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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~ ~~

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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

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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

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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

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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