National Academies Press: OpenBook

The Children's Vaccine Initiative: Achieving the Vision (1993)

Chapter: Appendix H: Historical Record of Vaccine Product License Holders in the United States

« Previous: Appendix G: Immunization Schedules
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×

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.

Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
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Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 196
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 197
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 198
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 199
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 200
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 201
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 202
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 203
Suggested Citation:"Appendix H: Historical Record of Vaccine Product License Holders in the United States." Institute of Medicine. 1993. The Children's Vaccine Initiative: Achieving the Vision. Washington, DC: The National Academies Press. doi: 10.17226/2224.
×
Page 204
Next: Appendix I: Working Group Participants »
The Children's Vaccine Initiative: Achieving the Vision Get This Book
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The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.

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