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Immunization Safety Review: Influenza Vaccines and Neurological Complications (2004)

Chapter: Appendix C: Chronology of Important Events Regarding Vaccine Safety

« Previous: Appendix B: Public Meeting Agenda, March 13, 2003
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." 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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Page 170
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." 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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Page 171
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2004. Immunization Safety Review: Influenza Vaccines and Neurological Complications. Washington, DC: The National Academies Press. doi: 10.17226/10822.
×
Page 172
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." 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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Page 173
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." 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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Page 174

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Appendix ~ Cbronology of Wont Events Recoding Vaccine Sooty Year ~~e [icensure Leg~lndon armor IBM Repods on PoMcy Statements Vaccine Saw 1933 waved Is vaccine (IPV) avaU~le 1963 ~ as vaccine (OPV) _, Is ~ Measles vaccine allele 1967 1969 1971 1977 gums vaccine avaU~le RubeUa vaccine av~l~le easles-~u~s-RubeHa (WAR) vaccine av~l~le 1979 Current ~rmuladon of rubella vaccine av~l~le replaces earlier versions 1982 Plasma-de~ved bep~ds B . ·. . . vane me gums vaccination recommended 7~ fo/~ffi~ ~~

APPENDIX C 171 Vaccine Year Licensure Legislation and/or Policy Statements IOM Reports on Vaccine Safety 1985 Hib vaccine licensed for children >15 months 1986 1988 1990 Congress passes Public Law 99-660, the National Childhood Vaccine Injury Act (introduced in 1984) calls for: · est. of NVPO · est. of NVAC · est. of VICP · est. of ACCV IOM review of 1) pertussis and rubella, 2) routine child vaccines 2 Hib conjugate vaccines licensed for use beginning at 2 months Evaluation of Poliomyelitis Vaccine Policy Options 1991 Acellular pertussis Hepatitis B Adverse Effects of Pertussis component licensed for the recommended by ACIP and Rubella Vaccines 4th and 5th doses of the for addition to 5-part DTP series in ACEL-IMUNE childhood immunization schedule ACIP recommends Hib be added to childhood immunization schedule 1992 Acellular pertussis Hepatitis B vaccine: component licensed for the Added universal 4th and 5th doses of the vaccination for all 5-part DTP series in infants, high-risk Tripedia adolescents (e.g., IV drug users, persons with multiple sex partners) 1993 Combined DTP and Hib vaccine (Tetramune) licensed

172 IMMUNIZATION SAFETY REVIEW Vaccine Year Licensure Legislation and/or Policy Statements IOM Reports on Vaccine Safety 1994 1995 1996 Varicella virus vaccine available (Varivax) DTaP vaccine licensed for first three doses given in infancy (Tripedia and ACEL-IMUNE were ACIP recommends using IPV for the first 2 polio vaccinations, followed by OPV for previously licensed for only remaining doses. the 4th and 5th doses). Intended to be a transitional schedule for 3-5 years until an all-IPV series is available ACIP recommends children 12months- 12 years receive Varicella vaccine 1997 Additional DTaP vaccine ACIP recommends (Infanrix) licensed for first DTaP in place of DTP 4 doses of 5-part series 1998 Additional DTaP vaccine (Certiva) licensed for first 4 doses of 5-part series Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality DPT and Chronic Nervous System Dysfunction: A New Analysis Options for Poliomyelitis Vaccinations in the United States: Workshop Summary Vaccine Safety Forum: Summary of Two Workshops Risk Communication and Vaccination: Workshop Summary ACIP updates MMR recommendation, encouraging use of the combined MMR vaccine

APPENDIX C 173 Vaccine Year Licensure Legislation and/or Policy Statements IOM Reports on Vaccine Safety 1999 2000 2001 Additional supply of thimerosal-free hepatitis B vaccine made available Pneumococcal vaccine for infants and young children licensed (Prevnar) ACIP updates varicella vaccine recommendation, requiring immunity for child care and school entry ACIP recommends an all-IPV schedule begin January 2000 to prevent cases of vaccine-associated paralytic polio AAP and PHS recommend removal of thimerosal from vaccines Also recommended postponement of hepatitis B vaccine from birth to 2-6 months for infants of hepatitis B surface antigen-negative mothers MMWR notifies readers of the availability of a thimerosal-free hepatitis B vaccine, enabling the resumption of the birth dose ACIP recommends pneumococcal vaccination for all children 2-23 months, and at-risk children 24-59 months (e.g., immunocompromised) October: ACIP drafts statement expressing a preference for use of thimerosal-free DTaP, Hib, and Hep B vaccines by March 2002 Immunization Safety Review: Measles-Mumps- Rubella Vaccine and Autism Immunization Safety Review: Thimerosal- Containing Vaccines and Neuro-developmental Disorders

174 IMMUNIZATION SAFETY REVIEW Vaccine Year Licensure Legislation and/or Policy Statements IOM Reports on Vaccine Safety 2002 Immunization Safety Review: Multiple Immunizations and Immune Dysfunction Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer 2003 Live attenuated intranasal ACIP recommends Immunization Safety influenza vaccine that children 6 to Review: Hepatitis B approved for use in the 23 months of age be Vaccine and Demyelinating United States in healthy vaccinated annually Neurological Disorders individuals aged against influenza 5-49 years old (FluMist) beginning in the Immunization Safety 2004-2005 influenza Review: SV40 season Contamination of Polio Vaccine and Cancer Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy l

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Immunization Safety Review: Influenza Vaccines and Neurological Complications Get This Book
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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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