Approaches to Biohazard Analysis of Select Biodefense Vaccine Candidates

Abstract

Biohazard assessment of biodefense vaccine candidates forms the basis for a facility- and activity-specific risk assessment performed to determine the biosafety levels and general safety standards required for biological product development. As part of our support to the U.S. biodefense vaccine development program, the author performed a systematic biohazard assessment of potential vaccine candidates with the primary objectives to: (a) identify and characterize hazard elements associated with the wild-type and vaccine strains; (b) provide biohazard information on the vaccine candidate to assist Phase 1 clinical trial facility sites; (c) provide a baseline agent and facility-specific risk assessment at clinical trial facilities interested in performing Phase 1 clinical trials; (d) provide comparative hazard profiles of the vaccine candidates with Material Safety Data Sheet (MSDS) for wild-type to identify and establish appropriate protective biosafety levels; and (e) support a determination of the personal...