FDA panel endorses agency's anthrax plan

FDA's Vaccines and Related Biological Products Advisory Committee on Tuesday agreed with the agency's proposed strategy for companies to use the general use prophylaxis (GUP) study design in developing protective antigen (PA)-based anthrax vaccines for post-exposure prophylaxis (PEP) under the Animal Rule. The panel was not asked to vote on a specific question. Instead, the agency asked members to provide guidance on potential bridging strategies to link efficacy data obtained in animals exposed to the Bacillus anthracis spores and treated with PA-based vaccines to antigen response data obtained in humans treated with the same vaccine. In GUP studies, animals are first immunized with the vaccine followed by challenge with the anthrax spores at a defined interval. ...