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9. Findings, Conclusions, and Recommendations
Pages 121-142

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From page 121...
... The committee suggests that the potential global health benefit of a vaccine takes precedence in determining its initial ranking for accelerated development priority. The "affordability" of benefits, represented by the potential expenditures on vaccines, can be entered into the decision process, if desired, and the techniques for doing so are illustrated with the central analysis.
From page 122...
... · estimates of the number of new entrants to the respective target populations, as described in Appendixes D-1 through D-l9 and summarized in Chapter 7, Table 7.1 · times to licensure and adoption, delay of vaccination benefits presented in Chapter 7, Table 7.2 calculations of each vaccine candidate's potential health benefits and associated expenditures as described in Chapters 4 and 7 · a 5 percent discount rate for future health benefits and costs · a perspective, for illustrative purposes only, on the undesirability of various morbidity conditions and mortality, derived from the median values of responses from a range of health professionals in developing countries · independent consideration of each disease and the development of each vaccine candidate (for each target population) · expression of health benefits in units considered equivalent in undesirability to the death of an infant (i.e., infant mortality equivalents, see Chapter 4)
From page 123...
... Specifically, Annualized present annualized present value of potential annualized present value of potential health benefit = value of potential - expenditures adjusted for health benefit $ willingness to opportunity cost pay per IME averted Table 9.3 shows, for the various vaccine candidates, the annualized present values of potential health benefits adjusted for opportunity costs at various levels of willingness to pay per IME averted. Positive values reflect the relative size of benefits for vaccines that are "affordable" at that level of willingness to pay.
From page 125...
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From page 127...
... 127 Ul 0 ·rl ·rl CJ o ·rl sol pa o ·rl erl So o I: CO 4 ·H Cal a, q4 O P ~ .
From page 128...
... and possibly other antigens Genetically engineered 145, 260 attenuated strains 69, 171,586 Conjugated polyeaccharide 210,943 526,603,421 Attenuated live virus Polypeptide recombinant vaccine produced in yeast Polypeptide produced by recombinant DNA technology Inactivated virus produced in cell culture 15, 112 1, 058, 021, 429 14,392 4,028,950,683 213, 192 8, 859, 258,746 3,232 613,959,820 Mycobacterium leprae Armadillo-derived M. leprae 88,481 270,619,575 (Immuno-prophylactic: all children in endued c areas . I~no-therapeutic: all recently infected individuals)
From page 129...
... 129 Expenditure per IME Prevented Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $100,000/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $10,000/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cast at $1,000/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $500/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $100/IME 25,298 7,140 -14,622 -232,246 -474,049 -2,408,479 5,712 119,231 54,226 -595,831 -1,318,116 -7,096,394 476 144,568 138,343 76,088 6,917 -546,456 2,496 205,677 158,283 -315,660 -842,264 -5,055,091 279,946 70,014 4,531 -90,691 -1,042,910 -2,100,931 -10,565,103 -25,898 -388,503 -4,014,559 -8,043,509 -40,275,115 41,555 124,600 -672,734 -8,646,066 -17,505,325 -88,379,395 189,944 -2,907 -58,164 -610,727 -1,224,687 -6,136,366 3,058 85,775 61,419 -182,138 -452,758 -2,617,714 51,483 6,673 -57,057 -694,360 -1,402,474 -7,067,387 38,843 26,721 -126,020 -1.653,432 -3,350,556 -16,927,548 2,035 465,532 378,478 -492,066 -1,459,338 -9,197,511 2a008 418.072 340,956 —430,203 -1,287,047 —8,141,795
From page 130...
... virus containing gene for protective glycoprotein antigen Respiratory Polypeptides produced by 52,412 1,964,436,106 syncytial virus recombinant DNA technology (Infants) Attenuated live virus 59,559 982,843,053 Rotavirus Attenuated high passage 521,852 852,737,494 (Infants, 0-6 months)
From page 131...
... lit Expenditure per IME Prevented Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $100.000/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $10,000/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $1,000/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $500/IME Annualized Present Value of Potential Health Benefits Adjusted for Opportunity Cost at $100/IME 3,503 40,442 27,229 -104,901 -251,713 -1,426,205 3,650 36,596 24,117 -100,673 -239,328 -1,348,570 1,877 8,105 6,709 -7,246 -22,752 -146,802 37,480 32,768 -144,031 -1,912,024 -3,876,460 -19,591,949 16,502 49,731 —38,725 —923,284 —la906,127 —9,768,871 1,634 513,325 436,578 -330,885 -1,183,623 -8,005,523 1,454 444,242 385,256 -204,600 -859,995 -6,103,158 1,455 444,237 385,206 -205,100 -860,995 -6,108,158 830 427,891 395,667 73,431 -284,608 -3,148,926 781 193,224 179,530 42,592 -109,562 -1,326,789 412 221,180 212,936 130,492 38,889 -693,942 3,070 174,971 125,096 -373,655 -927.823 -5,361,165 961 1,350,840 1,232,914 53,652 -1,256,638 -11,738,964 250 94,748 92.607 71,197 47,408 -142,902 665 65,112 61,191 21,976 -21,595 -370,168 8,362 10,197 1,822 -81,922 -174,971 -919,366
From page 132...
... Procedures are discussed in Chapter 3. However, because the expenditures do not reflect overall net costs, the committee believes that initial rankings of candidates should be based on their potential health benefits.
From page 133...
... Using the lower DBV of 1,921,300 as the starting point in the analysis results in a value for the annualized present value of potential health benefits (APVPHB)
From page 134...
... Discount Rate The committee believes that incorporating a discounting procedure for future health benefits and expenditures is justified because it reflects the preference for benefits achieved sooner- rather than later (a basic concept in the establishment of a program of accelerated vaccine development)
From page 135...
... which drops from position 9 on health benefits to position 15 if a 10 percent discount rate is adopted. Although the development of this second generation vaccine is relatively advanced, it drops in position when a high discount rate is adopted (i.e., one that favors shorter term realization of benefits)
From page 136...
... 136 A: · pod o pa to N ·rl 0 o V ·rl a 44 o C)
From page 137...
... 137 pi so a, Sol a, N JO ·,1 ~ · ¢ o a)
From page 138...
... CONCLUSIONS Final decisions on the number of vaccines and the particular vaccines selected for accelerated development must incorporate various nonquantifiable factors, as well as information provided by the rankings that were derived with the proposed system for calculating benefits and expenditures. The additional factors include: · goals of the responsible agency and its schedule for achieving them · ethical questions on the distribution of benefits among socioeconomic or age groups, countries, or regions · most appropriate points in the development process at which the agency can exert influence and the opportunity and need for such influence .
From page 139...
... · arguments for treating certain vaccine development projects as unique because of their potential for facilitating immunization programs in general {e.g., by eliminating constraints on delivery, such as poor stability) or by improving public confidence {e.g., by reducing adver se r eact ions ~ · the prospect that a part icular project may serve as a useful model for a number of other desired vaccines · disease related factors, such as epidemiologic and to overwhelm medical services, and clinical characteristics likely to overwhelm medical services, and the availability of alternative control strategies or safe and effective therapy · possible synergistic interaction with other diseases
From page 140...
... interest in diseases that may be imported into the United States, that threaten travelers or personnel stationed overseas, or that are existing problems in the United States · the affordability of the potential health benefit, if not already used formally in the decision process These factors are discussed in more detail in Chapter 8 and elsewhere in the report. The analyses presented in this chapter indicate that of the 29 ~ ~ for S
From page 141...
... In this light, the committee suggests additional analyses and research to provide further information on the key elements that may alter decisions. Ideally, to fully assess the effect of alternative IME profiles on the rankings, calculations should be conducted using the whole range of individual sets of IME values.
From page 142...
... Better data bases in these areas would facilitate making rational choices on vaccine development priorities and vaccine formulation. Therefore, NIAID and other national and international organizations should consider means to improve available epidemiological data on infectious diseases.


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