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955 963 967 971 977 979 982 Appendix C Chronology of Important Events Regarding Vaccine Safety Year Vaccine Licensure Legislation and/or TOM Reports on Policy Statements Vaccine Safety Activated poliomyelitis vaccine (IPV) available Oral poliomyelitis vac- cine (OPV) available, replaces IPV Measles vaccine available Mumps vaccine available Rubella vaccine available Measles -Mump s-Rubella (MMR) vaccine available Current formulation of rubella vaccine available, replaces earlier versions Plasma-derived hepatitis B vaccine available 1985 Hib vaccine licensed for Mumps vaccination recommended Evaluation of Poliomyelitis Vaccines 98
APPENDIX C 99 Year Vaccine Licensure Legislation and/or TOM Reports on Policy Statements Vaccine Safety children >15 months 1986 1988 990 991 1992 1993 1994 Acellular pertussis com- ponent licensed for the 4 and So doses of the S-part DTP series in Tripedia Combined DTP and Hib vaccine (Tetramune) licensed 1995 Varicella virus vaccine available (Varivax) Congress passes Public Law 99-660, the National Child- hood Vaccine Injury Act (in- troduced 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 vac- cines 2 Hib conjugate vaccines licensed for use begin- ning at 2 months Evaluation of Polio- myelitis Vaccine Policy Options Acellular pertussis com- Hepatitis B recommended by Adverse Ejects of portent licensed for the Oh ACIP for addition to childhood Pertussis and Ru- and 5~ doses of the 5-part immunization schedule bella Vaccines DTP series in ACEL- IMUNE ACIP recommends Hib be added to childhood immuniza- tion schedule Hepatitis B vaccine: Added universal vaccination for all infants, high-risk adolescents (e.g., IV drug users, persons win multiple sex parmers) Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality DPT and Chronic Nervous System Dysfunction: A New Analysis
100 I M M U N I Z A T I O N S A F E T Y R E V I E W Year Vaccine Licensure Legislation and/or Policy Statements ACIP recommends using IPV for the first 2 polio vaccina- tions, followed by OPV for remaining doses. Intended to be a transitional schedule for 3-5 years until an all-IPV series is available TOM Reports on Vaccine Safety Options for Polio- myelitis Vaccinations in the United States: Workshop Summmy 996 997 998 999 DTaP vaccine licensed for first three doses given in infancy (Tripedia and ACEL-IMUNE were previously licensed for only the 4~ and 5th doses). Additional DTaP vaccine (Infanrix) licensed for first 4 doses of 5-part series Additional DTaP vaccine (Certiva) licensed for first 4 doses of 5-part series Additional supply of thimerosal-free hepatitis B vaccine made available 2000 Pneumococcal vaccine for infants and young ACIP recommends children 12months - 12 years receive Varicella vaccine ACIP recommends DTaP in place of DTP ACIP updates MMR recom- mendation, encouraging use of the combined ME vaccine 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 postpone- ment of hepatitis B vaccine from birth to 2-6 months for infants of hepatitis B surface antigen-negative mothers MOOR notifies readers of the availability of a thimerosal-free hepatitis B vaccine, enabling the resumption of the birth dose AC IP recommends p neumo - coccal vaccination for all Vaccine Safety Fo- rum: Summary of Two Workshops Risk Communication and Vaccination: Workshop Summary
APPENDIX C 101 Year Vaccine Licensure Legislation Policy Statements and/or TOM Reports on Vaccine Safety 2001 2002 children licensed (Prev- children 2-23 months, and at- nar) risk children 2059 months (e.g., immunocompromised) October: ACIP drafts statement Immunization Safety expressing a preference for use Review: Measles- of thimerosal-free DTaP, Hib, Mumps-Rubella and Hep B vaccines by March Vaccine and Autism 2002 Immunization Safety Review: Thimerosal- Containing Vaccines and Neurodevelop- mental Disorders Immunization Safety Review: Multiple Immunizations and Immune Dysfunction Immunization Safety Review: Hepatitis B Vaccine and Demye- linating Neurological Disorders