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PAPERBACK list:$29.95 Web:$26.95 add to cart PDF BOOK your price: $23.00 add to cart Rights & Permissions Free Resources PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles The Threat of Pandemic Influenza: Are We Ready? Workshop Summary Ensuring an Infectious Disease Workforce: Education and Training Needs for the 21st Century - Workshop Summary Other Related Titles The Children's Vaccine Initiative: Achieving the Vision (1993) Institute of Medicine (IOM) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 196   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. H Historical Record of Vaccine Product License Holders in the United States TABLE H-1 Vaccine Product License Holders in the United States Company and Vaccine or Product Date of License Date of Revocation Bionetics Research Inc.a     BCG vaccine 05/29/1987 06/21/1989 Connaught Laboratories, Inc.b     BCG live 05/21/1990   BCG vaccine 03/31/1967 05/21/1990 Diphtheria & tetanus toxoids & acellular pertussis vaccine, adsorbed 09/20/1992   Diphtheria & tetanus toxoids & pertussis vaccine (DTP) 01/03/1978 11/29/1982 Diphtheria & tetanus toxoids, & pertussis vaccine, adsorbed 01/03/1978   Diphtheria & tetanus toxoids adsorbed 09/18/1984   Diphtheria toxoid 01/03/1978   Haemophilus influenzae type b Conjugate     (diphtheria toxoid conjugate) 12/22/1987 Page 196 FRONT MATTER (R1-R16) 1 Executive Summary (1-18) 2 Why a Children's Vaccine Initiative (19-35) 3 Resources and Infrastructure (36-65) 4 Vaccine Demand and Supply (66-97) 5 Investing in New and Improved Vaccines (98-108) 6 Stages of Vaccine Development (109-127) 7 A Strategy to Enhance U.S. Participation in the Children's Vaccine Initiative (128-146) Appendix A: Relevant Intellectual Property Rights Law (147-159) Appendix B: National Vaccine Injury Compensation Program (160-163) Appendix C: Regulatory Aspects of Vaccine Development, Manufacture, and Distribution (164-169) Appendix D: Strategies for Achieving Full U.S. Participation in the Children's Vaccine Initiative (170-183) Appendix E: Public Health Service Act (1944) (184-188) Appendix F: National Vaccine Program Legislation (189-192) Appendix G: Immunization Schedules (193-195) Appendix H: Historical Record of Vaccine Product License Holders in the United States (196-204) Appendix I: Working Group Participants (205-209) Appendix J: Committee and Staff Biographies (210-219) Appendix K: Acronyms (220-221)

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OCR for page 196
The Children's Vaccine Initiative: Achieving the Vision H Historical Record of Vaccine Product License Holders in the United States TABLE H-1 Vaccine Product License Holders in the United States Company and Vaccine or Product Date of License Date of Revocation Bionetics Research Inc.a     BCG vaccine 05/29/1987 06/21/1989 Connaught Laboratories, Inc.b     BCG live 05/21/1990   BCG vaccine 03/31/1967 05/21/1990 Diphtheria & tetanus toxoids & acellular pertussis vaccine, adsorbed 09/20/1992   Diphtheria & tetanus toxoids & pertussis vaccine (DTP) 01/03/1978 11/29/1982 Diphtheria & tetanus toxoids, & pertussis vaccine, adsorbed 01/03/1978   Diphtheria & tetanus toxoids adsorbed 09/18/1984   Diphtheria toxoid 01/03/1978   Haemophilus influenzae type b Conjugate     (diphtheria toxoid conjugate) 12/22/1987

OCR for page 197
The Children's Vaccine Initiative: Achieving the Vision Company and Vaccine or Product Date of License Date of Revocation Haemophilus influenzae type b polysaccharide 12/20/1985   Influenza 01/03/1978   Meningococcal polysaccharide group A 01/03/1978   Meningococcal polysaccharide group C 01/03/1978   Meningococcal polysaccharide vaccine, groups A and C combined 01/03/1978   Meningococcal polysaccharide vaccine, groups A, C, Y, W135 combined 11/23/1981   Pertussis vaccine 01/03/1978   Poliomyelitis virus, inactivated human diploid cell 11/20/1987   Poliomyelitis virus, inactivated monkey kidney cell 01/24/1963   Rabies vaccine 12/27/1991   Smallpox vaccine 01/03/1978   Tetanus toxoid 01/03/1978   Tetanus toxoid, adsorbed 01/03/1978   Tetanus & diphtheria toxoids adsorbed (for adult use) 01/03/1978   Yellow fever 01/03/1978   Connaught Laboratories, Limitedb     Diphtheria toxoid 04/28/1928 05/27/1977 Tetanus toxoid 01/14/1943   Small pox vaccine 10/23/1967 04/01/1980 Dow Chemical Companya     Diphtheria & tetanus toxoids & pertussis vaccine adsorbed 09/11/1970 06/07/1977 Diphtheria toxoid 09/18/1934 06/07/1977 DT, adsorbed 09/11/1970 06/07/1977 DP, adsorbed 09/11/1970 06/07/1977 Measles, live 02/05/1965 06/07/1978 Measles and rubella, live 04/17/1974 06/21/1978 Measles, mumps, rubella, live 04/17/1974 06/21/1978 Mumps virus vaccine, live 04/17/1974 06/21/1978 Pertussis vaccine 10/01/1932 06/07/1977 Rubella virus, live 03/01/1974 06/21/1978 Tetanus toxoid 08/01/1936 06/07/1977 Tetanus toxoid, adsorbed 09/01/1970 06/07/1977 Eli Lilly and Companya     Cholera 10/31/1917 06/07/1979 Diphtheria & tetanus toxoids 09/09/1970 06/07/1979

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The Children's Vaccine Initiative: Achieving the Vision Company and Vaccine or Product Date of License Date of Revocation Diphtheria & tetanus toxoids, and pertussis vaccine adsorbed 09/09/1970 12/02/1985 DT, adsorbed 09/09/1970 06/07/1979 Influenza 11/09/1945 04/11/1977 Mumps vaccine 01/27/1950 04/11/1977 Pertussis vaccine 03/31/1915 03/07/1978 Rabies vaccine 06/07/1915 08/11/1982 Streptococcus vaccine 04/17/1952 10/27/1988 Tetanus toxoid 12/10/1935 06/07/1979 Tetanus toxoid, adsorbed 09/09/1970 06/07/1979 Tetanus & diphtheria toxoid adsorbed (for adult use) 09/09/1970 06/07/1979 Typhoid 02/04/1954 11/13/1978 Typhus 03/11/1941 06/07/1979 Evans Medical Ltd.c     Influenza 08/12/1988   Glaxo Operations, U.K. Ltd.a     BCG vaccine 01/24/1963 07/17/1990 Lederle Laboratories,d     American Cyanamid Company     Cholera 12/26/1941   Diphtheria & tetanus toxoids and acellular pertussis, adsorbed 12/17/1991   Diphtheria & tetanus toxoids and pertussis vaccine adsorbed 07/24/1970   DT, adsorbed 07/29/1970   Haemophilus influenzae type b polysaccharide vaccine 12/20/1985   Influenza 12/07/1945   Measles virus, live 05/03/1966 05/21/1980 Mumps vaccine 06/22/1950 05/24/1978 Pertussis vaccine 01/19/1914 05/29/1980 Pneumococcal vaccine, polyvalent 08/15/1979   Polio virus, live, oral trivalent 06/25/1963   Polio virus, oral, type 1 03/27/1962   Polio virus, oral, type 2 03/27/1962   Polio virus, oral, type 3 03/27/1962   Rocky mountain spotted fever 04/13/1942 06/11/1979 Small pox 03/01/1937 05/24/1978 Tetanus toxoid 06/15/1935   Tetanus toxoid, adsorbed 07/29/1970

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The Children's Vaccine Initiative: Achieving the Vision Company and Vaccine or Product Date of License Date of Revocation Tetanus & Diphtheria toxoids adsorbed (for adult use) 07/29/1970   Typhus 05/24/1967 11/20/1980 Massachusetts Public Health Biologic Laboratories     Diphtheria & tetanus toxoids & pertussis vaccine adsorbed 07/27/1970   Diphtheria toxoid 07/07/1932 05/19/1980 DT, adsorbed 07/27/1970   Small pox 03/20/1917 12/22/1976 Tetanus toxoid 05/16/1949 10/11/1989 Tetanus toxoid, adsorbed 07/29/1970   Tetanus & diphtheria toxoids adsorbed (for adult use) 07/27/1970   Typhoid 03/20/1917 10/26/1988 Merck and Company     Cholera 05/04/1952 01/31/1986 Diphtheria & tetanus toxoids and pertussis vaccine adsorbed 08/31/1970 01/31/1986 Haemophilus influenzae type b conjugate (meningococcal protein conjugate) 2/20/1989   Hepatitis B vaccine 11/16/1981   Hepatitis B recombinant 07/23/1986   Influenza 11/30/1945   Measles, live and small pox 11/17/1967 05/12/1987 Measles virus, live 03/21/1963   Measles and mumps virus, live 07/18/1973   Measles and rubella virus, live 04/22/1971   Measles, mumps, rubella, live 04/22/1971   Meningococcal polysaccharide A 07/11/1975   Meningococcal polysaccharide C 04/02/1974   Meningococcal polysaccharide A&C 10/06/1975   Meningococcal polysaccharide A. C, Y, W135 combined 12/14/1982   Mumps virus, live 12/28/1967   Pneumococcal 11/21/1977   Poliomyelitis, inactivated monkey kidney cell 04/12/1955 07/29/1980 Rubella virus, live 06/09/1969   Rubella and mumps, live 08/30/1970   Small pox 09/21/1965 07/29/1980 Tetanus toxoid 12/11/1933 01/31/1986 Tetanus toxoid, adsorbed 08/31/1970 01/31/1986

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The Children's Vaccine Initiative: Achieving the Vision Company and Vaccine or Product Date of License Date of Revocation Tetanus & diphtheria toxoids adsorbed (for adult use) 08/31/1970 01/31/1986 Typhoid 04/25/1963 01/31/1986 Typhus 12/24/1941 07/29/1980 Merrell-National Laboratories, Division of Richardson Merrella     Cholera 02/27/1942 03/25/1976 DTP 10/15/1970 01/03/1978 Diphtheria & tetanus toxoids & pertussis vaccine adsorbed 05/16/1949 01/03/1978 Diphtheria toxoid 09/28/1929 01/03/1978 Influenza 09/16/1947 01/03/1978 Meningococcal polysaccharide group A 09/19/1975 01/03/1978 Meningococcal polysaccharide group C 07/11/1975 01/03/1978 Meningococcal polysaccharide vaccine, groups A and C, combined 09/13/1976 01/03/1978 Pertussis vaccine 11/16/1926 01/03/1978 Small pox 03/05/1937 01/03/1978 Tetanus toxoid 05/25/1934 01/03/1978 Tetanus toxoid, adsorbed 10/15/1970 01/03/1978 Tetanus and diphtheria toxoids adsorbed (for adult use) 03/07/1955 01/03/1978 Yellow fever 05/22/1953 01/03/1978 Michigan Department of Public Health     Anthrax 11/04/1970   Diphtheria & tetanus toxoids and pertussis vaccine adsorbed 08/27/1970   DT, adsorbed 08/27/1970   Pertussis vaccine 11/22/1935 02/03/1977 Pertussis vaccine, adsorbed 10/12/1967   Rabies vaccine, adsorbed 03/18/1988   Smallpox 03/03/1937 06/25/1985 Tetanus toxoid, adsorbed 08/27/1970   Typhoid 07/26/1926 06/25/1985 Miles Inc.e     Cholera 10/03/1968 10/30/1970 Diphtheria and tetanus toxoids 06/01/1951 10/30/1970 DTP 05/04/1949 10/30/1970 Diphtheria & tetanus toxoids and pertussis vaccine adsorbed 05/04/1949 10/30/1970 Diphtheria toxoid 02/01/1928 10/30/1970 DT, adsorbed 05/04/1949 10/30/1970 DP, adsorbed 05/04/1949 10/30/1970

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The Children's Vaccine Initiative: Achieving the Vision Company and Vaccine or Product Date of License Date of Revocation Pertussis vaccine 08/03/1914 10/30/1970 Pertussis vaccine, adsorbed 05/03/1948 10/30/1970 Plague 05/14/1942   Poliomyelitis, inactivated monkey kidney cell 04/12/1955 12/28/1978 Small pox 08/21/1903 06/11/1973 Tetanus toxoid 09/25/1940 11/01/1979 Tetanus toxoid, adsorbed 05/04/1949 10/30/1970 Tetanus & diphtheria toxoids adsorbed (for adult use) 11/16/1956 10/30/1970 Typhoid 03/06/1916 10/30/1970 Organon Teknika Corporatione     BCG vaccine 06/21/1989   Parke Davis, Division of Warner Lambert Companya     Adenovirus 09/23/1957 07/29/1980 Adenovirus and influenza, combined aluminium phosphate adsorbed 09/22/1959 07/29/1980 Diphtheria and tetanus toxoids 07/29/1952 10/14/1981 DTP 07/29/1952 10/14/1981 Diphtheria & tetanus toxoids & pertussis vaccine adsorbed 07/08/1952 10/14/1981 Diphtheria toxoid 08/17/1927 10/14/1981 DT, adsorbed 07/08/1952 10/14/1981 DTP adsorbed, poliomyelitis 12/20/1963 10/14/1981 DTP, poliomyelitis adsorbed 03/25/1959 10/14/1981 Influenza 11/26/1945   Pertussis 04/16/1952 10/14/1981 Pertussis vaccine, adsorbed 02/20/1952 10/14/1981 Poliomyelitis, adsorbed 10/04/1960 07/29/1980 Poliomyelitis, inactivated monkey kidney cell 04/12/1955 07/29/1980 Rabies vaccine 08/05/1942 03/21/1973 Tetanus toxoid 05/04/1940 10/14/1981 Tetanus toxoid, adsorbed 07/08/1952 10/14/1981 Typhoid 03/24/1916 02/24/1959 Typhus 03/25/1942 08/05/1947 Pasteur Merieux Vaccins et Serums, S.A.b     Poliomyelitis, inactivated monkey kidney cell 12/21/1990   Rabies vaccine 06/09/1980

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The Children's Vaccine Initiative: Achieving the Vision Company and Vaccine or Product Date of License Date of Revocation Pfizer Ltd.a     Poliovirus, live, oral trivalent 10/28/1966 06/17/1979 Poliovirus, oral type 1 08/17/1961 06/12/1979 Poliovirus, oral type 2 10/06/1961 06/12/1979 Poliovirus, oral type 3 03/27/1962 06/12/1979 Praxis Biologics, Incorporatedd     Haemophilus b conjugate vaccine (diphtheria CRM197 protein conjugate) 12/21/1988   Haemophilus b polysaccharide vaccine 04/12/1985   Research Foundation for Microbial Diseases, Osaka University     Acellular pertussis vaccine concentrate 08/20/1992   Japanese encephalitis virus vaccine inactivated 12/10/1992   SCLAVO s.p.a.f     Cholera 08/19/1976   Diphtheria and tetanus toxoids and pertussis vaccine adsorbed 03/31/1978   Diphtheria toxoid 01/04/1963   DT, adsorbed 03/31/1978   Tetanus toxoid 01/04/1963   Tetanus toxoid, adsorbed 08/05/1970   Tetanus & diphtheria toxoids adsorbed (for adult use) 02/16/1979   SmithKline Beechame     Hepatitis B, recombinant 08/28/1989   Rubella virus, live 03/12/1970 10/05/1982 Swiss Serum Institute     Tetanus toxoid, adsorbed 12/11/1970   Typhoid vaccine, oral, Ty21a 12/15/1989   Takeda Chemical Industries, Ltd.,     Acellular pertussis vaccine concentrate (for further manufacturing) 12/17/1991   Texas Department of Health Resources     Diphtheria & tetanus toxoids & pertussis vaccine adsorbed 07/27/1970 02/06/1979 Diphtheria toxoid 01/06/1963 02/06/1979 DT, adsorbed 07/27/1970 02/06/1979 Pertussis 12/27/1954 02/06/1979

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The Children's Vaccine Initiative: Achieving the Vision Company and Vaccine or Product Date of License Date of Revocation Tetanus toxoid 09/22/1959 02/06/1979 Tetanus & diphtheria toxoids adsorbed (for adult use) 07/27/1970 02/06/1979 Typhoid 07/11/1950 02/06/1979 University of Illinoisa     BCG vaccine 07/07/1950 05/29/1987 Wellcomed     Rubella virus, live 03/01/1977   Wyeth Laboratories     Adenovirus, live, oral, type 4 07/01/1980   Adenovirus, live, oral, type 7 07/01/1980   Cholera 07/16/1952   Diphtheria & tetanus toxoids and pertussis vaccine adsorbed 09/11/1970   Diphtheria toxoid 05/19/1944 05/19/1987 DT, adsorbed 09/11/1970   Influenza 12/13/1961   Pertussis vaccine 07/16/1952 05/19/1987 Rabies vaccine 08/11/1982 08/07/1986 Smallpox 05/19/1944   Tetanus toxoid 05/19/1944   Tetanus toxoid, adsorbed 09/11/1970   Tetanus & diphtheria toxoids adsorbed (for adult use) 09/11/1970   Typhoid 07/16/1952   a Company no longer produces any vaccines. b Connaught Laboratories, Inc., (U.S.) and Connaught Laboratories, Ltd (Canada), are subsidiaries of Pasteur-Mérieux Sérums et Vaccins (France). c Evans-Medical is a division of Medeva International, plc (United Kingdom); Medeva International plc acquired the vaccine business from Wellcome in 1991. d Lederle Laboratories acquired Praxis Biologics in 1989. Lederle-Praxis Biologicals is now a business unit of American Cyanamid. e Company produces one vaccine only for U.S. market. f Sclavo spa is now owned by Ciba-Geigy (Switzerland) and Chiron (U.S.). SOURCE: Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, Maryland.

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The Children's Vaccine Initiative: Achieving the Vision This page in the original is blank.

Representative terms from entire chapter:

pertussis vaccine