Research on Preparedness for Bioterrorism - Associated Events in Japan: Smallpox Vaccine Preparedness

Abstract

The 2001 anthrax attack in the United States made the deliberate release of biological agents a real issue and forced many countries to improve their bioterrorism preparedness. Smallpox is a threat that requires international preparedness because it spreads from human to human and would be expected to have a high level of lethality. In 2001, Japan restarted the production and stockpiling of a medical countermeasure, the smallpox vaccine LC16m8, which is a cell-cultured, live attenuated smallpox vaccine that was developed in the 1970s in Japan. The Smallpox Vaccine Research Group has continuously worked to characterize LC16m8 genetically, demonstrate the efficacy and safety of the LC16m8 vaccine, reduce the cost of stockpiling through shelf-life extension via the presentation of evidence of its stability in long-term storage, and maintain the quality of the stockpiled vaccine that is available in case of emergency. Maintaining the stockpile and production capacity of “orphan” medical countermeasures has contributed to national security and also to global health. This paper reviews smallpox vaccine preparedness and the surrounding policy issues in Japan as a typical and classic case of biopreparedness research activities and discusses achievements, problems, and future directions.