TABLE 4-11 Vaccines Licensed for Use in the United States Since 1986

Vaccine and Company

Review Time (months)

FDA Approval

Characteristics

BCG live

18.1

05/1990

New approval of an old vaccine for limited indication (treatment of carcinoma-in-situ of the urinary bladder

Connaught Laboratories, Inc.

 

 

 

BCG vaccine

29.5

08/1990

New approval of old vaccine (also indicated for the treatment of carcinoma-in-situ of the urinary bladder

Organon Teknika Corporation

 

 

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed (DTaP)

51.5

12/1991

New acellular pertussis component; shared manufacture with Takeda Chemical Industries, Ltd.

Lederle-Praxis Biologicals

 

 

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed (DTaP)

27.1

08/1992

New acellular component; shared manufacture with Biken (Research Foundation of Osaka University)

Connaught Laboratories, Inc.

 

 

 

Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed and Haemophilus influenzae type b conjugate

14.9

03/1993

New vaccine

Lederle-Praxis Biologicals

 

 

 

Haemophilus influenzae type b meningococcal outer membrane conjugate vaccine

24.9

12/1989

New vaccine (18–60 months)

Merck & Co., Inc.

 

 

 

Haemophilus influenzae type b meningococcal outer membrane conjugate vaccine

4.1

12/1990

Infant indication

Merck & Co., Inc.

 

 

 

Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate)

27.8

03/1993

New vaccine

Pasteur Mérieux Sérums et Vaccins

 

 

 

Haemophilus influenzae type b and diphtheria CRM 197 protein conjugate vaccine

22.5

12/1988

New vaccine (18–60 months)

Praxis Biologics, Inc.

 

 

 

Haemophilus influenzae type b conjugate vaccine

6.9

10/1990

Infant indication

Praxis Biologics, Inc.

 

 

 



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement