Status: FDA approved; not marketed

Organizations involved:

Sanofi Pasteur Ltd. – Manuf.; R&D; Tech.

Pasteur Institute – R&D; Tech.; Former

Cross ref: See the BCG Vaccine Products entry (#407) and the other BCG Live and BCG Vaccine products entries.

Description: BCG Vaccine or Mycobax is a formulation of live attenuated strain of Mycobacterium bovis (Bacillus Calmette Guerin; BCG). Mycobax is currently approved, but has not been launched in the U.S. No information was available from the company’s medical information department. The product is substantially identical to BCG Live or TheraCys, used for treatment of bladder cancer, except it is used as a prophylactic tuberculosis vaccine.

Nomenclature: BCG Vaccine/Sanofi [BIO]; Mycobax [TR]; Bacillus of Calmette and Guerin, live [SY]; Mycobacterium bovis, live [SY]

Companies.: Mycobax was apparently developed by and approval for manufacture is held by Sanofi Pasteur Ltd. (Canada), formerly Aventis Pasteur Ltd. (and predecessor companies).

FDA class: Biologic PLA

CBER class: Bacterial Antigens and Vaccines

Approvals: Date = 19670331; first approval, PLA; for BCG Vaccine from Connaught Labs., Ltd. according to 1979 Office of Technology Assessment (OTA) vaccines approvals list and the CBER/FDA database

Date = 19981009; PLA revoked (FDA internal database)

Date = 19981009; first approval for BCG Vaccine (Mycobax), according to FDA Web site approvals listings, the Jordan Report’s list of vaccine approvals, and July 1999 CBER “Licensed Vaccines Currently Distributed in the United States”; The official CBER/FDA database does not show this approval.

Date = 19990104; PLA supplement; Indication = for children and healthcare workers who are continuously exposed to patients infected with contagious tuberculosis or with a resistant strain of TB

Date = 20000224; approval revoked from Connaught Labs.; reissued to new owner, Aventis Pasteur Ltd.

Indications: [from 1998 FDA approval letter]:

for prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at risk of exposure. Should be considered for an infant or child who has a negative tuberculin skin-test result if certain specified circumstances are present. Should be considered for health care workers on an individual basis in certain specified settings.

Status: Mycobax has never been launched and is not marketed in the U.S. It remains on CBER/FDA lists of approved products. Presumably, equivalent vaccine is approved and marketed by Sanofi Pasteur in other countries. FDA had asked PMC/Sanofi to reapply for a license for Mycobax so there would be a second supplier in case of an emergency, after FDA asked PMC to reapply for a license for Mycobax so there would be a second supplier in case of an emergency (after PMC/Sanofi had withdrawn BCG Vaccine when therapeutic Theracys was approved).

No centralized EU approval granted. Presumed