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and Review, CBER, FDA, July 29, 1999; However, According to an FDA letter to the company on this date, approval was revoked and granted (reissued) to the new owner, Connaught Labs., Inc.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Status: U.S. and other approvals have been withdrawn.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.