Vaccine supply, demand, and policy: A primer
Jagannath M. Muzumdar, MS; Richard R. Cline, PhD
J Am Pharm Assoc (2003) 2009;49:e87-e99. doi:10.1331/JAPhA.2009.09007


Objective  To provide an overview of supply and demand issues in the vaccine industry and the policy options that have been implemented to resolve these issues.

Data sources  Medline, Policy File, and International Pharmaceutical Abstracts were searched to locate academic journal articles. Other sources reviewed included texts on the topics of vaccine history and policy, government agency reports, and reports from independent think tanks. Keywords included vaccines, immunizations, supply, demand, and policy.

Study selection  Search criteria were limited to English language and human studies. Articles pertaining to vaccine demand, supply, and public policy were selected and reviewed for inclusion.

Data extraction  By the authors.

Data synthesis  Vaccines are biologic medications, therefore making their development and production more difficult and costly compared with “small-molecule” drugs. Research and development costs for vaccines can exceed $800 million, and development may require 10 years or more. Strict manufacturing regulations and facility upgrades add to these costs. Policy options to increase and stabilize the supply of vaccines include those aimed at increasing supply, such as government subsidies for basic vaccine research, liability protection for manufacturers, and fast-track approval for new vaccines. Options to increase vaccine demand include advance purchase commitments, government stockpiles, and government financing for select populations.

Conclusion  High development costs and multiple barriers to entry have led to a decline in the number of vaccine manufacturers. Although a number of vaccine policies have met with mixed success in increasing the supply of and demand for vaccines, a variety of concerns remain, including developing vaccines for complex pathogens and increasing immunization rates with available vaccines. New policy innovations such as advance market commitments and Medicare Part D vaccine coverage have been implemented and may aid in resolving some of the problems in the vaccine industry.


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Orenstein WA, Douglas RG, Rodewald LE, Hinman AR. Immunizations in the United States: success, structure, and stress Health Aff. 2005;24:599–610.[CrossRef]
Salinsky E, Werble C. The vaccine industry: does it need a shot in the arm? National Health Policy Forum. Washington, DC:  George Washington University;  2006:1–34.
Arthur A. Vaccines: the controversial story of medicine's greatest lifesaver. Part II. New York, W.W. Norton & Company;  2007:12, 27.
Ulmer JB, Valley U, Rappuoli R. Vaccine manufacturing: challenges and solutions Nat Biotechnol. 2006; 24:1377–83.[PubMed]
Zhou F, Santoli J, Messonnier ML, et al. Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001 Arch Pediatr Adolesc Med. 2005;159:1136–44.[PubMed]
Salo H, Kilpi T, Sintonen H, et al. Cost-effectiveness of influenza vaccination of healthy children Vaccine. 2006;24:4934–41.[PubMed]
Paul Y. Herd immunity and herd protection Vaccine. 2004;22:301–2.[PubMed]
Ritvo P, Wilson K, Willms D, Upshur R. Vaccines in the public eye Nat Med. 2005;11(4 suppl):S20–4.[PubMed]
Bloom D, Canning D, Malaney P. Demographic change and economic growth in East Asia Popul Dev Rev. 2000;26:257–90.
Bloom D, Canning D. The health and wealth of nations Science. 2000;(Feb 18):1207–9.
Andre FE, Booy R, Bock HL, et al. Vaccination greatly reduces disease, disability, death and inequity worldwide Bull World Health Organ. 2008;86:140–6.[PubMed]
Nordhaus W. The health of nations: the contribution of improved health to living standards In: Murphy KH, Topel RH, Eds.  Measuring the gains from medical research: an economic approach. Chicago:  University of Chicago Press;  2003.
 Centers for Disease Control and Prevention. Impact of vaccines universally recommended for children: United States, 1990–1998 MMWR Morb Mortal Wkly Rep. 1999;48(12):243–8.[PubMed]
Bridges CB, Thompson WW, Meltzer MI, et al. Effectiveness and cost-benefit of influenza vaccination of healthy working adults: a randomized control trial JAMA. 2000;284:908–13.
Demicheli V, Rivetti D, Deeks JJ, Jefferson TO. Vaccines for preventing influenza in healthy adults Cochrane Database Syst Rev. 2004;CD001269.
Iglehart J. Financing vaccines: in search of solutions that work Health Aff. 2005;24:594–5.
Calfee JE, Gottlieb S. Putting markets to work in vaccine manufacturing Accessed at www.aei.org/publications/pubID.21659/pub_detail.asp, October 22,  2007.
Offit P. Why are pharmaceutical companies gradually abandoning vaccines? Health Aff. 2005;24:622–30.
 Centers for Disease Control and Prevention. Vaccines & immunizations: 2002 immunization news Accessed at www.cdc.gov/vaccines/news/news-pubs/news2002.htm, December 04,  2007.
 National Vaccine Advisory Committee. Strengthening the supply of routinely recommended vaccines in the United States: recommendations from the National Vaccine Advisory Committee JAMA. 2003;290:3122–8.[PubMed]
 American Academy of Pediatrics. Red Book online: special alert: Hib shortage Accessed at http://aapredbook.aappublications.org/news, January 5,  2008.
Hinman AR, Orenstein WA, Santoli JM, et al. Vaccine shortages: history, impact, and prospects for the future Annu Rev Public Health. 2006;27:235–59.[PubMed]
 Reuters Health Information. Tropical Dengue fever may threaten U.S.: report Accessed at www.reuters.com/article/bondsNews/idUSN0847856420080108, January 10,  2008.
Thwing J, Skarbinski J, Newman RD, et al. Malaria surveillance: United States, 2005 MMWR Surveill Summ. 2007;56(6):23–40.[PubMed]
 Centers for Disease Control and Prevention. Measles: United States, January 1–April 25, 2008 Accessed at www.cdc.gov/mmwr/preview/mmwrhtml/mm5718a5.htm, June 8,  2008.
Donnelly CA, Fischer MC, Fraser C, et al. Epidemiological and genetic analysis of severe acute respiratory syndrome Lancet Infect Dis. 2004;4:672–83.[PubMed]
 Food and Drug Administration. Just the facts: vaccines provide effective protection and FDA makes sure they are safe Accessed at www.fda.gov/opacom/factsheets/justthefacts/19vaccine.html, November 22,  2007.
Thaul S. CRS report for Congress: vaccine policy issues Accessed at www.fas.org/sgp/crs/misc/RL31793.pdf, November 30,  2007.
Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhea in the United States: surveillance and estimates of disease burden J Infect Dis. 1996;174(1 suppl):S5–11.
 Food and Drug Administration, Center for Biologics Evaluation and Research. Vaccine product approval process: 2002 Accessed at www.fda.gov/Cber/vaccine/vacappr.htm, November 12,  2007.
Plotkin S, Orenstein W, Offit P. Vaccines.5th ed. Toronto, Canada:  Elsevier;  2008:37, 39.
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs J Health Econ. 2003;22:151–85.[PubMed]
Sloan F, Berman S, Rosenbaum S, et al. The fragility of the US vaccine supply N Engl J Med. 2004;351:2443–7.[PubMed]
Dooren JC. Merck recalls childhood vaccine Accessed at http://online.wsj.com/article/SB119749483569624501.html, December 20,  2007.
 Institute of Medicine. Financing vaccines in the 21st century.1st ed., chapters 1 and 3. Washington, DC:  National Academies Press;  2003.
 Mercer Management Consulting. Lessons learned: new procurement strategies for vaccines: final report to the GAVI Board. New York:  Mercer Management Consulting;  2002.
Thompson WW, Price C, Goodson B, et al. Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years N Engl J Med. 2007;357:1281–92.[PubMed]
Tozzi AE, Bisiacchi P, Tarantino V, et al. Neuropsychological performance 10 years after immunization in infancy with thimerosal-containing vaccines Pediatrics. 2009;123:475–82.[PubMed]
Offit P. Autism‘s false prophets: bad science, risky medicine, and the search for a cure.1st ed. New York:  Columbia University Press;  2008.
 Centers for Disease Control and Prevention. Withdrawal of rotavirus vaccine recommendation Accessed at www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm, November 23,  2007.
Hinman AR, Orenstein WA, Rodewald L. Financing immunizations in the United States Clin Infect Dis. 2004;38:1440–6.[PubMed]
Hinman AR, Orenstein WA, Santoli JM, et al. Vaccine shortages: history, impact, and prospects for the future Annu Rev Public Health. 2006;27:235–59.[PubMed]
 Centers for Disease Control and Prevention. National, state, and local area vaccination coverage among children aged 19–35 months: United States, 2007 MMWR Morb Mortal Wkly Rep. 2008;57:961–6.[PubMed]
Corrigan J. New data show unacceptably low adult immunization rates and that adults unaware of infectious disease threat Accessed at www.reuters.com/article/pressRelease/idUS181452+23-Jan-2008+PRN20080123, May 30,  2009.
King DA, Peckham C, Waage JK. Epidemiology: infectious diseases: preparing for the future Science. 2006;313:1392–3.[PubMed]
Lee GM, Santoli J, Hannan C, et al. Gaps in vaccine financing for underinsured children in the United States JAMA. 2007;298:638–43.[PubMed]
Coleman M, Fontanesi J, Meltzer MI, et al. Estimating medical practice expenses from administering adult influenza vaccinations Vaccine. 2005;23:915–23.[PubMed]
Freed GL, Cowan AE, Clark SJ. Primary care physician perspectives on reimbursement for childhood immunizations Pediatrics.  2008;122:2008–33.
Benin AL, Wisler-Scher DJ, Colson E, et al. Qualitative analysis of mothers’ decision-making about vaccines for infants: the importance of trust Pediatrics. 2006;117:1532–41.[PubMed]
Kennedy AM, Brown CJ, Gust DA. Vaccine beliefs of parents who oppose compulsory vaccination Public Health Rep. 2005;120:252–8.[PubMed]
Gust DA, Darling N, Kennedy A, Schwartz B. Parents with doubts about vaccines: which vaccines and reasons why Pediatrics. 2008;122:718–25.[PubMed]
Boardman AE, Greenberg DH, Vining AR, Weimer DL. Cost-benefit analysis: concepts and practice. Upper Saddle River, NJ:  Prentice Hall;  1996(appendix 3B):99–110.
Gottron F. CRS report for Congress: RS21507 Project Bioshield Accessed at www.au.af.mil/au/awc/awcgate/crs/rs21507.pdf, December 27,  2007.
 Food and Drug Administration. Project Bioshield: protecting Americans from terrorism Accessed at www.fda.gov/fdac/features/2004/604_terror.html, August 2,  2008.
 U.S. Department of Health and Human Services. Pandemic and All-Hazard Preparedness Act Accessed at www.hhs.gov/aspr/opsp/pahpa/index.html, May 29,  2009.
 Food and Drug Administration. Guidance for industry, fast track drug development programs: designation, development, and application review Accessed at www.fda.gov/cber/gdlns/fsttrk.pdf, November 25,  2007.
Hendrickson D. Biovest moves to Fast Track with cancer vaccine Accessed at www.masshightech.com/stories/2006/05/22/story11-Biovest-moves-to-Fast-Track-with-cancer-vaccine.html, August 2,  2008.
 Frederick. FDA grants “fast track” designation for the development of OncoVAX. July 2006 Accessed at www.vaccinogeninc.com/news_0706.cfmAugust 08,  2008.
 U.S. Government Printing Office. 21 CFR 601 subpart E: accelerated approval of biological products for serious or life-threatening illnesses Accessed at http://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr601.40.pdf, November 24,  2007.
 Food and Drug Administration. CFR - Code of Federal Regulations Title 21 Accessed at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601&showFR=1&subpartNode=21:, November 24,  2007.
Gelb L. FDA approves new influenza vaccine for upcoming flu season Accessed at www.fda.gov/bbs/topics/news/2005/NEW01227.html, July 18,  2008.
 Food and Drug Administration. Fast track, priority review and accelerated approval Accessed at www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm, December 7,  2007.
 Food and Drug Administration. FDA licenses new vaccine for prevention of cervical cancer and other diseases in females caused by human papillomavirus Accessed at www.fda.gov/bbs/topics/news/2006/new01385.html, July 31,  2008.
 U.S. Department of Health and Human Services, Health Resources and Services Administration. National Vaccine Injury Compensation Program (VICP) Accessed at www.hrsa.gov/vaccinecompensation, November 26,  2007.
Cohen H. CRS report for Congress: RL31649, Homeland Security Act of 2002: tort liability provisions Accessed at www.policyarchive.org/bitstream/handle/10207/1557/RL31649_20050923.pdf?sequence=1, November 30,  2007.
Thaul S. CRS report for Congress: RL31960, smallpox vaccine injury compensation Accessed at http://biotech.law.lsu.edu/blaw/bt/smallpox/Congress/RL31960.pdf, November 30,  2007.
 U.S. Department of Health and Human Services. Public Readiness and Emergency Preparedness Act questions and answers Accessed at www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html, March 12,  2009.
 GAVI Alliance Accessed at www.gavialliance.org, January 10,  2008.
Batson A. The problems and promise of vaccine markets in developing countries Health Aff. 2005;24:690–3.
 U.S. Department of Health and Human Services. CDC efforts in implementing a smallpox vaccination program Accessed at www.hhs.gov/asl/testify/t030129.html, January 10,  2008.
 Gillis J. U.S. builds stockpile of vaccine for flu pandemic Accessed at www.washingtonpost.com/wp-dyn/content/article/2005/11/29/AR2005112901849.html, June 23,  2008.
Timiraos N. Why a market-driven vaccine plan faces big obstacles Accessed at http://online.wsj.com/public/article_print/SB119906129300958545.html, January 10,  2008.
Maclnnis L. Vaccine bonds provide model for other aid projects Accessed at www.medscape.com/viewarticle/573432, April 30,  2008.
 GAVI Alliance. GAVI Alliance announces dramatic funding boost for Hib vaccine Accessed at www.gavialliance.org/media_centre/press_releases/2007_11_29_en_pr_hib_boost.php, August 11,  2008.
Lindley MC, Orenstein WA, Shen AK, et al. Assuring vaccination of children and adolescents without financial barriers: recommendations from the National Vaccine Advisory Committee (NVAC). Washington, DC:  U.S. Department of Health and Human Services;  2009.
Atkinson WL, Hadler SC, Redd SB, Orenstein WA. Measles surveillance: United States, 1991 MMWR CDC Surveill Summ. 1992;41:1–12.[PubMed]
 Centers for Disease Control and Prevention. Vaccines & immunizations: Vaccines for Children Program (VFC) Accessed at www.cdc.gov/vaccines/programs/vfc, June 12,  2008.
 Centers for Disease Control and Prevention. Childhood vaccine supply policy 2007 Accessed at www.cdc.gov/vaccines/programs/vfc/projects/data/vacc-supply-public-2007.htm, May 29,  2009.
Freed GL, Clark SJ, Pathman DE, et al. Impact of North Carolina's universal vaccine purchase program by children insurance status Arch Pediatr Adolesc Med. 1999;153:748–54.[PubMed]
 Centers for Medicare and Medicaid Services. Adult immunization Accessed at www.cms.hhs.gov/adultImmunizations, June 25,  2008.
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