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



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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

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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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