Detailed Safety Review of Anthrax Vaccine Adsorbed
Abstract
To date, 18 human studies have assessed the safety of anthrax vaccination. These studies, some stretching back almost 50 years, reported adverse events after vaccination in varying degrees of detail. The following sections report the design characteristics of these studies, the number of men and women participating, and their specific findings. Among the studies described below, one of two vaccine formulations was used. The Brachman study and the early Fort Detrick studies used anthrax vaccine manufactured according to the original 1950s formula developed at Fort Detrick, Maryland (sometimes called the "Merck vaccine"). Research on this vaccine has been repeatedly accepted by the Food & Drug Administration (FDA) as relevant to the understanding of the safety profile of the current anthrax vaccine, developed in the 1950s. In the I 960s, the production process for anthrax vaccine was improved to increase the concentration of the active ingredient, known as "protective antigen" (increasing the vaccine's potency), and to decrease the amount of other bacterial components in the vaccine (e.g., proteins called edema factor or lethal factor), thus increasing purity. This purer, more potent vaccine, manufactured in Lansing, Michigan, was licensed by the National Institute of Health (NIH) in 1970. Responsibility for vaccine regulation migrated from NIH to the Food & Drug Administration in 1972.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 10, 2001
- Accession Number
- ADA395627