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Appendix C Chronology of Important Events Regarding Vaccine Safety Year Vaccine Licensure Legislation and/or Policy Statements IOM Reports on Vaccine Safety 1955 1963 Inactivated poliomyelitis vaccine (IPV) available Oral poliomyelitis vaccine (OPV) available, replaces IPV Measles vaccine available 1967 Mumps vaccine available 1969 Rubella vaccine available 197 1 Measles-Mumps-Rubella (MMR) vaccine available 1977 1979 Current formulation of rubella vaccine available, replaces earlier versions 1982 Plasma-derived hepatitis B vaccine available Mumps vaccination recommended 98 Evaluation of Poliomyelitis Vaccines

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APPENDIX C 99 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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100 IMMUNIZATION SAFETY REVIEW Vaccine Year Licensure Legislation and/or Policy Statements IOM Reports on Vaccine Safety 1994 1995 Varicella virus vaccine available (Varivax) 1996 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 1999 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 ACIP updates varicella vaccine recommendation, . . . r requiring Immunity for child care and school entry

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APPENDIX C 10 Vaccine Year Licensure Legislation and/or Policy Statements IOM Reports on Vaccine Safety ACIP recommends an all-IPV schedule begin January 2000 to prevent cases of vaccine-associated paralytic polio AAP and PHS recommend removal of thimerosal r Irom vaccines Also recommended postponement of hepatitis B vaccine from birth to 2-6 months for infants of hepatitis B surface antigen-negative mothers Additional supply of thimerosal-free hepatitis B vaccine made available 2000 2001 MMWR notifies readers of the availability of a thimerosal-free hepatitis B vaccine, enabling the resumption of the birth dose Pneumococcal vaccine for infants and young children licensed (Prevnar) 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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102 IMMUNIZATION SAFETY REVIEW Vaccine Year Licensure Legislation and/or Policy Statements TOM 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