results for 2001. Global burden of disease and risk factors. Table 3A.6. Global burden of disease 2004 update: Disability weights for diseases and conditions 1:45–93. c Committee’s expert opinion. 137

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Vaccine Characteristics 142 Length of immunity a life years or life a Doses required per person 1 doses a Cost per dose $50 $ a Cost to administer per dose $25 $ Research costs a $100,000,000 $ Licensure costs a $500,000,000 $ a Start-up costs $10,000,000 $ a Time to adoption 5 years a Since BCG is not administered in the United States, these values are based on expert opinion.

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U.S. data for Group B streptococcus Disease Burden Female Annual Incidence Herd Target Ratea Vaccine Case Vaccine Immunity Population Population Effectivenessb Age (per Fatality Coverage Thresholdc Groups (N) (% of N) 100,000) Ratea (%) (%) (%) (%) ( <1) 2,183,518 100% 35.00 3.8 85% 90% 100% (1–19) 39,904,750 0% 1.37 6.3 85% 90% 100% (20–64) 94,379,233 0% 4.60 6.0 85% 80% 100% ( >65) 22,853,007 0% 25.30 11.4 85% 80% 100% Male Annual Herd Target Incidence Case Vaccine Vaccine Immunity Population Population Age Ratea (per Fatality Coverage Effectivenessb Thresholdc Groups (N) (% of N) 100,000) Ratea (%) (%) (%) (%) ( <1) 2,294,679 100% 35.00 3.8 85% 90% 100% (1–19) 41,954,600 0% 1.37 6.3 85% 90% 100% (20–64) 93,739,180 0% 4.60 6.0 85% 80% 100% ( >65) 17,240,912 0% 25.30 11.4 85% 80% 100% a Phares, C. R., R. Lynfield, M. M. Farley, J. Mohle-Boetani, L. H. Harrison, S. Petit, A. S. Craig, W. Schaffner, S. M. Zansky, and K. Gershman, 2008. Epidemiology of invasive group B streptococcal disease in the United States, 1999–2005. JAMA 299(17):2056–2065. b Since a vaccine for group B streptococcus is not available currently, the effectiveness values are derived from expert opinions. c A herd immunity threshold of 100 percent is assigned for all age groups. 143

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Disease Morbidity 144 Percent Disutilitya Disability Durationc of Cases (Toll) Weightb (Years) Meningitis 25% 0.70 0.61 0.04 Pneumonia 20% 0.13 0.15 0.04 Respiratory distress 15% 0.13 0.14 0.02 Sepsis 15% 0.09 0.09 0.03 Neurological impairment 25% 0.35 0.4 a Fryback, D. G., N. C. Dunham, M. Palta, J. Hanmer, J. Buechner, D. Cherepanov, S. Herrington, R. D. Hays, R. M. Kaplan, and T. G. Ganiats. 2007. U.S. norms for six generic health-related quality-of-life indexes from the National Health Measurement study. Medical Care 45(12):1162–1170. b Mathers, C. D., A. D. Lopez, and C. J. L. Murray. 2006. The burden of disease and mortality by condition: data, methods, and results for 2001. Global burden of disease and risk factors. Table 3A.6. Global burden of disease 2004 update: Disability weights for diseases and conditions 1: 45–93. c Committee’s expert opinion. Costs Disease Health Care Respiratory Neurological Services Cost Death Meningitis Pneumonia Distress Sepsis Impairment Hospitalizationa $2,100 7 14 7 7 2 14 a Committee’s expert opinion and the HCUP Nationwide Inpatient Sample Data, 2009.

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Vaccine Characteristics Length of immunitya life years or life a Doses required per person 1 doses Cost per dosea $100 $ Cost to administer per dosea $50 $ a Research costs $200,000,000 $ a Licensure costs $600,000,000 $ a Start-up costs $10,000,000 $ Time to adoptiona 5 years a Since a vaccine for group B streptococcus does not currently exist, these values are based on expert opinion. 145

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South Africa Population Data Femalea Population Life Table Health Productivity Standard Life 146 Life Years Life Expectancy Expectancyb Hourly Wage Rated Age Group N Living (lx) (nLx) (ex) (ex) HUI2c *(<15 parents) <1 504,851 100,000 97,376 54.9 86.5 0.99 $4.48 1–4 2,061,888 96,251 381,263 56 85.7 0.99 $4.49 5–9 2,556,786 94,692 471,476 52.9 81.7 0.99 $5.88 10–14 2,475,823 93,899 467,978 48.3 76.8 0.99 $6.14 15–19 2,498,988 93,293 463,506 43.6 71.8 0.99 $2.11 20–24 2,518,633 92,109 450,195 39.1 66.9 0.99 $2.73 25–29 2,300,308 87,968 420,123 35.9 62 0.95 $4.10 30–34 1,904,419 80,081 378,913 34.1 57.1 0.90 $4.12 35–39 1,623,918 71,485 342,388 32.9 52.2 0.86 $4.55 40–44 1,432,625 65,471 317,762 30.7 47.3 0.86 $4.55 45–49 1,290,971 61,634 298,340 27.5 42.5 0.84 $4.63 50–54 1,169,991 57,702 277,578 24.2 37.8 0.84 $4.63 55–59 960,397 53,329 254,939 21 33.1 0.81 $4.68 60–64 727,265 48,647 230,430 17.8 28.5 0.81 $4.68 65–69 556,744 43,525 199,866 14.6 24 0.83 $4.02 70–74 385,054 36,421 162,843 11.9 19.7 0.83 $4.00 75–79 239,133 28,716 120,284 9.4 15.5 0.82 $4.00 80–84 124,578 19,397 78,061 7.8 11.8 0.82 $4.00 85–89 52,649 11,827 44,731 6.1 8.5 0.82 $4.00 90–94 16,257 6,066 19,618 4.6 5.8 0.82 $3.75 95–99 2,969 2,496 6,380 3.2 3.8 0.82 $3.75

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Malea Population Life Table Health Productivity Standard Life Hourly Wage Rated Life Years Life Expectancy Expectancyb Age Group N Living (lx) (nLx) (ex) (ex) HUI2c *(<15 parents) <1 513,738 100,000 96,596 53.9 79.6 0.99 $4.48 1–4 2,094,078 95,137 375,325 55.6 78.8 0.99 $4.49 5–9 2,587,325 92,961 463,390 52.9 74.9 0.99 $5.88 10–14 2,495,950 92,395 460,642 48.2 69.9 0.99 $6.14 15–19 2,514,105 91,862 457,000 43.4 65 0.99 $2.31 20–24 2,542,121 90,938 450,001 38.8 60.1 0.99 $2.86 25–29 2,384,897 89,062 437,942 34.6 55.2 0.95 $4.48 30–34 2,053,143 86,115 416,874 30.7 50.4 0.92 $4.49 35–39 1,700,601 80,634 386,196 27.6 45.6 0.88 $5.88 40–44 1,372,882 73,844 350,118 24.9 40.8 0.88 $5.88 45–49 1,157,933 66,203 312,525 22.5 36.1 0.86 $6.14 50–54 1,004,315 58,807 275,919 20.1 31.5 0.86 $6.14 55–59 814,859 51,561 238,876 17.5 27.1 0.83 $6.16 60–64 598,768 43,989 202,138 15.1 23 0.83 $6.16 65–69 413,005 36,866 163,729 12.5 18.9 0.86 $5.23 70–74 246,008 28,626 124,506 10.4 15.2 0.86 $4.75 75–79 131,479 21,177 86,228 8.2 11.7 0.84 $4.75 80–84 57,263 13,315 51,119 6.6 8.7 0.84 $4.75 85–89 18,099 7,133 25,265 5.1 6.3 0.84 $4.75 90–94 4,082 2,973 8,783 3.8 4.4 0.84 $4.50 95–99 550 946 2,185 2.8 3 0.84 $4.50 a The country life tables are available from WHO, Global Health Observatory Data Repository (http://bit.ly/HyByvk). b Standard life expectancy depicts the life expectancy for the Japanese population. Also available through WHO, Global Health Observatory Data Repository (http://bit.ly/Ho2VI3). 147 c HUI-2 scores are derived from: Fryback, D. G., N. C. Dunham, M. Palta, J. Hanmer, J. Buechner, D. Cherepanov, S. Herrington, R. D. Hays, R. M. Kaplan, and T. G. Ganiats. 2007. U.S. norms for six generic health-related quality-of-life indexes from the National Health Measurement study. Medical Care. 45(12):1162–1170. Due to the lack of data for HUI-2 within South Africa, estimates for the United States are used. d Wage Rate for South Africa was crudely estimated by converting the United States wage rate to a South African wage based on the prevailing exchange rate.

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South Africa Data for Tuberculosis Disease Burden 148 Female Annual Herd Target Incidence Case Vaccine Vaccine Immunity Age Population Population Ratea (per Fatality Coveragec Effectivenessd Threshold Groups (N) (% of N) 100,000) Rateb (%) (%) (%) (%) <1 50,4851 100% 800 19 50% 60% 100% 1–19 9,593,485 0% 900 19 50% 60% 100% 20–64 13,928,527 0% 1100 22 50% 50% 100% >65 1,377,384 0% 981 20 50% 40% 100% Male Annual Herd Target Incidence Case Vaccine Vaccine Immunity Age Population Population Ratea (per Fatality Coveragec Effectivenessd Threshold Groups (N) (% of N) 100,000) Rateb (%) (%) (%) (%) <1 513,738 100% 800 19 50% 60% 100% 1–19 9,691,458 0% 973 19 50% 60% 100% 20–64 13,629,519 0% 1200 22 50% 50% 100% >65 870,486 0% 981 20 50% 40% 100% a WHO. 2011. Global Tuberculosis Control 2011. b Corbett, E. L., C. J. Watt, N. Walker, D. Maher, B. G. Williams, M. C. Raviglione, and C. Dye. 2003. The growing burden of tuberculosis: Global trends and interactions with the HIV epidemic. Archives of Internal Medicine 163(9):1009–1021. c Vaccine coverage assumed to be 50 percent. d Colditz, G. A., T. F. Brewer, C. S. Berkey, M. E. Wilson, E. Burdick, H. V. Fineberg, and F. Mosteller. 1994. Efficacy of BCG vaccine in the prevention of tuberculosis. JAMA 271(9):698–702; Rahman, M., M. Sekimoto, I. Takamatsu, K. Hira, T. Shimbo, K. Toyoshima, and T. Fuku. 2001. Economic evaluation of universal BCG vaccination of Japanese infants. International Journal of Epidemiology 30(2):380–385; Rodrigues, L. C., V. K. Diwan, and J. G. Wheeler. 1993. Protective effect of BCG against tuberculous, meningitis, and miliary tuberculosis: A meta-analysis. International Journal of Epidemiology 22(6):1154–1158.

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Disease Morbidity and Vaccine Complications Percent Disutilityb Disability Durationa Disease Morbidity of Casesa (Toll) Weightc (Years) Pulmonary Tuberculosis 40% 0.30 0.28 0.06 (with Inpatient Treatment) Pulmonary Tuberculosis 20% 0.08 0.27 0.16 (with Outpatient Treatment) Latent Tuberculosis 8% 0.00 0.00 0.00 (with Treatment) Extrapulmonary Tuberculosis 22% 0.30 0.29 0.06 (with Inpatient Treatment) Lung Impairment 10% 0.08 0.29 Probability Disutility Disability Duration Vaccine Complications per Dosea (Toll)b Weightc (Years)a Injection Site Abscess 0.000010 0.05 0.1 0.082100 Lymphadenitis 0.000010 0.05 0.01 0.043000 Severe Local Reaction 0.000050 0.05 0.1 0.008200 a Committee’s expert opinion. b Guo, N., F. Marra, and C. A. Marra. 2009. Measuring health-related quality of life in tuberculosis: A systematic review. Health and Quality of Life Outcomes 7:14. c Mathers, C. D., A. D. Lopez, and C. J. L. Murray. 2006. The burden of disease and mortality by condition: data, methods, and results for 2001. Global Burden of Disease and Risk Factors. Table 3A.6. Global burden of disease 2004 update: Disability weights for diseases and conditions 1:45–93. 149

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150 Costs Disease Morbidity Pulmonary Pulmonary Latent Tuberculosis Tuberculosis Tuberculosis Extrapulmonary Lung Health Care Services Cost Death (Inpatient) (Outpatient) with Treatment Tuberculosis Impairment Direct Observed Therapy $46 0 0 0 1 0 0 (DOT) Drugsa Outpatient Treatmenta $250 0 0 1 0 0 0 a Inpatient Treatment $637 0 1 0 0 3 0 b Hospitalization $360 1 0 0 0 0 5 Vaccine Complications Injection Severe Local Health Care Services Cost Site Abscess Lymphadenitis Reaction Direct Observed Therapy $46 0 0 0 (DOT) Drugsa Outpatient Treatmenta $250 1 1 0 a Inpatient Treatment $637 0 0 1 b Hospitalization $360 0 0 0 a Floyd, K., D. Wilkinson, and C. Gilks. 1997. Comparison of cost effectiveness of directly observed treatment (DOT) and conventionally delivered treatment for tuberculosis: Experience from rural South Africa. British Medical Journal 315(7120):1407–1411. Sinanovic, E., and L. Kumaranayake. 2006. Cost effectiveness and resource allocation. Cost Effectiveness and Resource Allocation 4:11. b WHO. 2011. Econometric estimation of unit costs. WHO-CHOICE 2011 unit cost estimates for service delivery, http://bit.ly/GWGwF1.

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Vaccine Characteristics Length of immunitya life years or life Doses required per persona 1 doses a Cost per dose $25 $ a Cost to administer per dose $50 $ a Research costs $200,000,000 $ Licensure costsa $600,000,000 $ Start-up costsa $10,000,000 $ a Time to adoption 5 years a Committee’s expert opinion. 151

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