THE PANDEMIC VACCINE PUZZLE Bibliography

Editor's note: This is the bibliography to a seven-part series launched October 25, 2007, investigating the prospects for development of vaccines to head off the threat of an influenza pandemic posed by the H5N1 avian influenza virus. The series puts advances in vaccine technology in perspective by illuminating the formidable barriers to producing an effective and widely usable vaccine in a short time frame.

Acambis PLC. Acambis' universal influenza vaccine enters phase 1 trial. Jul 17, 2007

BD. Author interview with George Goldman, Senior Director, Hypodermic Divison, BD Medical Surgical Systems. Jul 25, 2007

Belshe RB, Edwards KM, Vesikari T, et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med 2007 Feb 15;256(7):685-96 [Abstract]

Belshe RB, Nichol KL, Black SB, et al. Safety, efficacy, and effectiveness of live, attenuated, cold-adapted influenza vaccine in an indicated population aged 5-49 years. Clin Infect Dis 2004 Oct 1;39(7):920-7 [Full text]

Bosch Technologies. Author interview with Eric Isberg, Jack Lysfjord, and Tony Miller. Aug 3, 2007

Bresson JL, Perrone C, Launay O, et al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006 May 20;367(9523):1657-64 [Abstract]

CDC. Isolation of avian influenza A(H5N1) viruses from humans—Hong Kong. May-December 1997. MMWR 1997 Dec 19;46(50):1204-7 [Full text]

CDC. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2005 Jul 29;54(RR08):1-40 [Full text]

CDC. State-specific influenza vaccination coverage among adults aged >/= 18 years—United States, 2003-04 and 2005-06 influenza seasons. MMWR 2007 Sep 21;56(37):953-9 [Full text]

Crosby AW. America's forgotten pandemic: the influenza of 1918. Cambridge [England]; New York, Cambridge University Press, 1989

ECDC (European Centre for Disease Prevention and Control). 'Pre-pandemic' vaccines might offer protection but uncertainties remain. Sep 20, 2007 [Press release]

ECDC. Technical report: Expert advisory groups on human H5N1 vaccines: scientific questions. Aug 2007 [Full text]

EMEA (European Medicines Agency). Guideline on adjuvants in vaccines for human use. Jan 20, 2005 [Full text]

Fauci AS. Seasonal and pandemic influenza preparedness: science and countermeasures. J Infect Dis 2006 Nov 1;194(suppl 2):S73-6 [Full text]

FDA. Guidance for industry: Clinical data needed to support the licensure of pandemic influenza vaccines. May 31, 2007 [Full text]

FDA. Guidance for industry: Clinical data needed to support the licensure of seasonal inactivated influenza vaccines. May 31, 2007 [Full text]

FDA. Vaccines and Related Biological Products Advisory Committee meeting transcript. Feb 27, 2007 [Full text]

Fedson DS. Author interview with David Fedson. Jun 19, 2007

Fedson DS. Pandemic influenza and the global vaccine supply. Clin Infect Dis 2003 Jun 15;36(12):1552-61 [Full text]

Fedson DS, Dunnill P. From scarcity to abundance: pandemic vaccines and other agents for "have not" countries. (Commentary) J Public Health Policy 2007;28(3):322-40 [Abstract]

Fedson DS, Dunnill P. New approaches to confronting an imminent influenza pandemic. (Commentary) Perm J 2007 Summer;11(3):63-9 [Full text]

Ferguson NM, Cummings DA, Fraser C, et al. Strategies for mitigating an influenza pandemic. (Letter) Nature 2006 Jul 27;442(7101):448-52 [Abstract]

Fraser C. Influenza pandemic vaccines: spread them thin? PLoS Med 2007 Jun;4(6):e228 [Full text]

Frist W. The Manhattan project for the 21st century. Presented at Nantucket Atheneum, Nantucket, MA, Aug 3, 2005 [Full text]

GAO (Government Accountability Office, formerly General Accounting Office). Flu vaccine: recent supply shortages underscore ongoing challenges. Testimony by Janet Heinrich before House Subcommittee on Health, Subcommittee on Oversight and Investigations, and Committee on Energy and Commerce. GAO-05-177T. Nov 18, 2004 [Full text]

GAO. Flu vaccine: steps are needed to better prepare for possible future shortages. Testimony by Janet Heinrich before US Senate Special Committee on Aging. GAO-01-786T. May 30, 2001 [Full text]

GAO. Flu vaccine: supply problems heighten need to ensure access for high-risk people. Report to Congressional Requestors. GAO-01-624. May 15, 2001 [Full text]

Germann TC, Kadau K, Longini IR, et al. Mitigation strategies for pandemic influenza in the United States. Proc Natl Acad Sci 2006 Apr 11;103(15):5935-40 [Abstract]

Goodman J. Considerations in the pre- and early pandemic use of influenza vaccine. Presented at FDA Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee Meeting, Gaithersburg, MD, Feb 27, 2007

Goodman J. How fast can a new vaccine for an emerging respiratory virus be developed and available for use? Presented at the International Conference on Emerging Infectious Diseases, Atlanta, GA, Mar 22, 2006

Gosling FG. The Manhattan Project: making the atomic bomb. Oak Ridge, TN: US Department of Energy History Division, Jan 1999

Govorkova EA, Webby RJ, Humberd J, et al. Immunization with reverse-genetics–produced H5N1 influenza vaccine protects ferrets against homologous and heterologous challenge. J Infect Dis 2006 Jul 15;194(2):159-67 [Full text]

Grady D. With few suppliers of flu shots, shortage was long in making. New York Times. Oct 17, 2004 [Full text]

GSK (GlaxoSmithKline). Backgrounder: Egg-based vs. cell-based influenza vaccine production. 2005

GSK. GlaxoSmithKline awarded $63 million HHS contract for pandemic vaccine research and development. Jan 17, 2007 [Press release]

Haaheim L. Vaccines for an influenza pandemic: scientific and political challenges. Influenza Other Respir Virus 2007;1(2):55-60 [Abstract]

Hehme N. GSK's pandemic vaccine development: from 1st to to 2nd generation candidate vaccines. Presented at the 3rd WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials, Geneva, Feb 15-16, 2007 [Full text]

Heilman C. Author interviews with Carole Heilman. Sep 13 and Sep 24, 2007

HHS (Department of Health and Human Services). HHS awards contracts totaling more than $1 billion to develop cell-based influenza vaccine. May 4, 2006 [Full text]

HHS. HHS awards two contracts to expand domestic vaccine manufacturing capacity for a potential influenza pandemic. Jun 14, 2007 [Full text]

Hoffenbach A. Update of Sanofi Pasteur EU pandemic vaccine clinical development. Presented at the 3rd WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials, Geneva, Feb 14, 2007 [Full text]

IDSA (Infectious Diseases Society of America). Pandemic and seasonal influenza principles for US action. Released Jan 25, 2007 [Full text]

IOM (Institute of Medicine). New vaccine development. 1985;1

IOM. Vaccines for the 21st century. Released Mar 1999 [Full text]

Iomai. Iomai awarded government contract, totaling $128 million, to develop dose-sparing patch for use in an influenza pandemic. Jan 17, 2007 [Press release]

Keitel W. A phase I-II, randomized, controlled, dose-ranging study of the safety, reactogenicity, and immunogenicity of intramuscular inactivated influenza A/H5N1 vaccine given alone or with aluminum hydroxide to healthy adults. Presented at the Options for the Control of Influenza VI meeting, Toronto, Jun 2007

Kotalik J. Preparing for an influenza pandemic: ethical issues. Bioethics 2005 Aug;19(4):422-31 [Abstract]

Kreijtz JH, Bodewes R, van Amerongen G, et al. Primary influenza A virus infection induces cross-protective immunity against a lethal infection with a heterosubtypic virus strain in mice. Vaccine 2007 Jan 8;25(4):612-20 [Abstract]

Kresse H. Author interview with Hedwig Kresse. Aug 2, 2007

Lauerman J. Glaxo, Novartis, hurt by drug setbacks, may lose flu-shot race. Bloomberg News. Aug 23, 2007 [Full text]

Leroux-Roels K, Borkowski A, Vanwolleghem T, et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007 Aug 18;370(9587):580-9 [Abstract]

Lin J, Zhang J, Dong X, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 2006 Sep 16;368(9540):991-7 [Abstract]

Lipatov AS, Webby RJ, Govorkova EA, et al. Efficacy of H5 influenza vaccines produced by reverse genetics in a lethal mouse model. J Infect Dis 2005 Apr 15;191(8):1216-20 [Full text]

Longini IM, Nizam A, Xu S, et al. Containing pandemic influenza at the source. Science 2005 Aug 12;309(5737):1083-7 [Abstract]

Lowen AC, Mubareka S, Tumpey TM, et al. The guinea pig as a transmission model for human influenza viruses. Proc Natl Acad Sci 2006 June 27;103(26):9988-92 [Full text]

Luke CJ, Subbarao K. Vaccines for pandemic influenza. Emerg Infect Dis 2006 Jan;12(1):66-72 [Full text]

McKenna M. System for global pandemic vaccine development challenged. Minneapolis, MN: CIDRAP News, Feb 6, 2007 [Full text]

McKenna M. Virus ownership claims could disrupt flu vaccine system. Minneapolis, MN: CIDRAP News. Jun 19, 2007 [Full text]

Monto A. Author interview with Arnold Monto. Aug 2, 2007

NIAID (National Institute of Allergy and Infectious Diseases). Report of the Blue Ribbon Panel on Influenza Research. Bethesda, Md., Sep 11-12, 2006. Posted Jun 2007 [Full text]

Nicholson KG, Colegate AE, Podda A, et al. Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenza A/duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza. Lancet 2001 Jun 16;357(9272):1937-43 [Abstract]

NIH (National Institutes of Health). Flu 2001-2008 estimated budget numbers spreadsheet, compiled for the author by NIH press office. 2007

Novartis. Flu Cell Culture Technology: The Next Frontier. 2006

Novartis. Novartis gains European approval for its innovative flu vaccine Optaflu. Jun 13, 2007, news release

Novartis. Novartis receives US government contract to further develop a novel antigen technology that could extend vaccine supplies in a pandemic outbreak. Jan 17, 2007, news release [Full text]

OIE (World Organization for Animal Health). Update on avian influenza in animals (type h5), 15 Sep 2007 [Link updated regularly]

Osterholm MT. Author interviews with Michael Osterholm. May 3 and Aug 2, 2007

Osterholm MT. Preparing for the next pandemic. Foreign Aff 2005 Jul/Aug;84(4) [Full text]

Palkonyay L. Personal communication from Laszlo Palkonyay, MD, medical officer, WHO Initiative for Vaccine Research. Oct 25, 2007

Petrovsky N. New-age vaccine adjuvants: friend or foe? BioPharm Int Aug 2, 2007

Poland GA. Author interview with Gregory Poland. Aug 1, 2007

Poland GA. Vaccines against avian influenza—a race against time. (Editorial) N Engl J Med 2006 Mar 30;354(13):1411-3 [Full text]

Protein Sciences Corp. Influenza vaccines under development. 2007 [Web page]

Riley S, Wu JT, Leung GM. Optimizing the dose of pre-pandemic influenza vaccines to reduce the infection attack rate. PLoS Med 2007 Jun;4(6):e218 [Full text]

Rosenwald MS. FluMist gets a needed boost: refrigerated version cleared. Washington Post. Jan 9, 2007 [Full Text]

Royal Society. Pandemic influenza: science to policy. Nov 2006 [Full text]

Sanofi Pasteur. Sanofi Pasteur announces completion of construction of new U.S. influenza vaccine manufacturing facility. Jul 20, 2007, news release [Full text]

Santoli J. Influenza vaccine distribution data and use of data during the 2006-07 season. Presented at the National Influenza Vaccine Summit, Atlanta, Apr 2007 [Presentation]

Schwartz B, Gellin B. Vaccination strategies for an influenza pandemic. (Commentary) J Infect Dis 2005 Apr 15;191(8):1207-9 [Full text]

Schwartz SI. Atomic audit : the costs and consequences of U.S. nuclear weapons since 1940. Washington, DC: Brookings Institution Press, 1998

Smith GJD, Fan XH, Wang J, et al. Emergence and predominance of an H5N1 influenza variant in China. Proc Natl Acad Sci 2006 Nov 7;103(45):16936-41 [Abstract]

Stephenson I, Bugarini R, Nicholson KG, et al. Cross-reactivity to highly pathogenic avian influenza H5N1 viruses after vaccination with nonadjuvanted and MF59-adjuvanted influenza A/duck/Singapore/97 (H5N3) vaccine: a potential priming strategy. J Infect Dis 2005 Apr 15;191(8):1210-5 [Full text]

Stephenson I, Gust I, Kieny MP, et al. Development and evaluation of influenza pandemic vaccines. Lancet Infect Dis 2006 Feb;6(2):71-2

Stephenson I, Gust I, Pervikov Y, et al. Development of vaccines against influenza H5. Lancet Infect Dis 2006 Aug;6(8):458-60

Stephenson I, Nicholson KG, Wood JM, et al. Confronting the avian influenza threat: vaccine development for a potential pandemic. Lancet Infect Dis 2004 Aug;4(8):499-509 [Abstract]

Strikas R. Pandemic influenza vaccine supply issues. Presented at the National Vaccine Advisory Committee Pandemic Influenza Working Group Meeting, Washington, DC, Apr 20, 2005

Subbarao K, Joseph T. Scientific barriers to developing vaccines against avian influenza viruses. Nat Rev Immunol 2007 April;7(4):267-78 [Abstract]

Thomas A, Guldager N, Hermansen K. Pandemic flu preparedness: a manufacturing perspective. BioPharm Int 2007 Aug (supp) (published online Aug 2)

Treanor JJ, Campbell JD, Zangwill KM, et al. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006 Mar 30;354(13):1343-51 [Full text]

Treanor JJ (for Goji NA, Nolan C, Hill H, et al). Immune responses of healthy subjects to a single dose of intramuscular inactivated influenza A/Vietnam/1203/2004 (H5N1) vaccine after priming with an antigenic variant. Presented at 3rd WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials, Geneva, Feb 15-16, 2007 [Full text]

Treanor JJ, Schiff GM, Couch RB, et al. Dose-related safety and immunogenicity of a trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine in elderly adults. J Infect Dis 2006 May 1;193(9):1223-8 [Full text]

Treanor JJ, Schiff GM, Hayden FG, et al. Safety and immunogenicity of a baculovirus-expressed hemagglutinin influenza vaccine: a randomized controlled trial. JAMA 2007 Apr 11;297(14):1577-82 [Abstract]

Trust for America's Health. Flu spending update: pandemic planning and resource allocation. 2007

Trust for America's Health/Infectious Diseases Society of America. Pandemic influenza: the state of the science. Oct 2006 [Full text]

Vajo Z, Kosa L, Visontay I, et al. Inactivated whole virus influenza A (H5N1) vaccine. (Letter) Emerg Infect Dis 2007 May;13(5) (published online Mar 29) [Full text]

WHO. WHO consultation on priority public health interventions before and during an influenza pandemic. Apr 27, 2004

WHO. Global Advisory Committee on Vaccine Safety, 6-7 June 2006. Meeting report released Jun 14, 2006 [Full text]

WHO. Global pandemic influenza action plan to increase vaccine supply. Released Oct 23, 2006 [Full text]

WHO. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO, 10 Sep 2007

WHO. Projected supply of pandemic influenza vaccine sharply increases. Oct 23, 2007 [Press release]

Wood JM. Author interview with John Wood. Jun 18, 2007

Wood JM. International standards for H5N1 antibodies. Presented at the 3rd WHO meeting on evaluation of pandemic influenza prototype vaccines in clinical trials, Geneva, Feb 15-16, 2007 [Full text]

Wood JM. Reference viruses for seasonal and pandemic influenza vaccine preparation. Influenza Other Respir Virus 2007 Jan;1(1):5-9 [Abstract]

Working Group for Pandemic Influenza Preparedness. Letter to Congress. Jun 5, 2007

Working Group for Pandemic Influenza Preparedness. Letter to Congress. May 23, 2006

Working Group for Pandemic Influenza Preparedness. Letter to Congress. Nov 10, 2005 [Full text]

Zangwill K, Campbell J, Noah D, et al. Evaluation of a third dose of subvirion H5N1 influenza vaccine (rgA/Vietnam/1203/04 x PR8) in healthy adults. Presented at Options for the Control of Influenza VI, Toronto, Jun 17-23, 2007

The series: The pandemic vaccine puzzle

Part 1: Flu research: a legacy of neglect
Part 2: Vaccine production capacity falls far short
Part 3: H5N1 poses major immunologic challenges
Part 4: The promise and problems of adjuvants
Part 5: What role for prepandemic vaccination?
Part 6: Looking to novel vaccine technologies
Part 7: Time for a vaccine 'Manhattan Project'?
Bibliography [you are here]

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