Maintaining a Safe Blood Supply in an Era of Emerging Pathogens.

Coming shortly after outbreaks of dengue and chikungunya virus in related locations, the recent outbreak of Zika virus in the southern part of the western hemisphere is yet another reminder that infectious pathogens continue to emerge rapidly and can adversely affect public health, including the safety of the blood supply. In response to Zika virus, public health measures that rely largely on donor deferral and sourcing of blood from non-outbreak areas until a blood donor screening test becomes available have been implemented to address the safety of the blood supply in the United States. However, a more universal approach to ensuring blood safety in the setting of rapidly emerging infectious diseases is needed.

Scientists urge DHS to improve Bioterrorism Risk Assessment.

In 2006, the Department of Homeland Security (DHS) completed its first Bioterrorism Risk Assessment (BTRA), intended to be the foundation for DHS's subsequent biennial risk assessments mandated by Homeland Security Presidential Directive 10 (HSPD-10). At the request of DHS, the National Research Council established the Committee on Methodological Improvements to the Department of Homeland Security's Biological Agent Risk Analysis to provide an independent, scientific peer review of the BTRA. The Committee found a number of shortcomings in the BTRA, including a failure to consider terrorists as intelligent adversaries in their models, unnecessary complexity in threat and consequence modeling and simulations, and a lack of focus on risk management. The Committee unanimously concluded that an improved BTRA is needed to provide a more credible foundation for risk-informed decision making.

Removing barriers to global pandemic influenza vaccination.

This article clarifies the regulatory issues surrounding influenza pandemic vaccine for the larger policy community and describes the need for regulatory harmonization. Vaccination would save lives in an influenza pandemic, but a lack of global manufacturing capacity will leave most of the world without access to vaccine. Capacity can be expanded if governments harmonize their regulatory policies. This article details the regulatory approaches taken by the United States, the European Union, and Japan for pandemic vaccine development, three regions that produce the majority of the world's seasonal influenza vaccine. They should quickly converge on regulatory requirements, intellectual property considerations, the use of recombinant DNA techniques for vaccine production, and technical issues about the composition of pandemic vaccine.

Anthrax countermeasures: current status and future needs.

The U.S. government does not yet have the range of medical countermeasures needed to protect its citizens from anthrax and other potential bioweapons. In the event of an anthrax attack, treatment interventions in addition to antibiotics would be needed so that very ill patients can be treated and clean-up crews can be better protected, especially if an engineered strain is used. This article describes specific anthrax countermeasures that are in development, barriers to development, and potential mechanisms the government could use to accelerate the movement of these countermeasures through the pipeline. A key challenge will be to encourage the transition of promising leads from basic research to the product development stage, when they may qualify for BioShield funds.