NCJ Number
192800
Date Published
October 2001
Length
11 pages
Annotation
This testimony before the Subcommittee on National Security, Veterans' Affairs, and International Relations, Committee on Government Reform, House of Representatives, describes changes in the manufacturing process for anthrax vaccine since 1989 and the status of the approval of those changes by the Food and Drug Administration.
Abstract
The original anthrax vaccine was developed in the 1950's and was first produced on a large scale by the pharmaceutical company Merck Sharp & Dohme (now Merck and Co., Inc.). A 1962 clinical study of the safety and effectiveness of the vaccine was the basis for licensure in 1970. The original license was issued to the Michigan Department of Public Health (since 1998, BioPort Corporation). The Michigan facility did not notify the Food and Drug Administration (FDA) of a number of changes made in the manufacturing process in the early 1990's and no specific studies were undertaken to confirm that vaccine quality was not affected. FDA did not inspect the Michigan anthrax production room until 1993. The FDA found a number of deficiencies, many of which were not corrected in a timely manner. Vaccine production was suspended and BioPort has been attempting since then to bring the facility and manufacturing process into compliance. Notes, appendixes