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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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Suggested Citation:"References." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
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INFLUENZA VACCINES AND NEUROLOGICAL COMPLICATIONS REFERENCES 147 Albert LJ, Inman RD. 1999. Molecular mimicry and autoimmunity. NEngl JMed 341(27):2068-74. Alter M, Leibowitz U. Speer J. 1966. Risk of multiple sclerosis related to age at immigration to Israel. Arch Neurol 15(3):234-7. Asbury AK. 2000. New concepts of Guillain-Barre syndrome. J Child Neurol 15(3):183-91. ATSDR (Agency for Toxic Substances and Disease Registry). 1999. Toxicological Profile for Mercury (Update). Bach IF, Chatenoud L. 2001. Tolerance to islet autoantigens in type 1 diabetes. Annu Rev Immunol 19:131-61. Bakshi R. Mazziotta JC. 1996. Acute transverse myelitis after influenza vaccination: magnetic reso- nance imaging findings. J. Neuroimaging 6(4):248-50. Bamford CR, Sibley WA, Laguna IF. 1978. Swine influenza vaccination in patients with multiple sclerosis. Arch Neurol 35(4):242-3. Belshe RB, Couch RB, Glezen WP, Treanor IT. 2002. Live attenuated intranasal influenza vaccine. Vaccine 20(29-30):3429-30. Benoist C, Mathis D. 2001. Autoimmunity provoked by infection: how good is the case for T cell epitope mimicry? Nat Immunol 2(9):797-801. Berna Biotech Ltd. 2002. News Release: Berna Biotech to accelerate development of a 2nd genera- tion nasal flu vaccine product. [online] Available at: http://www.bernabiotech.com/news/ archive/article/20020606_01.html [accessed June 6, 2002]. Beyer WE, Palache AM, Osterhaus ADME. 1998. Comparison of serology and reactogenicity between influenza subunit vaccines and whole virus or split vaccines: a review and meta- analysis of the literature. Clin Drug Invest; 15(1):1-12. Beyer WE, Palache AM, de Jong JC, Osterhaus AD. 2002. Cold-adapted live influenza vaccine versus inactivated vaccine: systemic vaccine reactions, local and systemic antibody response, and vaccine efficacy. A meta-analysis. Vaccine 20(9-10):1340-53. Bostrom A. 1997. Vaccine risk communication: Lessons from risk perception, decision making and environmental risk communication research. Risk. [online] Available at: http://www.piercelaw. edu/risk/vol8/spring/bostrom.htm. Breman JG, Hayner NS. 1984. Guillain-Barre syndrome and its relationship to swine influenza vaccination in Michigan, 1976-1977. Am JEpidemiol 119(6):880-9. Bridges C, Thompson W. Meltzer M, Reeve G. Talamonti W. Cox N. Lilac H. Hall H. Klimov A, Fukuda K. 2000. Effectiveness and cost-benefit of influenza vaccination of healthy working adults: a randomized controlled trial. JAMA 284(13):1655-63. Brooks R. Reznik A. 1980. Guillain-Barre syndrome following trivalent influenza vaccine in an elderly patient. Mt Sinai J Med 47(2): 190-1. Brostoff SW, White TM. 1982. Absence of P2 protein in swine flu vaccines. JAMA 247(4):495. Burwen D. 2003 (March 13). Use of Medicare Data to Evaluate Adverse Events After Influenza Vaccine. Presentation to the Institute of Medicine Meeting on Influenza Vaccine and Neuro- logical Complications, Washington, DC. Institute of Medicine. Immunization Safety Review Committee. Buzby JC, Allos BM, Roberts T. 1997. The economic burden of Campylobacter-associated Guillain- Barre syndrome. JInfectDis 176 Suppl 2:S192-7. CDC.l999. Primary and Secondary Syphilis United States, 1998. MMWR 48(30):885-90. CDC. 2002a. Epidemiology and Prevention of Vaccine-Preventable Diseases 7th Edition. Public Health Foundation. CDC. 2002b. Prevention and Control of Influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP); MMWR Morb Mortal Wkly Rep 51(RR03):1-31. CDC. 2002c. Surveillance for Influenza United States, 1997-98, 1998-99, and 1999-00 Seasons. MMWR Morb Mortal Wkly Rep 51(SS-7):1-10.

148 IMMUNIZATION SAFETY REVIEW CDC. 2003a. Infant Botulism New York City, 2001-2002. MMVER Morb Mortal Wkly Rep 52 (2):26-28. CDC. 2003b. Influenza and Pneumococcal Immunization: a Qualitative Assessment of the Beliefs of Physicians and Older Hispanic and African Americans. [online] Available at: http:// www.cdc.gov/nip/flu/flu_qualresearch.htm. [accessed September 9, 2003]. CDC. 2003c. National Center for Infectious Diseases. Influenza: The Disease. [online] Available at: www.cdc.gov/ncidod/diseases/flu/fluinfo.htm [accessed March 20, 2003]. CDC. 2003d. Prevention and control of influenza: Recomendations of the Advisory Committee on Immunization Practices (ACIP). MMVER Morb Mortal Wkly Rep 52 (RR08): 1-36. CDC. 2003e. Personal Communication with P. Haber. VAERS reports. March, 2003. Cha TA, Kao K, Zhao J. Fast PE, Mendelman PM, Arvin A. 2000. Genotypic stability of cold- adapted influenza virus vaccine in an efficacy clinical trial. J Clin Microbiol 38(2):839-45. Chen R. 2003 (March 13). Studies Of Guillain-Barre Syndrome (GBS) After Influenza Vaccination. Presentation to the Immunization Safety Review Committee, Washington, DC. Confavreux C, Suissa S. Saddler P. Bourdes V, Vukusic S. for the Vaccines in Multiple Sclerosis Study Group. 2001. Vaccinations and the risk of relapse in multiple sclerosis. N Engl J Med 344(5):319-326. Davidson A, Diamond B. 2001. Autoimmune diseases. N Engl J Med 345(5):340-50. De Keyser J. Zwanikken C, Boon M. 1998. Effects of influenza vaccination and influenza illness on exacerbations in multiple sclerosis. JNeurol Sci 159(1):51-3. Department of Health and Human Services (DHHS). 2003. Product Approval Information. [online] Available at: www.fda.gov/cber/approvltr/inflmedO61703L.htm [accessed July 16, 2003]. DeStefano F. Verstraeten T. Jackson LA, Okoro C, Benson P. Black S. Shinefield H. Mullooly P. Likosky W. Chen R. 2003. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol 60:504-9. Dolin R. 2001. Influenza. In: Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL, Jameson JL, eds. Harrison's Principles of Internal Medicine. 15th ed. New York: McGraw-Hill. Pp. 1125-30. Dowdle WR. 1997. Pandemic influenza: confronting a re-emergent threat. The 1976 experience. J Infect Dis 176 Suppl 1 :S69-72. Ellenberg S. Chen R. 1997. The complicated task of monitoring vaccine safety. Public Health Reports 112:10-20. EPA (Environmental Protection Agency). 1997. Mercury Study Report to Congress: Volume 1 Ex- ecutive Summary. EPA 452/R-97-003. Evans DM, Dunn G. Minor PD, Schild GC, Cann AJ, Stanway G. Almond JW, Currey K, Maizel JV. 1985. Nature 11-17;314(6011):548-50 Fischoff B. Slovic P. Lichtenstein S. Read S. Combs B. 2000. How safe is safe enough? A psycho- metric study of attitudes toward technological risks and benefits. In: Slovic P. ed. The Percep- tion of Risk. London: Earthscan Publications. France E. 2003 (March 13). Safety of the Trivalent Inactivated Influenza Vaccine (TIV) Among Children: A Population-Based Study. Presentation to the Immunization Safety Review Com- mittee. Washington, DC. Fu TM, Guan L, Friedman A, Schofield TL, Ulmer JB, Liu MA, Donnelly JJ. 1999. Dose depen- dence of CTL precursor frequency induced by a DNA vaccine and correlation with protective immunity against influenza virus challenge. J Immunol 162(7):4163-70. Geier M, Geier D, Zahalsky A. 2003. Influenza vaccination and Guillain-Barre syndrome. Clin Immun 107 (2003):116-21. Gonzalez M, Pirez MC, Ward E, Dibarboure H. Garcia A, Picolet H. 2000. Safety and immuno- genicity of a paediatric presentation of an influenza vaccine. Arch Dis Child 83(6):488-91. Griffin J. 2003 (March 13). Guillain-Barre' Syndrome. Presentation to the Immunization Safety Review Committee. Washington, DC..

INFLUENZA VACCINES AND NEUROLOGICAL COMPLICATIONS 149 Haber P. 2003 (March 13). Influenza Vaccine and Neurological Adverse Events. VAERS 7/1990 - 1/ 2003. Presentation to the Immunization Safety Review Committee. Washington, DC. Hahn AF. 1996. Experimental allergic neuritis (EAN) as a model for the immune-mediated demyeli- nating neuropathies. Rev Neurol (Paris) 152(5):328-32. Halperin SA, Smith B. Mabrouk T. Germain M, Trepanier P. Hassell T. Treanor J. Gauthier R. Mills EL. 2002. Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture- derived influenza vaccine in healthy adults, seniors, and children. Vaccine 20(7-8):1240-7. Hamada T. Driscoll BE, Kies MW, Alvord EC Jr. 1989. LPS augments adoptive transfer of experi- mental allergic encephalomyelitis in the Lewis rat. Autoimmunity 2(4):275-84. Hilleman MR. 2002. Realities and enigmas of human viral influenza: pathogenesis, epidemiology and control. Vaccine 20(25-26):3068-87. Hjorth RN, Bonde GM, Finer E, Hartzell RW, Rorke LB, Rubin BA. 1984. Experimental neuritis induced by a mixture of neural antigens and influenza vaccines. A possible model for Guillain- Barre syndrome. JNeuroimmunol 6(1):1-8. Hochberg F. Nelson K, Janzen W. 1975. Influenza type B-related encephalopathy. The 1971 out- break of Reye syndrome in Chicago. JAMA 231(8):817-21. Houff SA, Miller GL, Lovell CR, Wallen WC, Madden DL, Sever JL, Dolin R. 1977. The Guillain- Barre syndrome and swine influenza vaccination. Trans Am Neurol Assoc 102: 120-3. Hughes RA, Rees JH. 1997. Clinical and epidemiologic features of Guillain-Barre syndrome. JInfect Dis 176 Suppl 2:S92-8. Hughes RA, Raphael JC, Swan AV, van Doorn PA. 2001. Intravenous immunoglobulin for Guillain- Barre syndrome. Cochrane Database Syst Rev (2):CD002063. Hurwitz ES, Schonberger LB, Nelson DB, Holman RC. 1981. Guillain-Barre syndrome and the 1978-1979 influenza vaccine. NEngl JMed 304(26):1557-61. IOM (Institute of Medicine). 1991. Adverse Events Following Pertussis and Rubella Vaccines. Washington DC: National Academy Press. IOM (Institute of Medicine).1994a. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington DC: National Academy Press. IOM (Institute of Medicine). 1994b. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Washington DC: National Academy Press. IOM (Institute of Medicine). 2001a. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism. Washington, DC: National Academy Press. IOM (Institute of Medicine). 2001b. Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. Washington DC: National Academy Press. IOM (Institute of Medicine). 2001c. Multiple Sclerosis: Current Status and Strategies for the Future. Washington DC: National Academy Press. IOM (Institute of Medicine). 2002a. Immunization Safety Review: Hepatitis B Vaccine and Demyeli- nating Neurological Disorders. Washington DC: National Academy Press. IOM (Institute of Medicine). 2002b. Immunization Safety Review: Multiple Immunizations and Immune Dysfunction. Washington DC: National Academy Press. IOM (Institute of Medicine). 2002c. Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer. Washington, DC: The National Academies Press. IOM (Institute of Medicine). 2003. Immunization Safety Review: Sudden Uxexpected Death in Infancy. Washington, DC: The National Academies Press. Jacobs BC, Rothbarth PH, van der Meche FG, Herbrink P. Schmitz PI, de Klerk MA, van Doorn PA. 1998. The spectrum of antecedent infections in Guillain-Barre syndrome: a case-control study. Neurology 51(4): 1110-5. Jahnke U. Fischer EH, Alvord EC Jr. 1985. Sequence homology between certain viral proteins and proteins related to encephalomyelitis and neuritis. Science 229(4710):282-4. Johnson DE. 1982. Guillain-Barre syndrome in the U.S. Army. Arch Neurol 39(1):21-4. Joseph SA, Tsao CY. 2002. Guillain-Barre syndrome. Adolesc Med 13(3):487-94.

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Infection with the influenza virus can have a serious effect on the health of people of all ages, although it is particularly worrisome for infants, the elderly, and people with underlying heart or lung problems. A vaccine exists (the “flu” shot) that can greatly decrease the impact of influenza. Because the strains of virus that are expected to cause serious illness and death are slightly different every year, the vaccine is also slightly different every year and it must be given every year, unlike other vaccines.

The Immunization Safety Review committee reviewed the data on influenza vaccine and neurological conditions and concluded that the evidence favored rejection of a causal relationship between influenza vaccines and exacerbation of multiple sclerosis. For the other neurological conditions studied, the committee concluded the evidence about the effects of influenza vaccine is inadequate to accept or reject a causal relationship. The committee also reviewed theories on how the influenza vaccine could damage the nervous system. The evidence was at most weak that the vaccine could act in humans in ways that could lead to these neurological problems.

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