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Homeland Security


U.S. Policy Regarding Pandemic-Influenza Vaccines

References

References

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Danzon, Patricia M., Nuno Sousa Pereira, and Sapna S. Tejwani. 2005. "Vaccine Supply: A Cross-National Perspective." Health Affairs, vol. 24, no. 3, pp. 712–715.

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DiMasi, Joseph A., Ronald W. Hansen, and Henry G. Grabowski. 2003. "The Price of Innovation: New Estimates of Drug Development Costs." Journal of Health Economics, vol. 22, no. 2, pp. 151–185.

Donaldson, Liam. 2006. "Global Health Strategies for Global Health Threats." Department of Health (U.K.), Wood Memorial Lecture for the Royal Naval Dental Services, Fort Blockhouse, Gosport, Hants. June 30.

Ehrlich, Hartmut J., and others. 2008. "A Clinical Trial of a Whole-Virus H5N1 Vaccine Derived from Cell Culture." New England Journal of Medicine, vol. 358, no. 24, pp. 2573–2584.

European Commission. 2007. Influenza Research: EU Funded Projects 20012007. EUR22822. Brussels: European Commission, Directorate-General for Research. http://ec.europa.eu/research/health/poverty-diseases/doc/influenza-research_en.pdf.

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——. 2007b. "European Public Assessment Report (EPAR): Focetria, EPAR Summary for the Public." May. www.emea.europa.eu/humandocs/PDFs/EPAR/focetria/H-710-en1.pdf.

——. 2008. "European Public Assessment Report (EPAR): Prepandrix, EPAR Summary for the Public." March. www.emea.europa.eu/humandocs/PDFs/EPAR/prepandrix/H-822-en1.pdf.

FDA (Food and Drug Administration). 2006. "FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus." Press release. June 8. www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html.

——. 2007. "FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1." Press release. April 17; updated April 19. www.fda.gov/bbs/topics/NEWS/2007/NEW01611.html.

Fedson, David S. 2003. "Pandemic Influenza and the Global Vaccine Supply." Clinical Infectious Diseases, vol. 36, no. 12, pp. 1552–1561.

Ferguson, Neil M., and others. 2006. "Strategies for Mitigating an Influenza Pandemic." Nature (London), vol. 422, no. 7101, p. 448.

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Government Accountability Office. 2007. Influenza Vaccine: Issues Related to Production, Distribution, and Public Health Messages. Report to the Committee on Oversight and Government Reform, House of Representatives. GAO-08-27.

Gray, Alistair. 2008. "Trial Results Give Acambis Boost in Race for Pandemic Flu Vaccine." Financial Times. January 4. www.ft.com/cms/s/0/c72ba9ea-ba67-d1dc-abcb-0000779fd2ac.html?nclick_check=1.

GSK (GlaxoSmithKline). 2007. "GlaxoSmithKline Files its New Pre-Pandemic Influenza Vaccine in Europe." Press release. January 29. www.gsk.com/media/pressreleases/2007/2007_01_29_GSK961.htm.

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HHS (Department of Health and Human Services). 2005a. "HHS Awards $97 Million Contract to Develop Cell Culture-Based Influenza Vaccine: Effort Designed to Diversify and Accelerate Vaccine Production to Enhance Pandemic Preparedness." Press release. April 1. www.hhs.gov/news/press/2005pres/20050401.html.

——. 2005b. HHS Pandemic Influenza Plan. www.hhs.gov/pandemicflu/plan/pdf/HHSPandemicInfluenzaPlan.pdf.

——. 2006a. "Adapting Manufacturing Facilities for Production of Pandemic Influenza Vaccines." Request for proposal. DHHS-ORDC-VB-06-07. July 24.

——. 2006b. "HHS Awards Contracts Totaling More Than $1 Billion to Develop Cell-Based Influenza Vaccine." Press release. May 4. www.hhs.gov/news/press/2006pres/20060504.html.

——. 2006c. HHS Pandemic Planning Update II: A Report from Secretary Michael O. Leavitt. June 29.

——. 2007. "HHS Funds Advanced Development of H5N1 Influenza Vaccines: Three New Contracts Will Focus on Antigen-Sparing Vaccines." Press release. January 17. www.hhs.gov/news/press/2007pres/01/20070117b.html.

Homeland Security Council. 2006. National Strategy for Pandemic Influenza. May. www.whitehouse.gov/homeland/nspi_implementation.pdf.

Institute of Medicine. 2004. Financing Vaccines in the 21st Century. Report of the Board on Health Care, Committee on the Evaluation of Vaccine Purchase Financing in the United States. Washington, D.C.: National Academy Press.

Iomai. 2008a. "Iomai Receives HHS Approval to Begin Phase 2 Trial of H5N1 Influenza Adjuvant Patch." Press release. April 15. http://investors.iomai.com/phoenix.zhtml?c=178326&p=irol-newsArticle&ID=1129568&highlight.

——. 2008b. "Study Finds Single Dose of Iomai Patch with Pandemic Flu Vaccine Achieves Protective Levels." Press release. March 20. http://investors.iomai.com/phoenix.zhtml?c=178326&p=irol-newsArticle&ID=1120501&highlight.

Kenney, Richard, and Robert Edelman. 2004. "Adjuvants for the Future." In New Generation Vaccines, 3rd ed. Myron Levine and others, eds. New York: Marcel Dekker.

Kolata, Gina. 1999. Flu: The Story of the Great Influenza Pandemic of 1918 and the Search for the Virus That Caused It. New York: Farrar, Straus, and Giroux.

Lash, Lyle, III, and Henry Wang. 2006. "Economic Comparison of Egg and Cell Culture for Influenza Vaccine Manufacturing." Presentation. American Chemical Society annual meeting, Division of Biochemical Technology. San Francisco. September 14.

Lewcock, Anna. 2007a. "Cell-Based Flu Jab Gets EU Go Ahead." In-PharmaTechnologist.com. June 13.www.in-pharmatechnologist.com/news/ng.asp?n=77338&m=1IPE613&c=fvaksanwurcxpyl.

——. 2007b. "First US Cell-Based Flu Vaccine Plant Underway." In-PharmaTechnologist.com. August 28. www.in-pharmatechnologist.com/news/ng.asp?n=79288_novartis-vaccine-cell-based.

——. 2007c. "Low Dose Bird Flu Shot Promises Pandemic Protection." Outsourcing-Pharma.com. September 18. www.outsourcing-pharma.com/news/ng.asp?n=79839&m=1OSP918&c=fvaksanwurcxpyl.

——. 2007d. "Manufacturers Back WHO Avian Flu Stockpiling Plans." In-PharmaTechnologist.com. June 14. www.in-pharmatechnologist.com/news/ng.asp?n=77381&m=1IPE614&c=fvaksanwurcxpyl.

Lister, Sarah. 2007. Pandemic Influenza: Domestic Preparedness Efforts. CRS Report for Congress RL33145. Congressional Research Service. February 20.

Mackenzie, Deborah. 2005. "Stockpile Bird Flu Vaccine Now." New Scientist Online. February 17. www.newscientist.com/channel/health/bird-flu/dn7012.

Matthews, James. 2006. "Egg-Based Influenza Vaccine Production—30 Years of Commercial Experience and Our Future Expectations for Cell Culture." Presentation. National Academy of Engineering and Institute of Medicine conference, Vaccine Production Engineering Approaches to a Pandemic. Washington, D.C. April 10–11.

McKenna, Maryn. 2007a. "The Pandemic Vaccine Puzzle." CIDRAP News. University of Minnesota, Center for Infectious Disease Research and Policy. October–November. www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/nov1507panvax.html.

——. 2007b. "The Pandemic Vaccine Puzzle; Part 4: The Promise and Problems of Adjuvants." CIDRAP News. University of Minnesota, Center for Infectious Disease Research and Policy. October 30. www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/oct3007panvax4.html.

Megget, Katrina. 2007. "GSK Increases H5N1 Vaccine Presence in US." In-PharmaTechnologist.com. August 7. www.in-pharmatechnologist.com/news/ng.asp?id=78815.

Mercer Management Consulting. 2002. Lessons Learned: New Procurement Strategies for Vaccines. Final Report to the GAVI Board. Geneva, Switzerland: GAVI Alliance Secretariat. June 28.

Mounier-Jack, Sandra, Ria Jas, and Richard Coker. 2007. "Progress and Shortcomings in European National Strategic Plans for Pandemic Influenza." Bulletin of the World Health Organization, vol. 85, no. 12, pp. 923–929.

Mutsch, Margot, and others. 2004. "Use of the Inactivated Intranasal Influenza Vaccine and the Risk of Bell’s Palsy in Switzerland." New England Journal of Medicine, vol. 350, no. 9, pp. 896–903.

NIH (National Institutes of Health). 2008a. "Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok." ClinicalTrials.gov. http://ClinicalTrials.gov/show/NCT00539981.

——. 2008b. "Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged 18 Years and 49 Years." ClinicalTrials.gov.http://clinicaltrials.gov/show/nct00599443.

——. 2008c. "Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine." ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT00664417.

Novartis. 2007. Annual Report. Basel, Switzerland.

Osterholm, Michael, and Helen Branswell. 2005. "Emerging Pandemic: Costs and Consequences of an Avian Influenza Outbreak." Presentation. Woodrow Wilson International Center for Scholars. September 19. www.wilsoncenter.org/index.cfm?event_id=142787&fuseaction=events.event_summary.

Pink Sheet. 2007. "Novartis Vaccines Unit Looks to Make Its Presence With New Technologies." Prescription Pharmaceuticals and Biotechnology, vol. 69, no. 48 (November 26), p. 27.

Poland, Gregory A. 2006. "Vaccines Against Avian Influenza—A Race Against Time." New England Journal of Medicine, vol. 354, no. 13, pp. 1411–1413.

Program for Appropriate Technology in Health. 2007. Influenza Vaccine Strategies for Broad Global Access: Key Findings and Project Methodology. October. www.path.org/files/VAC_infl_publ_rpt_10-07.pdf.

Raymond, Emilie. 2006. "Baxter Signs Austrian Flu Vaccine Contract." DrugResearcher.com. November 23. www.drugresearcher.com/news/ng.asp?n=72275-baxter-austria-influenza.

Robinson, Robin. 2007. "U.S. Pandemic Preparedness Medical Countermeasures: Forecasts for Development, Stockpiling, and Infrastructure Building." Presentation. HHS Public Health Emergency Med-ical Countermeasures Enterprise Stakeholders Workshop. Washington, D.C. August 2. www.medicalcountermeasures.gov/video_content/day3.html.

——. 2008. "U.S. Government Progress on Next Generation Medical Countermeasures for Pandemic Influenza." Presentation. Phacilitate Vaccine Forum, Focus Session 1. Washington, D.C. January 28.

Sanofi Pasteur. 2006. "Sanofi Pasteur Supplies Prototype Vaccine for Italian Government Pandemic Initiatives." Press release. February 28. www.sanofipasteur.com/sanofi-pasteur/front/index.jsp?siteCode=AVPI_US&codeRubrique=80&codePage=PressRelease_15_12_2005_3.

——. 2007a. "FDA Licenses First U.S. Vaccine for Humans Against Avian Influenza." Press release. April 17. http://en.sanofi-aventis.com/Images/20070417_h5n1_fda_en_tcm24-17270.pdf.

——. 2007b. "Sanofi Pasteur Initiates Phase II Trial of Cell Culture-Based Seasonal Influenza Vaccine." Press release. November 7. http://198.73.159.214/sanofi-pasteur/ImageServlet?imageCode=20613&siteCode=SP_HQ.

——. 2007c. "Sanofi Pasteur’s Investigational H5N1 Influenza Vaccine Achieves High Immune Response at Low Dosage." Press release. September 18. www.sanofipasteur.com/sanofi-pasteur/front/index.jsp?codeRubrique=131&lang=EN&siteCode=SP_HQ.

Struck, Mark-M. 1996. "Vaccine R&D Success Rates and Development Times." Nature Biotechnology,vol. 14, pp. 591–593.

Taylor, Nick. 2008a. "Microbix Chinese Vaccine Plant Boosts Global Capacity by 20%." In-PharmaTechnologist.com. June 25. www.in-pharmatechnologist.com//news/ng.asp?n=86126&c=0D7Cw4Nu12o0Ujt0QSIq3g%3D%3D.

——. 2008b. "Sanofi Launches $6.25bn Vaccine Battle Plan." In-PharmaTechnologist.com. June 26. www.in-pharmatechnologist.com/news/ng.asp?id=86156-sanofi-aventis-vaccine-plant.

Taylor, Phil. 2007. "WHO to Help Fund Bird Flu Vaccine Plants in Developing World." In-PharmaTechnologist.com. April 26. www.in-pharmatechnologist.com/news/ng.asp?n=76070-who-bird-flu-vaccine.

Vaccine Weekly. 2007. "Flu Vaccines; Sanofi Pasteur Announces Completion of Construction of New U.S. Influenza Vaccine Manufacturing Facility." August 8, p. 16.

Vogel, Frederick, and Stanley Hem. 2004. "Immunologic Adjuvants." In Vaccines, 4th ed. Stanley A. Plotkin and Walter A. Orenstein, eds., with assistance of Paul A. Offit. Philadelphia: Saunders, pp. 69–79.

Whalen, Jeanne. 2006. "Novartis Plans North Carolina Flu-Vaccine Facility." Wall Street Journal. July 19, p. D13.

——. 2008a. "European Regulators Back Bird-Flu Vaccine." Wall Street Journal. February 22, p. B4.

——. 2008b. "Sanofi Sees Global Vaccine Sales Doubling." Wall Street Journal. June 26, p. B5.

WHO (World Health Organization). 2006. Global Pandemic Influenza Action Plan to Increase Vaccine Supply. www.who.int/vaccines-documents/DocsPDF06/863.pdf.

—. 2007a. "Epidemic and Pandemic Alert and Response, Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO." June 19. www.who.int/csr/disease/avian_influenza/en/.

——. 2007b. "Global Stockpile of H5N1 Vaccine 'Feasible.’" Press release. April 26. www.who.int/mediacentre/news/releases/2007/pr21/en/index.html.

——. 2007c. "Initiative for Vaccine Research (IVR): Tables on the Clinical Trials of Pandemic Influenza Prototype Vaccines, Complete Data Set." July 19. www.who.int/vaccine_research/diseases/influenza/flu_trials_tables/en/index3.html.

——. 2007d. "Projected Supply of Pandemic Influenza Vaccine Sharply Increases." Press release. October 23. www.who.int/mediacentre/news/releases/2007/pr60/en/index.html.

——. 2008. 4th WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials. Geneva, Switzerland. February 1415. www.who.int/vaccine_research/diseases/influenza/meeting_140208/en/print.html.

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Wright, Peter F. 2008. "Vaccine Preparedness—Are We Ready for the Next Influenza Pandemic?" New England Journal of Medicine, vol. 358, no. 24, pp. 2540–2543.


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