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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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Suggested Citation:"References." Institute of Medicine. 2004. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press. doi: 10.17226/10782.
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References Abbotts, B., and L. Osborn.1993. Immunization Status and Reasons for Immunization Delay Among Children Using Public Health Immunization Clinics. American Journal of Dis- eases of Children 147~9~:965-968. Academy for Health Services Research and Health Policy [AHSRHP]. 2001. Understanding the Dynamics of "Crowd-Out": Defining Public/Private Coverage Substitution for Policy and Research. Washington, DC: Academy for Health Services Research and Health Policy. American Academy of Family Physicians.2001. Letter to the Centers for Medicare and Medicaid Services (December 19~. American Academy of Pediatrics. 2001a. Letter to the Centers for Medicare and Medicaid Ser- vices (December 21~. . 2001b. Letter to the Occupational Health and Safety Administration [OSHA] July 25~. _. 2002. Medicaid Reimbursement Survey, 2001: 50 States and the District of Columbia. No date. Accessed online November 29, 2002 at http://www.aap.org/research/medreim PDF01 /all_states.PDF. . 2003. Mandated Insurance Coverage of Childhood Vaccines (March 8~. American Association of Health Plans. 2002. Vaccine Purchasing Survey (August). American College of Physicians-American Society of Internal Medicine. 2001. Letter to the Centers for Medicare and Medicaid Services (September 26~. Arnould, R., and L. DeBrock. 1993. Equilibrium Outcomes in Vaccine Markets and the Im- plications for Policy Initiatives. In: Supplying Vaccines: An Economic Analysis of Critical Issues. Pauly, M., C. Robinson, S. Sepe, M. Sing, and M. Willian (eds.~. London: IOS Press. _. 2002. An Overview of the Market for Vaccines in the United States. Unpublished. (Avail- able from IOM.) Aventis Pasteur. 2002. Aventis Pasteur. Email Communication from C. Grant. November 22. (Available from IOM.) Bates, A., and F. Wolinsky. 1998. Personal, Financial, and Structural Barriers to Immuniza- tion in Socioeconomically Disadvantaged Urban Children. Pediatrics 101~4~:591-596. Batson, A. 2001. Understanding the Vaccine Market and Its Economics: Obstacles and Potential Solutions. Presentation to the Out of the Box Group, July 26, 2001. 211

212 FINANCING VACCINES IN THE 21ST CENTURY Boyd, T., R. Linkins, K. Mason, I. Bulim, and B. Lemke. 2002. Assessing Immunization Reg- istry Data Completeness in Bexar County, Texas. American Journal of Preventive Medicine 22~3~:184-187. Brichacek, A. 2001. Vaccine Worries. Pharmaceutical Executive 21. Briss, P., S. Zaza, and M. Pappaioanou. 2000. Reviews of Evidence regarding Interventions to Improve Vaccination Coverage in Children, Adolescents and Adults. American Jour- nal of Preventive Medicine 18~1S):97-140. Bureau of Labor Statistics.2003. Tables from the Current Population Survey, March 2001. Email from P. Willis, July 15. (Available from IOM.) Butler, P. 2000. ERISA and State Health Care Access Initiatives: Opportunities and Barriers. New York: The Commonwealth Fund. Centers for Disease Control and Prevention. 1984. Diphtheria-Tetanus-Pertussis Vaccine Shortage United States. Morbidity and Mortality Weekly Report 33~49~:695-696. . 1991. Food and Drug Administration Approval of Use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine. Morbidity and Mortality Weekly Report 40~50~:881-882. . 1992. Acellular Pertussis Vaccine for Reinforcing and Booster Use B Supplementary ACIP Statement. Morbidity and Mortality Weekly Report 41(RR-1~:1-10. . 1997. United States Vaccine Research: A Delicate Fabric of Public and Private Collaboration. Accessed June 1, 2003. Available at: www.cdc.gov/od/nvpo/delfab.pdf. . 1998. National, State, and Urban Area Vaccination Coverage Levels Among Children Aged 19-35 Months United States, July 19961une 1997. Morbidity and Mortality Weekly Report 47~6~:108-116. .1999a. Influenza and Pneumococcal Vaccination Rates Among Persons with Diabetes Mellitus United States, 1997. Morbidity and Mortality Weekly Report 48~42~:961-967. . l999b. Reasons Reported by Medicare Beneficiaries for Not Receiving Influenza and Pneumococcal Vaccinations. Morbidity and Mortality Weekly Report 48~39~:556-560. . 2000. National, State, and Urban Area Vaccination Coverage Levels Among Children Aged 19-35 Months United States, 1999. Morbidity and Mortality Weekly Report 49~26~:585-589. _. 2001a. Advisory Committee on Immunization Practices (ACIP) Policies and Procedures, (December 28, 2001~. . 2001b. ACIP Votes to Temporarily Revise Recommendations for Pneumococcal Conjugate Vaccine (PCV-7) and Votes to Continue Previously Issued Diphtheria, Tetanus, and Pertussis (DTaP) Recommendations. Accessed December 7, 2003. Available at: http: / / www.cdc.gov/nip /news/shortages/pneumo-and-dtap.htm. . 2002a. National, State, and Urban Area Vaccination Coverage Levels Among Chil- dren Aged 19-35 Months United States, 2001. Morbidity and Mortality Weekly Report 51~3~:664-666. . 2002b. Deaths: Leading Causes for 2000. National Vital Statistics Reports 50~16~. _. 2002c. READII Handout, National Partnership for Immunization Congressional Edu- cation Session Quly 31~. . 2002d. Influenza and Pneumococcal Vaccination Levels Among Persons Aged > 65 Years United States, 2001. Morbidity and Mortality Weekly Report 51~45~:1019-1024. . 2002e. Email from K. Edwards, March 1. (Available from IOM.) _. 2002f. Data from the 2002 National Immunization Survey. Email from A. Bhatt, De- cember 17. (Available from IOM.) .2002g. Data from the 2002 National Immunization Survey. Email from L. Rodewald, November 4. (Available from IOM.) . 2002h. Data from the 2002 National Immunization Survey. Email from P. Smith, June 26. (Available from IOM.)

REFERENCES 213 .2002i. Data from unpublished CDC report. Email from A. Bhatt, December 16. (Avail- able from IOM.) .2002j. Vaccine Development and Testing. Vaccine Fact Sheets. Accessed July 27,2002. Available at: www.cdc.gov/od/nvpo/fs_tableII_docl.htm. .2002k. Vaccine Product Approval Process. Vaccine Fact Sheets. Accessed July 27,2002. Available at: www.cdc.gov/od/nvpo/fs_tableII_doc2.htm. . 20021. Vaccine price data complied by CDC. Emails from R. Ellington between July and September 2002. (Available from IOM.) . 2002m. Email from R. Ellington, July 26. (Available from IOM.) _. 2002n. Comments from D. O'Mara on December 1993 Abt Report Titled: Cost-Effec- tiveness Study of Medicare Coverage of Influenza Vaccine, July. Unpublished. (Avail- able from IOM.) . 2003a. Email from A. Bhatt, June 20, 2003. (Available from IOM.) . 2003b. Estimated Vaccination Coverage With Individual Vaccines and Selected Vaccination Series by 24 Months of Age by Immunization Action Plan Area U.S.A., National Immuniza- tion Survey. Accessed April 16,2003. Available at: http://www.cdc.gov/nip/coverage/ NIS / 98-99 / 24months_urb . xls. . 2003c. Email from A. Bhatt, April 4. (Available from IOM.) __. 2003d. CDC Vaccine Price List. Accessed April 1, 2003. Available at: http:// www.cdc.gov/nip/vfc/cdc_vac_price_list.htm. . 2003e. Recommended Childhood Immunization Schedule, United States, 2002. Accessed March 28, 2003. Available at: http://www.cdc.gov/nip/recs/child-schedule- twopages.pdf. .2003f. Recommended Adult Immunization Schedule, 2002-2003. Accessed March 28,2003. Available at: http: / /www.cdc.gov/nip /recs/adult-schedule. . 2003g. Email from A. Bhatt, July 10. (Available from IOM.) . 2003h. Current Vaccine Delays and Shortages. Accessed March 28, 2003. Available at: http: / /www.cdc.gov/nip/news/shortages/default.htm#Which. Clarke, B.2002. Presentation to Strengthening the Supply of Routinely Recommended Vaccines in the US, the National Vaccine Advisory Committee, Washington, DC (February 11~. Cohen, J. 2002. U.S. Vaccine Supply Falls Seriously Short. Science 295:1998-2001. Cohen, J.W., and P.J. Cunningham. 1995. Medicaid Physician Fee Levels and Children's Access to Care. Health Affairs 14~1~:255-262. Crawford, L. 2002. FDA's Role in Maintaining the Supply of Childhood Vaccines. Testimony Before the Committee on Governmental Affairs, United States Senate June 12~. Darden, P., J. Taylor, and D. Brooks. 1999. Polio Immunization Practices of Pediatricians. Paper Presented Before the Pediatric Academic Societies meeting, San Diego, Califor- nia. Davidson, A., P. Melinkovich, B. Beatty, V. Chandramouli, S. Hambridge, S. Phibbs, P. Braun, C. LeBaron, and J. Steiner. 2003. Immunization Registry Accuracy: Improvement with Progressive Clinical Application. American Journal of Preventive Medicine 24~3~:276-280. Davis, M., J. Zimmerman, R. Wheeler, and G. Freed. 2002. Childhood Vaccine Purchase Costs in the Public Sector: Past Trends, Future Expectations. American Journal of Public Health 92~12~:1982-1986. DeBrock, L., and H. Grabowski. 1985. Economic Aspects of Vaccine Innovation and Manu- facturing. In: Vaccine Supply and Innovation. Institute of Medicine. Pp. 45-64. Washing- ton, DC: National Academy Press. Dickey L., and D. Petitti. 1992. Patient-Held Minirecord to Promote Adult Preventive Care. Journal of Family Practice 34:457463. DiMasi, J., R. Hansen, and H. Grabowski, and L. Lasagna. 1991. Costs of Innovation in the Pharmaceutical Industry. Journal of Health Economics 10~2~:107-142.

214 FINANCING VACCINES IN THE 21ST CENTURY DiMasi, J., R. Hansen, and H. Grabowski. 2003. The Price of Innovation: New Estimates of Drug Development Costs. Journal of Health Economics 22~2~:325-330. Ekwueme, D., P. Strebel, S. Hadler, M. Meltzer, J. Allen, and J. Livengood. 2000. Economic Evaluation of the Use of Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) or Diphtheria, Tetanus, and Whole-Cell Pertussis Vaccine (DTwP) in the United States, 1997. Archives of Pediatric and Adolescent Medicine 154:797-803. Ellis, R., and G. Douglas. 1994. Combination Vaccines. International Journal of Technology As- sessment in Health Care 10~1~:185-192. Fairbrother, G., and A. Haidery. 2002. Vaccine Purchase and Distribution: Proposed Changes in Vaccine Supply and Delivery Policies. Unpublished. (Available from IOM.) Fairbrother, G., S. Friedman, K. Dumont, and K. Lobach. 1996. Markers for Primary Care: Missed Opportunities to Immunize and Screen for Lead and Tuberculosis by Private Physicians Serving Large Numbers of Inner-City Medicaid-Eligible Children. Pediatrics 97~6 Pt 1~:785-790. Fairbrother, G., S. Friedman, K. Hanson, and G. Butts. 1997. Effect of the Vaccines for Chil- dren Program on Inner-City Neighborhood Physicians. Archives of Pediatric and Adoles- cent Medicine 151~12~:1229-1235. Fairbrother, G., K. Hanson, S. Friedman, and G. Butts. 1999. The Impact of Physician Bo- nuses, Enhanced Fees, and Feedback on Childhood Immunization Coverage Rates. American Journal of Public Health 89~2~:171-175. Fairbrother, G., H. Kuttner, W. Miller, R. Hogan, H. McPhillips, K. Johnson, and E. Alexander. 2000. Findings from Case Studies of State and Local Immunization Pro- grams. American Journal of Preventive Medicine 19~3 Supplement):54-77. Federal Funds Information for States. 2002. Growth in Federal Grants for Immunization, Issue Brief 02-58. November 7, 2002. Fee, E., and T. Brown. 2002. The Unfulfilled Promise of Public Health: Deja Vu All Over Again. Health Affairs 21~6~:3143. Feikema, S., R. Klevens, M. Washington, and L. Barker. 2000. Extraimmunization Among U.S. Children. Journal of the American Medical Association 283~10~:1311-1317. Felton, H. 1957. Pertussis: Current Status of Prevention and Treatment. Pediatric Clinics of North America 31:271-283. Fielding, J., W. Cumberland, and L. Pettitt. 1994. Immunization Status of Children of Em- ployers in a Large Corporation. Journal of the American Medical Association 271:525-530. Fine, A. 2003. Diphtheria, Tetanus and Acellular Pertussis Vaccine (DTaP): A Case Study. Unpub- lished. (Available from IOM.) Finkelstein, A. 2003. Health Policy and Technological Change: Evidencefrom the Vaccine Industry. Working Paper 9460. Cambridge, MA: National Bureau of Economic Research. Fontanesi, J., M. DeGuire, M. Holcomb, and M. Sawyer. 2001. The Cost to Immunize During Well-Child Visits. American Journal of Medical Quality 16~6~:196-201. Food and Drug Administration (FDA). 2003. Product Approval Letter to MedImmune Vaccines, Inc., dated June 17, 2003. Accessed July 10, 2003. Available at: http://www.fda.gov/ cber/approvltr/inflmedO61703L.htm. . 2002. New Pediatric Combination Vaccine Approved. FDA Talk Paper. Accessed Decem- ber 16, 2002. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2002/ ANSO1181.html. Foulkes, M., and S. Ellenberg. 2002. Vaccine Efficacy and Safety Evaluation. In: National Insti- tutes of Health. The Jordan Report. France, E. 2000. Vaccine Financing: The View of Managed Care. American Journal of Preven- tive Medicine 19~3 Supplement):23-25. Freed, G., and A. Cowan. 2002. State-Level Perspectives on Vaccine Purchase Financing. Decem- ber 2002. Unpublished. (Available from IOM.)

REFERENCES 215 Freed, G., S. Clark, D. Pathman, R. Schectman, and J. Serling. 1999. Impact of North Caro- lina's Universal Vaccine Purchase Program by Children's Insurance Status. Archives of Pediatric and Adolescent Medicine 153:748-754. Freed, G., S. Clark, and A. Cowan. 2000. State-Level Perspectives on Immunization Policies, Practices, and Program Financing in the 1990s. American Journal of Preventive Medicine 19~3 Supplement):32-44. Freed, G., M. Davis, M. Andreae, S. Bass, and H. Weinblatt. 2002a. Reimbursement for Prevnar: A Modern-Day Version of Hercules and the Hydra. Pediatrics 110~2 Pt 1~:399- 400. Freed, G., M. Andreae, A. Cowan, and S. Katz. 2002b. The Process of Public Policy Formula- tion: The Case of Thimerosal in Vaccines. Pediatrics 109~6~:1153-1159. Freeman, P., and A. Robbins. 1991. The Elusive Promise of Vaccines. The American Prospect 93. Gabel, J., A. Sasso, and T. Rice. 2002. Consumer-Driven Health Plans: Are They More Than Talk Now? Health Affairs 21~1~:W395-W407. Gangarosa, E., A. Galazka, C. Wolfe, L. Phillips, R. Gangarosa, E. Miller, and R. Chen. 1998. Impact of Anti-Vaccine Movements on Pertussis Control: The Untold Story. The Lancet 351:356-361. General Accounting Office. 1995. Reexamination of Program Goals and Implementation Needed to Ensure Vaccination. Washington, DC: U.S. General Accounting Office. . 2001. Health Centers and Rural Health Clinics: Payments Likely to Be Constrained Under Medicaid's New System. Washington, DC: U.S. General Accounting Office June). . 2002. Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges. 2002. Washington, DC: U.S. General Accounting Office. GlaxoSmithKline. 2002. Letter to the U.S. General Accounting Office (April 30~. Glazner, J., J. Steiner, K. Haas, B. Renfrew, M. Deutchman, and S. Berman. 2001. Is Reim- bursement for Childhood Immunizations Adequate? Evidence from Two Rural Areas in Colorado. Public Health Reports 116~3~:219-225. Glode, M. 2001. Combination vaccines: Practical Considerations for Public Health and Pri- vate Practice. Pediatric Infectious Disease Journal 20~11~:Sl9-S22 (November). Gold, M., L. Russet, J. Siegel, and M. Weinstein (eds.~. 1996. Cost-Effectiveness in Health and Medicine. Oxford: Oxford University Press. Grabowski, H., and J. Vernon. 1997. The Search for New Vaccines: The Effects of the Vaccines for Children Program. Washington, DC: AEI Press. Grabowski, H., and J. Vernon. 2000. The distribution of Sales Revenue from Pharmaceutical Innovation. PharmacoEconomics 18(Supplement 1~:21-32. Hay, J., and D. Zammit. 2002. Vaccine Policy Perspectives: Market Strategies. Unpublished. (Available from IOM.) Hirschler, B. 2002. Vaccine Renaissance Outpaces Sickly Drug Industry. Reuters News Ser- vice, December 5, 2002. Home, P., K. Saarlas, and A. Hinman. 2000. Costs of Immunization Registries: Experiences From the All Kids Count Projects. American Journal of Preventive Medicine 19~2~:94-98. Hughart, N., D. Strobino, E. Holt, B. Guyer, W. Hou, A. Huq, and A. Ross. 1999. The Relation of Parent and Provider Characteristics to Vaccination Status of Children in Private Prac- tices and Managed Care Organizations in Maryland. Medical Care 37~1~:44-55. Huse, D., H. Meissner, M. Lacey, and G. Oster. 1994. Childhood Vaccination Against Chickenpox and Analysis of Benefits and Costs. Journal of Pediatrics 124:869-874. Institute of Medicine. 1985. Vaccine Supply and Innovation. Washington, DC: National Acad- emy Press. . 1993. The Children's Vaccine Initiative. Washington, DC: National Academy Press.

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The national immunization system has achieved high levels of immunization, particularly for children. However, this system faces difficult challenges for the future. Significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations. These disparities result, in part, from fragmented public–private financing in which a large number of children and adults face limited access to immunization services. Access for adults lags well behind that of children, and rates of immunizations for those who are especially vulnerable because of chronic health conditions such as diabetes or heart and lung disease, remain low.

Financing Vaccines in the 21st Century: Assuring Access and Availability addresses these challenges by proposing new strategies for assuring access to vaccines and sustaining the supply of current and future vaccines. The book recommends changes to the Advisory Committee on Immunization Practices (ACIP)-the entity that currently recommends vaccines-and calls for a series of public meetings, a post-implementation evaluation study, and development of a research agenda to facilitate implementation of the plan.

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