Pertussis Vaccine, whole cell
Status: formerly a component of a U.S. DTP vaccine
Organizations involved:
Sanofi Pasteur Inc. – Manuf.; USA mark.; Former
Sanofi Pasteur S.A. – R&D; Tech.; Parent; Former
Cross ref: See the entry for Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed (DTP)/Aventis) (#447), which incorporates this vaccine as a component. See also the entry (#505) for Pertussis Vaccines.
Description: Pertussis Vaccine is an aqueous suspension of formaldehyde inactivated whole Bordetella pertussis bacteria. Bordetella pertussis is cultured on blood-free Bordet Gengou media. The pertussis organisms are harvested and inactivated with thimerosal (a mercury-based antimicrobial/preser-vative; entry #939) and resuspended in physiological saline and thimerosal. This vaccine, not yet adsorbed onto an aluminum adjuvant, was used for manufacture of the pertussis vaccine component of Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed (DTP) vaccine by Aventis Pasteur Inc.
Nomenclature: Pertussis Vaccine/Connaught [BIO]; Pertussis Vaccine [FDA; USAN]; Pertussis Vaccine USP [USP]; pertussis vaccine, cellular [SY]
Companies.: The vaccine was manufactured by Aventis Pasteur Inc. (Swiftwater, PA), CBER/FDA est. no. 0711, now Sanofi Aventis Inc.
FDA class: Biologic PLA
CBER class: Bacterial Antigens and Vaccines
Approvals: Date = 19261016; first approval; granted to Merrell-National Labs., div. of Richardson-Merrell Inc.
Date = 19780103; Original approval date [wrong] according to the CBER/FDA database, the vaccines approvals list in the Jordan Report, and “Licensed Vaccines Currently Distributed in the United States,” Office of Vaccine Research and Review, CBER, FDA, July 29, 1999; However, According to an FDA letter to the company on this date, approval was revoked and granted (reissued) to the new owner, Connaught Labs., Inc.
Indications: product insert/labeling not available
Status: U.S. and other approvals have been withdrawn. Sanofi Pasteur no longer markets a DTP vaccine in the U.S., and the pertussis vaccine component of the company’s current (DTaP) vaccine uses an acellular pertussis vaccine. This component still may be used for manufacture of DTP vaccines used in lesser-developed countries.
Companies involvement:
Full monograph
509 Pertussis Vaccine
Nomenclature:
Pertussis Vaccine [BIO FDA USAN]
Pertussis Vaccine USP [USP]
pertussis vaccine, cellular [SY]
whooping cough vaccine [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1978
Date of 1st FDA approval = 19780103
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, inactivated
bacterial culture <!-- bacterialculture -->
Bordet Gengou medium
Bordetella pertussis
formaldehyde
sodium chloride
thimerosal (mercury derivative)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
FDA application withdrawn
North American coral snake
North American coral snake
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
Copyright© 2020, Biotechnology Information Institute